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Medical Devices
Notice on alterations of Domestic IVD
2013-12-05

I. Project name: Domestic Medical Device Registration

II. Content of licensing: Alterations of Domestic IVD
(I) Change of registration items:
1. Change of manufacturer Name;
2. Change of enterprise’s registered address;
(II) Change of licensed contents:
1. Changes in the major materials such as antigens and antibodies used in the production process;
2. Changes of testing conditions and reference values (or reference range),etc.;
3. Changes of items, indices and testing methods specified in the registered product standards;
4. Changes in the package inserts, such as change or add to package specifications and applicable models etc.;
5. Changes of the product storage conditions and/or expiration date;
6. Expansion of the clinical scope, such as increased clinical indications and clinical measurement sample types;
7. Changes of production address (substantive changes of production sites);
8. Other changes that may affect the safety and effectiveness of products.

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:
(I) Textual changes of the name of the manufacturer and the registered address
Data number (1) IVD Change Request Form;
Data number (2) Copies of the original "Medical Device Registration Certificate" and "Approvals for application of IVD changes" (if any);
Data number (3) Copies of the enterprise’s production license and business license;
Data number (4) A statement of authenticity of the documents submitted;
Data number (5) The applicant’s explanations for changes;
Data number (6) Product standards before and after the change (applicable to the textual changes of manufacturer names);
Data number (7) Package inserts before and after the change
Data number (8) Samples of packaging and labeling before and after the change.

(II) Changes in the major materials such as antigens and antibodies used in the production process, if their suppliers changed
Data number (1) IVD Change Request Form;
Data number (2) copies of the original "Medical Device Registration Certificate" and "Approvals for application of IVD changes" (if any);
Data number (3) Copies of the enterprise’s production license and business license;
Data number (4) A statement of authenticity of the documents submitted;
Data number (5) The applicant’s explanations for changes;
Data number (6) Research data for changes of antigens, antibodies and other major materials;
Data number (7) Analysis of performance evaluation data;
Data number (8) Clinical trials data
Data number (9) Product standard before and after the change
Data number (10) Package inserts before and after the change

Changes of testing conditions and reference values (or reference range),etc.;
Data number (1) IVD Change Request Form;
Data number (2) Copies of the original "Medical Device Registration Certificate" and "Approvals for application of IVD changes" (if any);
Data number (3) Copies of the enterprise’s production license and business license;
Data number (4) A statement of authenticity of the documents submitted;
Data number (5) The applicant’s explanations for changes;
Data number (6) Research data for changed testing conditions and determination of reference value (or reference range);
Data number (7) Clinical trials data
Data number (8) Product standard before and after the change
Data number (8) Package inserts before and after the change

(IV) Changes of the product storage conditions and/or validity periods
Data number (1) IVD Change Request Form;
Data number (2) copies of the original "Medical Device Registration Certificate" and "Approvals for application of IVD changes" (if any);
Data number (3) Copies of the enterprise’s production license and business license;
Data number (4) A statement of authenticity of the documents submitted;
Data number (5) The applicant’s explanations for changes;
Data number (6) product stability research data;
Data number (7) Product standard before and after the change
Data number (8) Package inserts before and after the change
Data number (9) Samples of packaging and labeling before and after the change.

(V) Changes that modify registered product standards, but does not reduce the effectiveness of the product
Data number (1) IVD Change Request Form;
Data number (2) copies of the original "Medical Device Registration Certificate" and "Approvals for application of IVD changes" (if any);
Data number (3) Copies of the enterprise’s production license and business license;
Data number (4) A statement of authenticity of the documents submitted;
Data number (5) The applicant’s explanations for changes;
Data number (6) Analysis of performance evaluation data;
Data number (7) Product standard before and after the change ;
Data number (8) Package inserts before and after the change

(VI) Changes of production address (substantive changes of production sites);
Data number (1) IVD Change Request Form;
Data number (2) Copies of the original "Medical Device Registration Certificate" and "Approvals for application of IVD changes" (if any);
Data number (3) Copies of the enterprise’s production license and business license;
Data number (4) A statement of authenticity of the documents submitted;
Data number (5) The applicant’s explanations for changes;
Data number (6) Research data for analytical performance evaluation of products produced in new production sites;
Data number (7) QMS assessment report conducted in new production sites;
Data number (8) Package inserts and packaging labels after the change.

(VII) Modification of the Chinese text of the package inserts and/or registered product standard, but not involving changes to the technical contents
Data number (1) IVD Change Request Form;
Data number (2) Copies of the original "Medical Device Registration Certificate" and "Approvals for application of IVD changes" (if any);
Data number (3) Copies of the enterprise’s production license and business license;
Data number (4) A statement of authenticity of the documents submitted;
Data number (5) The applicant’s explanations for changes;
Data number (6) Package inserts and/or product standards before and after the change;
Data number (7) The explanation of changes of the package inserts and/or registered product standards shall contain a comparative table of the changes.

