Medical device registration application

1、 Domestic Class III medical device registration application

Implementing entity (institution) National Medical Products Administration
Official Guidelines Log in to the online service hall of the State Drug Administration (Internet address: https://zwfw.nmpa.gov.cn/web/taskview/11100000MB0341032Y100017204300101 ）, enter the online registration system to handle relevant matters
Event Type administrative licensing
Charging standard The first registration fee for the domestic third class medical devices: 153,600 yuan.

Announcement of the State Food and Drug Administration on Issuing the Charging Standards for the Registration of Medicines and Medical Devices (No. 53 in 2015): For the first registration application of innovative medical devices proposed by small and micro enterprises, their registration fees will be exempted.
Charging basis The Notice of the National Development and Reform Commission on Releasing the Administrative Fees of the Central Food and Drug Administration (CS [2015] No. 2) and the Notice of the National Development and Reform Commission on Printing and Distributing the Administrative Measures for the Registration Fees of Drugs and Medical Devices (FGJG [2015] No. 1006), Announcement of the State Food and Drug Administration on Issuing the Charging Standards for Registration of Drugs and Medical Devices (2015 No. 53).
Setting basis 1. Article 8 of the Regulations on the Supervision and Administration of Medical Devices (Order No. 680 of the State Council): “Class I medical devices shall be subject to product filing management, and Class II and Class III medical devices shall be subject to product registration management.” Article 9: “Class I medical devices shall be submitted for filing and application for registration of Class II and Class III medical devices. The following materials shall be submitted: (I) product risk analysis materials; (II) product technical requirements; (III) Product inspection report; （4） Clinical evaluation data; （5） Product manual and sample label; （6） Quality management system documents related to product development and production; （7） Other materials required to prove the safety and effectiveness of the product. The medical device registration applicant and the filing person shall be responsible for the authenticity of the submitted materials. ” Article 11: “When applying for the registration of Class III medical devices, the registration applicant shall submit the registration application materials to the food and drug administration under the State Council. The product inspection report in the registration application materials of Class II and Class III medical devices shall be the inspection report issued by the medical device inspection institution.”

2. Chapter V Product Registration of the Administrative Measures for the Registration of Medical Devices (Decree No. 4 of the State Food and Drug Administration)

3. Announcement on Publishing the Requirements for Medical Device Registration Application Materials and the Format of Approval Documents (SFDA Announcement No. 43 in 2014) Annex 4: Requirements and Instructions for Medical Device Registration Application Materials; Appendix 8: List of Basic Requirements for Safety and Effectiveness of Medical Devices.
Statutory completion time limit 188 working days.

1. Acceptance: within 5 working days, the application materials shall be submitted to the technical review institution within 3 working days from the date of acceptance.

2. Review: The technical review institution shall complete the technical review of Class III medical device registration within 90 working days. If it is necessary to engage external experts to review, or the combined products of drugs and machinery need to be jointly reviewed with the drug review agency, the time required shall not be included, and the technical review agency shall inform the applicant in writing of the time required. The time for the quality management system verification and the applicant’s supplementary information shall not be included in the review time limit. The technical review institution shall complete the technical review within 60 working days from the date of receiving the supplementary information.

3. Approval decision: 20 working days;

4. Delivery: 10 working days.
Acceptance conditions The application items fall within the scope of the authority of the department, and the application materials are complete and meet the formal examination requirements.
service object Enterprise legal person
Work type Commitment
Times of arriving at the work site Once
Handling process 1. Acceptance

The applicant applies to the administrative acceptance service hall of the State Food and Drug Administration, and the acceptance personnel shall, according to the application items, comply with the Notice of the State Food and Drug Administration on Publishing the Requirements for Medical Device Registration Application Materials and the Format of Approval Documents (2014 No. 43) According to the requirements of the Operation Specifications of the State Food and Drug Administration on Printing and Distributing the Registration and Approval of Domestic Class III and Imported Medical Devices (SYJXG [2014] No. 208), the application materials should be formally reviewed.

If the application items fall within the scope of the authority of the department, and the application materials are complete and meet the requirements of formal examination, it shall be accepted; If there are errors in the application materials that can be corrected on the spot, the applicant is allowed to correct them on the spot; If the application materials are incomplete or do not meet the formal examination requirements, the applicant shall be informed of all the contents that need to be supplemented and corrected within 5 working days. If the applicant fails to inform within the time limit, the application materials shall be accepted as of the date of receipt; If the application matters do not fall within the scope of the authority of the department, the applicant shall be informed immediately that the application will not be accepted.

2. Review

The acceptance personnel shall, within 3 working days from the date of acceptance, submit the application materials to the technical review institution.

The technical review institution shall complete the technical review of Class III medical device registration within 90 working days. If it is necessary to engage external experts to review, or the combined products of drugs and machinery need to be jointly reviewed with the drug review agency, the time required shall not be included, and the technical review agency shall inform the applicant in writing of the time required. If the applicant needs to supplement or correct the information during the technical review, the technical review institution shall inform the applicant of all the contents that need to be supplemented or corrected at one time. The applicant shall provide supplementary materials at one time within one year in accordance with the requirements of the Notice of Correction. The technical review institution shall complete the technical review within 60 working days from the date of receiving the supplementary information. The time for the quality management system verification and the applicant’s supplementary information shall not be included in the review time limit.

3. Licensing Decision

The SDA shall make a decision within 20 working days after the completion of the technical review, and approve the registration if it meets the requirements of safety and effectiveness. If the registration is not approved, the applicant shall explain the reasons in writing and inform the applicant of the right to apply for reexamination and apply for administrative reconsideration or bring an administrative lawsuit according to law.

