I. Project name: Domestic Medical Device Registration
II. Content of licensing: Renewal of registration for domestic IVD
III. Basis for implementation: "Regulations for Supervision and Administration of Medical Devices ", "Provisions for Medical Device Registration", "Provisions for Registration of IVD (Interim)"
IV. Fees: No charge
V. Quantity restrictions: No quantity limit for the licensing
VI. List of application documents
Data number (1) Application form of renewal of registration of domestic IVD;
Data number (2) Copies of the original "Medical Device Registration Certificate" and "Approvals for application of IVD changes" (if any);
Data number (3) Copy of enterprise’s production license and business license;
Data number (4) Statement for authenticity of the submitted documents issued by the applicant;
Data number (5) Summary report of product quality, clinical applications, cases of adverse events during the term of the relevant registration certificate;
Data number (6) Statement of whether changes occurred between the product for renewal of registration and the originally registered product;
Data number (7) QMS assessment report completed All the above certification shall be within the validity period of the registration certificate;
Data number (8) For renewal of all IVD products that acquired registration certificate of medical devices before June 1, 2007, the applicant shall also submit relevant technical information such as product brochures and registered product standards.
VII. Requirements for application dossier:
(I) General requirements for the dossier:
1. The dossier shall be bound into books.
2. The first page of the dossier is a list of application documents, which shall be arranged in order as per “General requirements”. Each document shall be separated by labeled slip sheets and marked with data item number.
3. The dossier shall be in one full copy (product standards and product package inserts shall be in duplicate).
4. All documents in the dossier compiled by the applicant or agent shall be printed in A4 size paper, the contents shall be complete, clear, without alteration. Documents issued by the Government and other agencies shall be provided at the original size, where the bound volumes shall not be split without authorization.
5. The copies of the documents shall be clear and consistent with the originals.
6. The contents of application document (application form, approvals for marketing, product standards, testing reports, and package inserts) shall be consistent. The trade name and English name, if any, shall be marked.
7. The application documents shall be in Chinese, and translated documents shall be accompanied with the originals.
8. Product name shall meet the nomenclature rules stipulated by the "Provisions for Registration of IVD (Interim)".
9. The electronic versions of the following registration document shall also be submitted:
(1) Application form
(2) Elaboration of product standards and preparation explanations (if involved);
(3) Package inserts (if involved).
The above electronic documents, except for the application forms, shall be WORD document without exception, which can be edited and modified.
(II) Specific requirements for application documents:
1. Application form of renewal of registration of domestic IVD;
2. The “electronic application software 2010 for medical devices (IVD) registration” can be downloaded from www.cfda.gov.cn;
3. All entries of the form shall be filled in accordance with the requirements described in the instructions;
4. For remission or exemption of clinical trials for rare disease, special diseases and other conditions, the applicant shall submit such an application along with the registration application documents, stating the reasons therein and provide relevant documentation.
5. Copies of the original "Medical Device Registration Certificate" and "Approvals for application of IVD changes" (if any);
6. Copies of the enterprise’s production license and business license;
(1) The applied product shall be within the scope of the production license;
(2) They are All the above certification shall be within the validity period.
4. Statement for authenticity of the submitted documents issued by the applicant;
(1) List of submitted documents
(2) The applicant’s commitment for legal liabilities.
5. Summary report of product quality, clinical applications, cases of adverse events during the term of the relevant registration certificate;
Shall be submitted and signed by the applicant.
6. Statement of whether changes occurred between the product for renewal of registration and the originally registered product;
Shall be submitted and signed by the applicant.
7. QMS assessment report completed All the above certification shall be within the validity period of the registration certificate;
(1) Application form for IVD production QMS assessment;
(2) IVD production QMS assessment report;
(3) The QMS assessment report of the following three categories of IVD shall be issued by CFDA Center for Food and Drug Control:
① Reagents related to pathogenic antigens, antibodies, nucleic acid and other testing;
② Reagents associated with blood and tissue typing;
③ Reagents associated with allergic reaction (allergen).
