I. Project name: Domestic Medical Device Registration
II. Content of licensing: initial 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 domestic IVD registration;
Data number (2) Copy of enterprise’s production license and business license;
Data number (3) A statement of authenticity of the documents submitted;
Data number (4) Summary data
Data number (5) Package inserts；
Data number (6) Intended product standards and its preparation explanations;
Data number (7) Registration testing report;
Data number (8) Research data for major raw materials;
Data number (9) The research data for main production technology and reaction system;
Data number (10) Analysis of performance evaluation data;
Data number (11) Determination of reference value (reference range);
Data number (12) Stability research data;
Data number (13) Clinical trials data
Data number (14) Production and self-test records;
Data number (15) Sample of packaging and labeling;
Data number (16) Quality management system evaluation report.
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 are 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 document 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 insert) 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) Abstracts of the literature review, wherein: the intended use of the product (500 words or less), product description (200 words or less), biological safety explanations (100 words or less),summarizes and evaluation of the main findings (200 words or less) and others (200 words or less);
(3) Intended product standards and its preparation explanations;
(4) Package inserts
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 registration of domestic IVD;
(1) The “electronic application software 2010 for the registration of medical devices (IVD)” can be downloaded from www.cfda.gov.cn;
(2) All entries of the form shall be filled in accordance with the requirements described in the instructions;
(3) 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 application documents, stating the reasons therein and provide relevant documentation.
2. Copy of 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.
3. A statement of authenticity of the documents submitted;
(1) The list of the submitted documents shall be accompanied by a promise of the consistency between the "research data of major production processes and reaction system" with the QMS assessment data;
(2) The applicant’s commitment for legal liabilities.
4. Package inserts
(1) The format of the package inserts shall be in line with the "Guidelines for Compiling the Package Inserts of IVD ";
(2) Package inserts shall be in duplicate with a statement of mutual consistency.
5. Intended product standards and its preparation explanations;
(1) The intended product standards and the preparation explanations shall be in duplicate with a statement of mutual consistency;
(2) The format of intended product standards shall be in line with GB/T1.1.;
(3) If national standards or industry standards is adopted as product applicable standards, the applicant shall submit:
① A statement of the applied product’s compliance with national standards and industry standards;
② A statement of commitment for post-marketed product quality;
Explanations of the classification of product packaging specifications.
6. Registration testing report;
(1) Originals of registration testing reports issued by competent testing institutions accredited by CFDA;
(2) The packaging specifications of the testing product shall be within the range of the registration application;
(3) Testing type shall be registration testing;
(4) For Class III products, registration testing of three consecutive production sample batches shall be conducted.
7. Clinical trials data
(1) Class III products: the applicant shall carry out clinical trials in no less than three (including three) provincial health care institutions.
(2) Class II products: the applicant shall carry out clinical trials in no less than two (including two) provincial health care institutions.
(3) For special-purpose products, the applicant can conduct clinical trials in qualified municipal-level and above centers for disease control, specialized hospitals or inspection and quarantine institutions, detoxification center and other institutions.
(4) Clinical trial agreement: signed by clinical trial institutions and the applicant.
(5) Clinical trial protocol: signed and sealed by the primary leaders (signature), clinical trial organizations (seal), person and institution in charge of statistics, the applicant, and the ethics committee (leading unit).
(1) If the clinical trials aren’t subject to the consent of the Ethics Committee, the leading unit shall still provide a description of the ethical issues with signature.
(6) Clinical trial reports issued by the institutions, the cover of which shall include:
① Name of the product used in the clinical trial;
② Start and finish dates of clinical trials;
③ Signatures of all main person responsible for the clinical trials, the signature of clinical trials institution, the signature and seal of Statistics head and the stamp of the applicant;
③ The contact and contact information of the product registration applicant, the reporting date and the locations for archiving of original data.
(7) Summary report of the results of all clinical trials:
① The reports shall be completed by the leading unit or the applicant;
② The contents of the cover shall be the same as those of the clinical trial reports of various clinical trial institutions.
(8) Detailed information of clinical trials, including the results of all clinical trials, other testing methods or other basic information of diagnostic reagent products, such as testing methods, sources of diagnostic reagent products, package inserts and registration approvals and so on.
(9) The batch numbers of clinical trial samples must match with those used by the applicant for intended product standards testing, and the pre-clinical testing reports can be either the applicant’s self-test report, or testing report issued by other competent testing institutions entrusted by the applicant.
(10) For calibration products, quality control products, and reference solution etc., clinical trial data need not to be provided.
(11) The “seals” of clinical trial institutions mentioned in this section refers to the official seals of clinical trial institutions and/or competent departments responsible for the trials in clinical trial institutions.
8. Production and self-test records;
Provide copies of three consecutive batches production and self-test records.
9. Quality management system evaluation report.
(1) For application of initial registration of Class II & III IVD, the following documents shall be submitted:
① Application form for IVD production QMS assessment;
② IVD production QMS assessment report;
③ IVD development verification report form.
(2) For initial registration of products under existing QMS assessment report, the following documents shall be submitted:
① Application form for IVD production QMS assessment;
② Original IVD production QMS assessment report;
③ IVD development verification report form.
(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 Class II and III IVD shall be issued by drug administration departments of the provinces, autonomous regions and municipalities that the enterprises locate.
10. 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.
11. If some testing data in the application documents are provided by overseas study institutions, explanations about the data items, page numbers etc., and certifying documents proving that the institution has been legally registered overseas and notarized shall be provided. However, performance evaluation analysis data, stability studies, clinical trial data, production and self-test records must be generated by using products domestically produced by Chinese manufacturers.
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 90 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