4. Service

Within 10 working days from the date of making the approval decision, the Administrative Affairs Acceptance Service and Complaint Reporting Center of the State Drug Administration will deliver the administrative licensing decision to the applicant.
Application materials (1) Application form;

(2) Supporting documents;

(3) List of basic requirements for safety and effectiveness of medical devices;

(4) Overview data;

(5) Research data;

(6) Manufacturing information;

(7) Clinical evaluation data;

(8) Product risk analysis data;

(9) Product technical requirements;

(10) Product registration inspection report;

(11) Manual and label sample;

(12) Declaration of conformity.
Other instructions The administrative counterpart can refer to the Notice of the State Food and Drug Administration on the Issuance of Technical Guidelines for Clinical Evaluation of Medical Devices (No. 14 in 2015) to prepare clinical evaluation data.

 

2、 Application for registration of Class III in vitro diagnostic reagents in China

Implementing entity (institution) National Medical Products Administration
Official Guidelines Log in to the online service hall of the State Drug Administration (Internet address: https://zwfw.nmpa.gov.cn/web/taskview/11100000MB0341032Y100017204300102 ）, enter the online registration system to handle relevant matters
Event Type administrative licensing
Charging standard The first registration fee for the domestic third class medical devices: 153,600 yuan.

Announcement of the State Food and Drug Administration on Issuing the Charging Standards for the Registration of Medicines and Medical Devices (No. 53 in 2015): For the first registration application of innovative medical devices proposed by small and micro enterprises, their registration fees will be exempted.
Charging basis The Notice of the National Development and Reform Commission on Releasing the Administrative Fees of the Central Food and Drug Administration (CS [2015] No. 2) and the Notice of the National Development and Reform Commission on Printing and Distributing the Administrative Measures for the Registration Fees of Drugs and Medical Devices (FGJG [2015] No. 1006), Announcement of the State Food and Drug Administration on Issuing the Charging Standards for Registration of Drugs and Medical Devices (2015 No. 53).
Setting basis 1. Article 8 of the Regulations on the Supervision and Administration of Medical Devices (Order No. 680 of the State Council): “Class I medical devices shall be subject to product filing management, and Class II and III medical devices shall be subject to product registration management. Article 9 For the filing of Class I medical devices and the application for registration of Class II and III medical devices, the following materials shall be submitted: (I) product risk analysis materials; (II) product technical requirements; (III) Product inspection report; （4） Clinical evaluation data; （5） Product manual and sample label; （6） Quality management system documents related to product development and production; （7） Other materials required to prove the safety and effectiveness of the product. The medical device registration applicant and the filing person shall be responsible for the authenticity of the submitted materials. ” Article 11: “When applying for the registration of Class III medical devices, the registration applicant shall submit the registration application materials to the food and drug administration under the State Council. The product inspection report in the registration application materials of Class II and Class III medical devices shall be the inspection report issued by the medical device inspection institution.”

2. Chapter VI of the Measures for the Administration of In Vitro Diagnostic Reagent Registration (Decree No. 5 of the State Food and Drug Administration)

3. Announcement on Publishing the Application Data Requirements for In Vitro Diagnostic Reagent Registration and the Format of Approval Documents (State Food and Drug Administration 2014 No. 44) Appendix 3
Statutory completion time limit 188 working days.

1. Acceptance: within 5 working days, the application materials shall be submitted to the technical review institution within 3 working days from the date of acceptance.

2. Review: The technical review institution shall complete the technical review of Class III medical device registration within 90 working days. If it is necessary to engage external experts to review, or the combined products of drugs and machinery need to be jointly reviewed with the drug review agency, the time required shall not be included, and the technical review agency shall inform the applicant in writing of the time required. The time for the quality management system verification and the applicant’s supplementary information shall not be included in the review time limit. The technical review institution shall complete the technical review within 60 working days from the date of receiving the supplementary information.

3. Approval decision: 20 working days;

4. Delivery: 10 working days.
Acceptance conditions The application items fall within the scope of the authority of the department, and the application materials are complete and meet the formal examination requirements.
service object Enterprise legal person
Work type Commitment
Times of arriving at the work site Once
Handling process 1. Acceptance

The applicant submitted an application to the administrative acceptance service hall of the State Food and Drug Administration, and the acceptor, according to the application items, followed the Notice of the State Food and Drug Administration on Publishing the Application Data Requirements for the Registration of In Vitro Diagnostic Reagents and the Format of Approval Documents (2014 No. 44) According to the requirements of the Operation Specifications of the State Food and Drug Administration on Printing and Distributing the Registration and Approval of Domestic Class III and Imported Medical Devices (SYJXG [2014] No. 208), the application materials should be formally reviewed.

If the application items fall within the scope of the authority of the department, and the application materials are complete and meet the requirements of formal examination, it shall be accepted; If there are errors in the application materials that can be corrected on the spot, the applicant is allowed to correct them on the spot; If the application materials are incomplete or do not meet the formal examination requirements, the applicant shall be informed of all the contents that need to be supplemented and corrected within 5 working days. If the applicant fails to inform within the time limit, the application materials shall be accepted as of the date of receipt; If the application matters do not fall within the scope of the authority of the department, the applicant shall be informed immediately that the application will not be accepted.

2. Review

The acceptance personnel shall, within 3 working days from the date of acceptance, submit the application materials to the technical review institution.