(4) The QMS assessment report of other III IVD shall be issued by drug administration departments of the provinces, autonomous regions and municipalities that the enterprises locate.
8. For renewal of all IVD products that acquired registration certificate of medical devices before June 1, 2007, the applicant shall also submit relevant technical information such as product brochures and registered product standards.
9. The application documents shall be signed and sealed by the applicant, except for otherwise instructed. "Signed and sealed" means: sealed by manufacturer, or signed by its legal representative, responsible person, plus corporate seal. The seal must be the manufacturer’s official seal, registration stamp shall not be used.
10. For renewal application in combination with requests of change, the applicant shall describe the situation and submit related application documents in accordance with the requirements for change.
VIII. Application process diagram:
IX. Approval procedures:
After the application is filed to the Administrative Acceptance Service Center, and the application dossier submitted is in accordance with the list in VI of this Notice, the format examination shall be conducted by the work staff of the Center in accordance with the "Notice on the issuance of the formats and requirements for IVD registration application dossier" (SFDA Department of medical device supervision  No.609). Where the application item is not subject to administrative approval according to law, a decision of non-acceptance shall be notified to the applicant immediately. Where the application item is not within the functions of the administrative authority, a decision of non-acceptance shall be made immediately, and the applicant shall be informed to launch the application to relevant administrative authority. Where in the application dossier, there are errors that can be corrected on the spot, the applicant shall be allowed to make the corrections on the spot. Where the application dossier is incomplete or does not meet the statutory format, the applicant shall be informed of all the supplements and amendments to be made once and for all on the spot or within five days. If the applicant is not informed within the above-mentioned period, the application shall be deemed as accepted from date of receipt of application materials. Where the application dossier is within the functions of the administrative authority, the application materials are complete and comply with the statutory format, or where the applicant has submitted all supplements and amendments in accordance with the requirements of the administrative authority, the application for administrative approval shall be accepted.
Once the application is accepted, Administrative Service Center shall deliver the application dossier to the CMDE for technical review, which includes product testing and expert review, and not exceed 60days. In case of any rectification is required after the expert review, the rectification time shall not be included in the time frame for licensing.
(III) Licensing decisions:
Upon receipt of the dossier after CMDE technical review, CFDA shall make a decision for registration within 30 days, and written explanations shall be made for rejection of registration.
Within 10 days from the date of decision making of administrative approval, CFDA Administrative Service Center shall deliver the decision to the applicants.
X. Commitment time frame:
The administrative licensing decision shall be made within 60 days from the date of acceptance.
XI. Authority of Implementation:
Implemented by: CFDA
Accepted at: CFDA Administrative Service Center
For alterations of registration and licensing items after the approval of IVD registration, the applicants shall apply for alterations to relevant drug administration departments. For alterations of registration items, the applicant shall apply for the changes within 30 days from the date of the change; for alterations of licensing items, the applicant shall apply for the changes and implement them after approval, if alterations of licensing items occur within six months before the expiry of the registration certificate, application for change can be made along with renewal of registration. If marketed products changed the basic reaction principle or analytical sensitivity index with a new clinical diagnostic significance, they shall be handled in accordance with the initial application for registration.
XIII. License validity and renewal:
Medical device registration certificate is valid for four years. The applicant shall apply for the renewal of registration to relevant drug administration departments within six months before the expiry of the registration certificate. If the production and sales of a product are still necessary after renewal of registration before the expiry of the registration certificate, the applicant shall apply in accordance with the procedures and requirements for initial registration.
XIV. Annual inspection or annual review of the license: None
XV. Institutions for inquiries and complaints:
Complaints: CFDA Bureau of Investigation and Enforcement, Department of Legal Affairs
Note: The time frame of this Notice counts on working days, excluding legal holidays