Increase or change of the packaging specifications
Data number (1) IVD Change Request Form;
Data number (2) Copies of the original "Medical Device Registration Certificate" and "Approvals for application of IVD changes" (if any);
Data number (3) Copies of the enterprise’s production license and business license;
Data number (4) A statement of authenticity of the documents submitted;
Data number (5) The applicant’s explanations for changes;
Data number (6) Testing data of analytical performance evaluation of products with changed packaging specifications;
Data number (7) Product standard before and after the change
Data number (8) Package inserts before and after the change
Data number (9) Samples of packaging and labeling before and after the change (if involved).

(VX) Changes of add to new applicable models
Data number (1) IVD Change Request Form;
Data number (2) Copies of the original "Medical Device Registration Certificate" and "Approvals for application of IVD changes" (if any);
Data number (3) Copies of the enterprise’s production license and business license;
Data number (4) A statement of authenticity of the documents submitted;
Data number (5) The applicant’s explanations for changes;
Data number (6) Testing data of analytical performance evaluation of products with new applicable models;
Data number (7) Product standard before and after the change
Data number (8) Package inserts before and after the change
Data number (9) Samples of packaging and labeling before and after the change (if involved).

(X) Changes of increased clinical indications
Data number (1) IVD Change Request Form;
Data number (2) copies of the original "Medical Device Registration Certificate" and "Approvals for application of IVD changes" (if any);
Data number (3) Copies of the enterprise’s production license and business license;
Data number (4) A statement of authenticity of the documents submitted;
Data number (5) The applicant’s explanations for changes;
Data number (6) Product standard before and after the change
Data number (7) Package inserts before and after the change
Data number (8) Testing data of analytical performance evaluation of increased clinical indications;
Data number (8) Clinical trial data for increased clinical indications.

Changes of adding sample types for clinical measurement
Data number (1) IVD Change Request Form;
Data number (2) Copies of the original "Medical Device Registration Certificate" and "Approvals for application of IVD changes" (if any);
Data number (3) Copies of the enterprise’s production license and business license;
Data number (4) A statement of authenticity of the documents submitted;
Data number (5) The applicant’s explanations for changes;
Data number (6) Product standard before and after the change ;
Data number (6) Package inserts before and after the change ;
Data number (8) Comparative testing data of the approved sample type with the added sample type for clinical measurement.

(XII) Other changes that may affect the effectiveness of the product
Data number (1) IVD Change Request Form;
Data number (2) copies of the original "Medical Device Registration Certificate" and "Approvals for application of IVD changes" (if any);
Data number (3) Copies of the enterprise’s production license and business license;
Data number (4) A statement of authenticity of the documents submitted;
Data number (5) The applicant’s explanations for changes;
Data number (6) Testing data provided in accordance with changes.

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 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. IVD Change Request Form;
(1) The “electronic application software 2010 for medical devices (IVD) registration” 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 registration application documents, stating the reasons therein and provide relevant documentation.
2. Copies of the original "Medical Device Registration Certificate" and "Approvals for application of IVD changes" (if any);
3. 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. A statement of authenticity of the documents submitted;
(1) List of submitted documents;
(2) The applicant’s commitment for legal liabilities.
5. The application dossier 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.
6. If some testing data in the application dossier is provided by overseas study institutions, explanations about the data items, page numbers etc., and certifying documents that prove 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
7. While applying for change, the applicant shall provide the product standards and package insert before the change in full copy, and in duplicate after the change (if involved), and are required to submit electronic documents in WORD format, which can be edited and modified.

VIII. Application process diagram:

(I) Change of registration items:


(II) Change of licensed contents:

IX. Approval procedures:
(I) Acceptance:
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 [2007] 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.

(II) Review and licensing decisions
1. Change of registration items:
After accepting the application, Administrative Service Center shall deliver the application dossier to CFDA for administrative approval, CFDA shall make a decision for approval or disapproval within 20 days, for disapprovals, CFDA shall give reasons in writing.
2. Change of licensed contents:
After accepting the application, Administrative Service Center shall deliver the dossier to CMDE for technical review. After CMDE’s technical review, the application dossier shall be sent to CFDA for administrative approval, the latter shall decide approval or disapproval, and written explanations shall be made for disapprovals.

(III) Delivery:
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 20 days from the date of acceptance.

XI. Authority of Implementation:
Implemented by: CFDA
Accepted at: CFDA Administrative Service Center

XII. Changes:
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:
The validity of "Approval letter for IVD Changes" is the same as that of the original registration certificate, and renewal shall be applied upon expiry.

XIV. Annual inspection or annual review of the license: None

XV. Institutions for inquiries and complaints:
Inquiries: CFDA
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

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