The technical review institution shall complete the technical review of Class III medical device registration within 90 working days. If it is necessary to engage external experts to review, or the combined products of drugs and machinery need to be jointly reviewed with the drug review agency, the time required shall not be included, and the technical review agency shall inform the applicant in writing of the time required. If the applicant needs to supplement or correct the information during the technical review, the technical review institution shall inform the applicant of all the contents that need to be supplemented or corrected at one time. The applicant shall provide supplementary materials at one time within one year in accordance with the requirements of the Notice of Correction. The technical review institution shall complete the technical review within 60 working days from the date of receiving the supplementary information. The time for the quality management system verification and the applicant’s supplementary information shall not be included in the review time limit.

3. Licensing Decision

The SDA shall make a decision within 20 working days after the completion of the technical review, and approve the registration if it meets the requirements of safety and effectiveness. If the registration is not approved, the applicant shall explain the reasons in writing and inform the applicant of the right to apply for reexamination and apply for administrative reconsideration or bring an administrative lawsuit according to law.

4. Service

Within 10 working days from the date of making the approval decision, the Administrative Affairs Acceptance Service and Complaint Reporting Center of the State Drug Administration will deliver the administrative licensing decision to the applicant.
Application materials (1) Application form;

(2) Supporting documents;

(3) Overview data;

(3) Research data of main raw materials;

(4) Research data of main production processes and reaction systems;

(5) Analyze performance evaluation data;

(6) Positive judgment value or reference interval determination data;

(7) Stability study data;

(8) Production and self inspection records;

(9) Clinical evaluation data;

(10) Product risk analysis data;

(11) Product technical requirements;

(12) Product registration inspection report;

(13) Product manual;

(14) Label sample;

(15) Declaration of conformity.
Other instructions According to the relevant requirements of Article 32 of the Measures for the Administration of the Registration of In Vitro Diagnostic Reagents (Decree No. 5 of the General Administration), the applicant for Class III products shall select at least three (including three) qualified clinical trial institutions to carry out clinical trials in accordance with the relevant provisions.

 

3、 Application for registration of imported medical devices

Implementing entity (institution) National Medical Products Administration
Official Guidelines Log in to the online service hall of the State Drug Administration (Internet address: https://zwfw.nmpa.gov.cn/web/taskview/11100000MB0341032Y100017204400101 ）, enter the online registration system to handle relevant matters
Event Type administrative licensing
Charging standard First registration fee for imported Class III medical instruments: 308800 yuan; First registration fee for imported Class II medical instruments: 210900 yuan
Charging basis The Notice of the National Development and Reform Commission on Releasing the Administrative Fees of the Central Food and Drug Administration (CS [2015] No. 2) and the Notice of the National Development and Reform Commission on Printing and Distributing the Administrative Measures for the Registration Fees of Drugs and Medical Devices (FGJG [2015] No. 1006), Announcement of the State Food and Drug Administration on Issuing the Charging Standards for Registration of Drugs and Medical Devices (2015 No. 53).
Setting basis 1. Article 8 of the Regulations on the Supervision and Administration of Medical Devices (Order No. 680 of the State Council): “Class I medical devices shall be subject to product filing management, and Class II and Class III medical devices shall be subject to product registration management.” Article 9: “Class I medical devices shall be submitted for filing and application for registration of Class II and Class III medical devices. The following materials shall be submitted: (I) product risk analysis materials; (II) product technical requirements; (III) Product inspection report; （4） Clinical evaluation data; （5） Product manual and sample label; （6） Quality management system documents related to product development and production; （7） Other materials required to prove the safety and effectiveness of the product. The medical device registration applicant and the filing person shall be responsible for the authenticity of the submitted materials. ” Article 11: “For overseas manufacturers exporting Class II and Class III medical devices to China, their representative offices established in China or designated enterprise legal persons in China as agents shall submit registration application materials and the country (region) where the applicant is located to the food and drug regulatory authority under the State Council The certification document of the competent department approving the marketing of the medical device. The product inspection report in the Class II and Class III medical device product registration application materials shall be the inspection report issued by the medical device inspection institution; Clinical evaluation data shall include clinical trial reports, except for medical devices exempted from clinical trials according to Article 17 of these Regulations. “)

2. Chapter V Product Registration of the Administrative Measures for the Registration of Medical Devices (Decree No. 4 of the State Food and Drug Administration)

3. Announcement on Publishing the Requirements for Medical Device Registration Application Materials and the Format of Approval Documents (SFDA Announcement No. 43 in 2014) Annex 4: Requirements and Instructions for Medical Device Registration Application Materials; Annex 8: List of Basic Requirements for Safety and Effectiveness of Medical Devices
Statutory completion time limit 188 working days.

1. Acceptance: within 5 working days, the application materials shall be submitted to the technical review institution within 3 working days from the date of acceptance.

2. Review: The technical review institution shall complete the technical review of the registration of Class II medical devices within 60 working days and the technical review of Class III medical devices within 90 working days. If it is necessary to engage external experts to review, or the combined products of drugs and machinery need to be jointly reviewed with the drug review agency, the time required shall not be included, and the technical review agency shall inform the applicant in writing of the time required. The time for the quality management system verification and the applicant’s supplementary information shall not be included in the review time limit. The technical review institution shall complete the technical review within 60 working days from the date of receiving the supplementary information.

3. Approval decision: 20 working days;

4. Delivery: 10 working days.
Acceptance conditions The application items fall within the scope of the authority of the department, and the application materials are complete and meet the formal examination requirements.
service object Enterprise legal person
Work type Commitment
Times of arriving at the work site Once
Handling process 1. Acceptance

The applicant applies to the administrative acceptance service hall of the State Food and Drug Administration, and the acceptance personnel shall, according to the application items, comply with the Notice of the State Food and Drug Administration on Publishing the Requirements for Medical Device Registration Application Materials and the Format of Approval Documents (2014 No. 43) According to the requirements of the Operation Specifications of the State Food and Drug Administration on Printing and Distributing the Registration and Approval of Domestic Class III and Imported Medical Devices (SYJXG [2014] No. 208), the application materials should be formally reviewed.

If the application items fall within the scope of the authority of the department, and the application materials are complete and meet the requirements of formal examination, it shall be accepted; If there are errors in the application materials that can be corrected on the spot, the applicant is allowed to correct them on the spot; If the application materials are incomplete or do not meet the formal examination requirements, the applicant shall be informed of all the contents that need to be supplemented and corrected within 5 working days. If the applicant fails to inform within the time limit, the application materials shall be accepted as of the date of receipt; If the application matters do not fall within the scope of the authority of the department, the applicant shall be informed immediately that the application will not be accepted.

2. Review

The acceptance personnel shall, within 3 working days from the date of acceptance, submit the application materials to the technical review institution.

The technical review institution shall complete the technical review of the registration of Class II medical devices within 60 working days and the technical review of Class III medical devices within 90 working days. If it is necessary to engage external experts to review, or the combined products of drugs and machinery need to be jointly reviewed with the drug review agency, the time required shall not be included, and the technical review agency shall inform the applicant in writing of the time required. If the applicant needs to supplement or correct the information during the technical review, the technical review institution shall inform the applicant of all the contents that need to be supplemented or corrected at one time. The applicant shall provide supplementary materials at one time within one year in accordance with the requirements of the Notice of Correction. The technical review institution shall complete the technical review within 60 working days from the date of receiving the supplementary information. The time for the quality management system verification and the applicant’s supplementary information shall not be included in the review time limit.

3. Licensing Decision

The SDA shall make a decision within 20 working days after the completion of the technical review, and approve the registration if it meets the requirements of safety and effectiveness. If the registration is not approved, the applicant shall explain the reasons in writing and inform the applicant of the right to apply for reexamination and apply for administrative reconsideration or bring an administrative lawsuit according to law.

4. Service

Within 10 working days from the date of making the approval decision, the Administrative Affairs Acceptance Service and Complaint Reporting Center of the State Drug Administration will deliver the administrative licensing decision to the applicant.
Application materials (1) Application form;

(2) Supporting documents;

(3) List of basic requirements for safety and effectiveness of medical devices;

(4) Overview data;

(5) Research data;

(6) Manufacturing information;

(7) Clinical evaluation data;

(8) Product risk analysis data;

(9) Product technical requirements;

(10) Product registration inspection report;

(11) Manual and label sample;

(12) Declaration of conformity.
Other instructions According to the requirements of the Operation Specifications for the Registration and Approval of Domestic Class III and Imported Medical Devices (SYJXG [2014] No. 208), the application materials for imported products, unless otherwise specified, shall be signed and sealed by the applicant in the original text, and the Chinese materials shall be signed and sealed by the agent. The “signature” of the original materials refers to the signature of the applicant’s legal representative or person in charge, or the signature and seal of the organization, and the notarial copy issued by the notary office in the place where the applicant is located shall be submitted.

 

4、 Application for registration of imported in vitro diagnostic reagents

Implementing entity (institution) National Medical Products Administration
Official Guidelines Log in to the online service hall of the State Drug Administration (Internet address: https://zwfw.nmpa.gov.cn/web/taskview/11100000MB0341032Y100017204400102 ）, enter the online registration system to handle relevant matters
Event Type administrative licensing
Charging standard First registration fee for imported Class III medical instruments: 308800 yuan; First registration fee for imported Class II medical instruments: 210900 yuan
Charging basis The Notice of the National Development and Reform Commission on Releasing the Administrative Fees of the Central Food and Drug Administration (CS [2015] No. 2) and the Notice of the National Development and Reform Commission on Printing and Distributing the Administrative Measures for the Registration Fees of Drugs and Medical Devices (FGJG [2015] No. 1006), Announcement of the State Food and Drug Administration on Issuing the Charging Standards for Registration of Drugs and Medical Devices (2015 No. 53).
Setting basis 1. Article 8 of the Regulations on the Supervision and Administration of Medical Devices (Order No. 680 of the State Council): “Class I medical devices shall be subject to product filing management, and Class II and III medical devices shall be subject to product registration management. Article 9 For the filing of Class I medical devices and the application for registration of Class II and III medical devices, the following materials shall be submitted: (I) product risk analysis materials; (II) product technical requirements; (III) Product inspection report; （4） Clinical evaluation data; （5） Product manual and sample label; （6） Quality management system documents related to product development and production; （7） Other materials required to prove the safety and effectiveness of the product. The medical device registration applicant and the filing person shall be responsible for the authenticity of the submitted materials. ” Article 11: “When applying for the registration of Class III medical devices, the registration applicant shall submit the registration application materials to the food and drug administration under the State Council. The product inspection report in the registration application materials of Class II and Class III medical devices shall be the inspection report issued by the medical device inspection institution.”

2. Chapter VI of the Measures for the Administration of In Vitro Diagnostic Reagent Registration (Decree No. 5 of the State Food and Drug Administration)

3. Announcement on Publishing the Application Data Requirements for In Vitro Diagnostic Reagent Registration and the Format of Approval Documents (State Food and Drug Administration 2014 No. 44) Appendix 3
Statutory completion time limit 188 working days.

1. Acceptance: within 5 working days, the application materials shall be submitted to the technical review institution within 3 working days from the date of acceptance.

2. Review: The technical review institution shall complete the technical review of the registration of Class II medical devices within 60 working days and the technical review of Class III medical devices within 90 working days. If it is necessary to engage external experts to review, or the combined products of drugs and machinery need to be jointly reviewed with the drug review agency, the time required shall not be included, and the technical review agency shall inform the applicant in writing of the time required. The time for the quality management system verification and the applicant’s supplementary information shall not be included in the review time limit. The technical review institution shall complete the technical review within 60 working days from the date of receiving the supplementary information.

3. Approval decision: 20 working days;

4. Delivery: 10 working days.
Acceptance conditions The application items fall within the scope of the authority of the department, and the application materials are complete and meet the formal examination requirements.
service object Enterprise legal person
Work type Commitment
Times of arriving at the work site Once
Handling process 1. Acceptance

The applicant submitted an application to the administrative acceptance service hall of the State Food and Drug Administration, and the acceptor, according to the application items, followed the Notice of the State Food and Drug Administration on Publishing the Application Data Requirements for the Registration of In Vitro Diagnostic Reagents and the Format of Approval Documents (2014 No. 44) According to the requirements of the Operation Specifications of the State Food and Drug Administration on Printing and Distributing the Registration and Approval of Domestic Class III and Imported Medical Devices (SYJXG [2014] No. 208), the application materials should be formally reviewed.

If the application items fall within the scope of the authority of the department, and the application materials are complete and meet the requirements of formal examination, it shall be accepted; If there are errors in the application materials that can be corrected on the spot, the applicant is allowed to correct them on the spot; If the application materials are incomplete or do not meet the formal examination requirements, the applicant shall be informed of all the contents that need to be supplemented and corrected within 5 working days. If the applicant fails to inform within the time limit, the application materials shall be accepted as of the date of receipt; If the application matters do not fall within the scope of the authority of the department, the applicant shall be informed immediately that the application will not be accepted.

2. Review

The acceptance personnel shall, within 3 working days from the date of acceptance, submit the application materials to the technical review institution.

The technical review institution shall complete the technical review of Class III medical device registration within 90 working days. If it is necessary to engage external experts to review, or the combined products of drugs and machinery need to be jointly reviewed with the drug review agency, the time required shall not be included, and the technical review agency shall inform the applicant in writing of the time required. If the applicant needs to supplement or correct the information during the technical review, the technical review institution shall inform the applicant of all the contents that need to be supplemented or corrected at one time. The applicant shall provide supplementary materials at one time within one year in accordance with the requirements of the Notice of Correction. The technical review institution shall complete the technical review within 60 working days from the date of receiving the supplementary information. The time for the quality management system verification and the applicant’s supplementary information shall not be included in the review time limit.

3. Licensing Decision

The SDA shall make a decision within 20 working days after the completion of the technical review, and approve the registration if it meets the requirements of safety and effectiveness. If the registration is not approved, the applicant shall explain the reasons in writing and inform the applicant of the right to apply for reexamination and apply for administrative reconsideration or bring an administrative lawsuit according to law.

4. Service

Within 10 working days from the date of making the approval decision, the Administrative Affairs Acceptance Service and Complaint Reporting Center of the State Drug Administration will deliver the administrative licensing decision to the applicant.
Application materials (1) Application form;

(2) Supporting documents;

(3) Overview data;

(4) Research data of main raw materials;

(5) Research data of main production processes and reaction systems;

(6) Analyze performance evaluation data;

(7) Positive judgment value or reference interval determination data;

(8) Stability study data;

(9) Production and self inspection records;

(10) Clinical evaluation data;

(11) Product risk analysis data;

(12) Product technical requirements Product technical requirements;

(13) Product registration inspection report;

(14) Product manual;

(15) Label sample;

(16) Declaration of conformity.
Other instructions According to the requirements of the Operation Specifications for the Registration and Approval of Domestic Class III and Imported Medical Devices (SYJXG [2014] No. 208), the application materials for imported products, unless otherwise specified, shall be signed and sealed by the applicant in the original text, and the Chinese materials shall be signed and sealed by the agent. The “signature” of the original materials refers to the signature of the applicant’s legal representative or person in charge, or the signature and seal of the organization, and the notarial copy issued by the notary office in the place where the applicant is located shall be submitted.

 

5、 Clinical trial approval of Class III high-risk medical devices

Implementing entity (institution) National Medical Products Administration
Official Guidelines Log in to the online service hall of the State Drug Administration (Internet address: https://zwfw.nmpa.gov.cn/web/taskview/11100000MB0341032Y100017204500001 ）, enter the online registration system to handle relevant matters
Event Type administrative licensing
Charging standard 43200 yuan
Charging basis The Notice of the National Development and Reform Commission on Releasing the Administrative Fees of the Central Food and Drug Administration (CS [2015] No. 2) and the Notice of the National Development and Reform Commission on Printing and Distributing the Administrative Measures for the Registration Fees of Drugs and Medical Devices (FGJG [2015] No. 1006), Announcement of the State Food and Drug Administration on Issuing the Charging Standards for Registration of Drugs and Medical Devices (2015 No. 53).
Setting basis 1. Article 11 of the Regulations on the Supervision and Administration of Medical Devices (Order No. 680 of the State Council): “The product inspection report in the registration application materials of Class II and Class III medical devices shall be the inspection report issued by the medical device inspection institution; the clinical evaluation data shall include the clinical test report, except for the medical devices exempted from clinical trials according to the provisions of Article 17 of these Regulations.” Article 17: “Clinical trials are not required for the filing of Class I medical devices. Clinical trials should be conducted when applying for the registration of Class II and Class III medical devices. However, clinical trials can be exempted under one of the following circumstances: (I) The working mechanism is clear, the design is finalized, the production process is mature, the same type of medical devices that have been on the market have been in clinical use for many years without serious adverse event records, and the routine use is not changed; （2） The medical device can be proved to be safe and effective through non clinical evaluation; （3） It can prove that the medical device is safe and effective by analyzing and evaluating the data obtained from clinical trials or clinical use of the same type of medical device. The list of medical devices exempted from clinical trials shall be formulated, adjusted and published by the food and drug regulatory department under the State Council. ” Article 18: “Clinical trials of medical devices should be conducted in clinical trial institutions with appropriate conditions in accordance with the requirements of the Quality Management Standards for Clinical Trials of Medical Devices, and should be filed with the food and drug administration of the people’s government of the province, autonomous region, or municipality directly under the Central Government where the clinical trial proposer is located. The food and drug administration accepting the clinical trial filing should report the filing to the food and drug administration at the same level in the place where the clinical trial institution is located Supervision and management departments and health and family planning authorities. The clinical test institutions of medical devices shall implement the record management. The conditions that clinical test institutions of medical devices should meet, the filing management measures and the clinical test quality management standards shall be formulated and published by the food and drug regulatory department of the State Council together with the health and family planning department of the State Council. ” Article 19: “The clinical trials of the third class medical devices that pose a high risk to human beings should be approved by the food and drug administration under the State Council. The catalogue of the third class medical devices that pose a high risk to human beings in clinical trials should be formulated, adjusted and published by the food and drug administration under the State Council. When the food and drug administration under the State Council approves the clinical trials, the equipment and specialties of the institutions that plan to undertake the clinical trials of medical devices should be Personnel and other conditions, risk degree of the medical device, clinical trial implementation plan, comparative analysis report of clinical benefits and risks, etc. If the clinical trial is approved, the proposer of the clinical trial and the food and drug regulatory department and the health and family planning department of the people’s government of the province, autonomous region, or municipality directly under the Central Government where the clinical trial institution is located shall be notified. ”

2. Article 16 of the Administrative Measures for the Registration of Medical Devices (Order No. 4 of the State Food and Drug Administration): “The production of registered inspection samples shall meet the relevant requirements of the quality management system of medical devices. Only those qualified in the registration inspection can conduct clinical trials or apply for registration.” Chapter IV Clinical Evaluation

3. Announcement on Publishing the Requirements for Medical Device Registration Application Materials and the Format of Approval Documents (SFDA Announcement No. 43 in 2014) Annex 7: Requirements and Instructions for Medical Device Clinical Trial Approval Application Materials
Statutory completion time limit 118 working days.

1. Acceptance: within 5 working days, the application materials shall be submitted to the technical review institution within 3 working days from the date of acceptance.

2. Review: The technical review institution shall complete the technical review within 40 working days. The time for the applicant to supplement the information shall not be included in the time limit for review. The technical review institution shall complete the technical review within 40 working days from the date of receiving the supplementary information.

3. Approval decision: 20 working days;

4. Delivery: 10 working days.
Acceptance conditions The application items fall within the scope of the authority of the department, and the application materials are complete and meet the formal examination requirements.
service object Enterprise legal person
Work type Commitment
Times of arriving at the work site Once
Handling process 1. Acceptance

The applicant applies to the administrative acceptance service hall of the State Food and Drug Administration, and the acceptance personnel shall follow the Notice of the State Food and Drug Administration on Publishing the Requirements for Medical Device Registration Application Materials and the Format of Approval Documents (2014 No. 43) According to the requirements of the Operation Specifications of the State Food and Drug Administration on Printing and Distributing the Registration and Approval of Domestic Class III and Imported Medical Devices (SYJXG [2014] No. 208), the application materials should be formally reviewed.

If the application items fall within the scope of the authority of the department, and the application materials are complete and meet the requirements of formal examination, it shall be accepted; If there are errors in the application materials that can be corrected on the spot, the applicant is allowed to correct them on the spot; If the application materials are incomplete or do not meet the formal examination requirements, the applicant shall be informed of all the contents that need to be supplemented and corrected within 5 working days. If the applicant fails to inform within the time limit, the application materials shall be accepted as of the date of receipt; If the application matters do not fall within the scope of the authority of the department, the applicant shall be informed immediately that the application will not be accepted.

2. Review

The acceptance personnel shall, within 3 working days from the date of acceptance, submit the application materials to the technical review institution. The technical review institution shall complete the technical review within 40 working days. If the applicant needs to supplement or correct the information during the technical review, the technical review institution shall inform the applicant of all the contents that need to be supplemented or corrected at one time. The applicant shall provide supplementary materials at one time within one year in accordance with the requirements of the Notice of Correction. The technical review institution shall complete the technical review within 40 working days from the date of receiving the supplementary information. The time for the applicant to supplement information shall not be included in the review time limit.

3. Licensing Decision

The Center for Technical Evaluation of Medical Devices under the State Drug Administration shall make a decision within 20 working days after the completion of the technical evaluation. Where clinical trials are approved, approval documents for clinical trials of medical devices shall be issued; If approval is not granted, reasons shall be given in writing.

4. Service

Within 10 working days from the date of making the approval decision, the Administrative Affairs Acceptance Service and Complaint Reporting Center of the State Food and Drug Administration will deliver the administrative licensing decision to the applicant.
Application materials (1) Application form;

(2) Supporting documents; (Including: (I) The domestic applicant shall submit: 1. The copy of the duplicate of the business license of the enterprise. 2. Copy of organization code certificate. （2） The overseas applicant shall submit: 1. The certification documents and legal qualification certificates issued by the competent department of medical devices in the country (region) where the overseas applicant is registered or where the production address is located. 2. The power of attorney, the letter of commitment of the agent and the duplicate of the business license or the duplicate of the organization registration certificate of the overseas applicant’s designated agent in China.)

(3) Description of test products; (Generally, it shall include: (I) The applicant’s pre clinical research data on the test medical device. For example, laboratory research, animal testing, etc. （2） Published literature and critical reviews related to the evaluation of the safety and effectiveness of medical devices for testing. （3） Research and development, marketing and clinical application of similar products at home and abroad, as well as comparative data on working principle, structural composition, manufacturing materials, technical parameters and scope of application between medical devices for testing and similar products already on the market at home and abroad. （4） Adverse event information related to the test medical device. （5） Comparative analysis report on benefits and risks of clinical trial. （6） Other required research materials.)

(4) Product technical requirements;

(5) Registration inspection report and pre evaluation opinions issued by the medical device inspection institution;

(6) Manual and label sample;

(7) Clinical trial protocol; (The clinical trial plan shall comply with the relevant requirements of the Quality Management Standards for Clinical Trials of Medical Devices issued by the State Food and Drug Administration, and the analytical data proving the scientific rationality of the clinical trial plan shall be submitted.)

(8) The Ethics Committee agrees with the written opinion on the implementation of the clinical trial; (Written comments on approval of the clinical trial by the ethics committee of all clinical trial institutions shall be submitted)

(9) Declaration of conformity. (1) The applicant declares that this product complies with the requirements of the Administrative Measures for the Registration of Medical Devices and relevant regulations. 2. The applicant declares the authenticity of the materials submitted.)
Other instructions According to the relevant requirements of Article 24 of the Administrative Measures for the Registration of Medical Devices, clinical trials of Class III medical devices pose a high risk to human beings and should be approved by the State Food and Drug Administration. The catalogue of Category III medical devices requiring clinical trial approval shall be formulated, adjusted and published by the State Food and Drug Administration. At present, please refer to the Notice of the State Food and Drug Administration on Issuing the Catalog of Class III Medical Devices Subject to Clinical Trial Approval (2014 No. 14).

 

6、 Filing of imported Class I medical instruments

Implementing entity (institution) National Medical Products Administration
Official Guidelines Log in to the online service hall of the State Drug Administration (Internet address: https://zwfw.nmpa.gov.cn/web/taskview/11100000MB0341032Y100207201300101 ）, enter the online registration system to handle relevant matters
Event Type administrative licensing
Charging standard No charge
Charging basis /
Setting basis Article 10 of the Regulations on the Supervision and Administration of Medical Devices (Decree No. 650 of the State Council): “For the filing of Class I medical device products, the filing person shall submit the filing materials to the food and drug regulatory department of the municipal people’s government with districts. The product inspection report can be the self inspection report of the filing person; the clinical evaluation data does not include the clinical trial report, but can be the data obtained through literature and clinical use of similar products to prove the safety and effectiveness of the medical device. Export Class I medical devices to China For overseas manufacturers of devices, their representative offices established in China or designated enterprise legal persons in China shall act as agents, and submit to the food and drug regulatory authority under the State Council the filing materials and the documents certifying that the competent authorities of the country (region) where the registrant is located permit the medical devices to be marketed. In case of any change in the items specified in the filing materials, the change shall be filed with the original filing department. “
Statutory completion time limit None
Acceptance conditions Filing matters fall within the authority of the department, and the filing materials are complete and meet the formal requirements
service object Enterprise legal person
Work type Commitment
Times of arriving at the work site Once
Handling process The filer shall submit materials in accordance with the provisions of the Announcement of the State Food and Drug Administration on Matters Related to the Filing of Class I Medical Devices (2014 No. 26). The filing matters fall within the scope of the authority of the department. If the filing materials are complete and conform to the form requirements, they shall be filed on the spot, and the filing certificate affixed with the exclusive seal of the department by the filing person shall be provided. The information published in the filing information form shall be published on the website of the State Food and Drug Administration. If the filing materials are not complete or do not conform to the prescribed form, it shall inform all the contents that need to be supplemented and corrected at one time. If the filing is not allowed, it shall inform the filing person and explain the reasons.
Application materials (1) Class I medical device filing form;

(2) Safety risk analysis report;

(3) Product technical requirements;

(4) Product inspection report;

(5) Clinical evaluation data;

(6) Product manual and sample label design of minimum sales unit;

(7) Manufacturing information;

(8) Supporting documents;

(9) Declaration of conformity.
Other instructions According to the relevant requirements of the Notice of the General Office of the Food and Drug Administration on Matters Related to the Implementation of the Filing of Class I Medical Devices (SFDBXG [2014] No. 174), the medical devices listed in the Class I medical device product catalog and the Class I in vitro diagnostic reagents in the classification subcategory of in vitro diagnostic reagents, or the products classified as Class I medical devices, shall be filed according to the provisions of Announcement 26.

 

7、 Classification of medical devices

Implementing entity (institution) National Medical Products Administration
Official Guidelines Log in to the online service hall of the State Drug Administration (Internet address: https://zwfw.nmpa.gov.cn/web/taskview/11100000MB0341032Y100207202300001 ）, enter the online registration system to handle relevant matters
Event Type public service
Charging standard No charge
Charging basis /
Setting basis In the Notice of the General Office of the State Administration on Standardizing the Work Related to the Classification of Medical Devices (SFDBXG [2017] No. 127), “(III) The Standards Management Center is responsible for organizing research and review on the application for classification and definition of imported and Hong Kong, Macao and Taiwan products, and the application for classification and definition issued by the provincial food and drug administration for pre classification and definition”.
Statutory completion time limit For the newly developed medical devices that have not been listed in the Classification Catalogue and other documents, the Standards Management Center shall complete the classification confirmation within 20 working days from the date of accepting the classification definition application. The time required for supplementary information and expert discussion is not included in the time limit. There is no time limit for application for classification and definition under other circumstances.
Acceptance conditions According to the Notice of the General Office of the General Administration of the People’s Republic of China on Regulating the Classification of Medical Devices (SFDBXG [2017] No. 127)

1、 Application method

The applicant accesses the “Medical Device Classification and Definition Information System” page of the secondary website of the “Medical Device Standard Management Institute” through the website of the China Institute for Food and Drug Control (the Medical Device Standard Management Center of the State Food and Drug Administration) (website: https://www.nifdc.org.cn/nifdc/bshff/ylqxbzhgl/index.html ）Click to enter the “Medical Device Classification and Definition Information System”, fill in the Application Form for Classification and Definition after registration, and upload other application materials.

Print the Application Form for Classification and Definition online, and send it to the relevant units together with other application materials (which should be identical to the uploaded application materials), stamped with the applicant’s cross page seal. The relevant materials of domestic products shall be sent to the provincial food and drug administration where the applicant is located, and the relevant materials of imported and Hong Kong, Macao and Taiwan products shall be sent to the Medical Device Standards Management Center of the State Food and Drug Administration (address: Room B404, Building 4, Yard 31, Huatuo Road, Biological Medicine Industry Base, Daxing District, Beijing, zip code: 102629).

2、 Requirements for application materials

（1） Application form for classification and definition;

（2） Product photos and/or product structure drawings;

（3） Product technical requirements and product specifications (draft);

（4） Certification materials for import listing (if any);

（5） Self guarantee statement of the authenticity of materials;

（6） Other materials related to product classification and definition. For newly developed products that have not been listed in the Classification Catalogue and other documents, at least the following shall be submitted:

1. Analysis and comparison with relevant products already on the market at home and abroad, relevant products in the Classification Catalog or the classification definition notice document, and description of the judgment basis for products that meet the requirements of newly developed products that have not been listed in the classification catalog;

2. Academic papers, monographs and document reviews (if any) that can fully explain the clinical application value of the product published in the core journal;

3. Product innovation content;

4. Information or novelty search report issued by patent retrieval agency.

All application materials shall be in Chinese. For translation based on foreign language materials, the original text shall be provided at the same time.
service object Enterprise legal person; administrative organ
Work type Online processing; Express application
Times of arriving at the work site None
Handling process According to the Notice of the General Office of the General Administration of the People’s Republic of China on Regulating the Classification of Medical Devices (SFDBXG [2017] No. 127)

The Standards Management Center is responsible for organizing research and review on the application for classification and definition of imported and Hong Kong, Macao and Taiwan products, and the application for classification and definition issued by the provincial food and drug supervision and administration department.

After the standard management center organizes the review of the application for classification and definition of imported and Hong Kong, Macao and Taiwan products and the application for classification and definition issued by the provincial food and drug supervision and administration department with pre classification and definition opinions, if the standard management center believes that the medical devices belong to the “Classification Catalog” and other documents, the standard management center will directly inform the applicant of the classification and definition results in the classification and definition information system; For medical devices that are considered to be newly developed but not listed in the Classification Catalogue and other documents, the relevant professional groups of the Medical Device Classification Technical Committee shall be organized to study and propose technical suggestions for product classification, and the Standards Management Center shall inform the applicant in the classification definition information system after review. The Standards Management Center shall complete the classification confirmation within 20 working days from the date it accepts the classification definition application. If supplementary materials are needed, the applicant shall provide supplementary materials at one time within 30 working days according to the requirements of the notice of supplement and correction. If the applicant fails to submit the supplementary materials as required or fails to submit the supplementary materials within the time limit, the Standards Management Center will return the application. The time required for supplementary information and expert discussion is not included in the time limit.
Application materials (1) Application form for classification and definition;

(2) Product photos and/or product structure drawings;

(3) Product technical requirements and product specifications (draft);

(4) Certification materials for import listing (if any);

(5) Self guarantee statement of the authenticity of materials;

(6) Other materials related to product classification and definition;

(7) For the newly developed products that have not been listed in the Classification Catalog and other documents, the analysis and comparison with the relevant products listed at home and abroad, in the Classification Catalog or in the classification definition notification documents shall be submitted, and the judgment basis for the newly developed products that have not been listed in the classification catalog shall be stated;

(8) For newly developed products that have not been listed in the Classification Catalogue and other documents, academic papers, monographs and document summaries (if any) that can fully explain the clinical application value of the products published in the core journals shall be submitted;

(9) For newly developed products that have not been listed in the Classification Catalog and other documents, the innovation content of the products shall be submitted;

(10) For newly developed products that have not been listed in the Classification Catalogue and other documents, information or novelty search reports issued by patent retrieval agencies shall be submitted.
Other instructions According to the relevant requirements of the Notice of the General Office of the Food and Drug Administration on Matters Related to the Implementation of the Filing of Class I Medical Devices (SFDBXG [2014] No. 174), the medical devices listed in the Class I medical device product catalog and the Class I in vitro diagnostic reagents in the classification subcategory of in vitro diagnostic reagents, or the products classified as Class I medical devices, shall be filed according to the provisions of Announcement 26.

 

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