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Medical Devices
Examination and approval for changes of overseas medical device registration certificate
2013-12-05

I.Project name: initial registration of imported medical devices

II.Contents of licensing: Examination and approval for changes of overseas medical device registration certificate
(I)Changes of corporate name, no change in corporate entity;
(II)Changes of production enterprise’s registered address;
(III)Textual changes of production address;
(IV)Textual changes of product name and trade name;
(V)Textual changes of models and specifications;
(VI)Textual changes of the name or code of product standards
(VII)Agent change;
(VIII)After- sales service agencies changed.

III.Basis for implementation: "Regulations for Supervision and Administration of Medical Devices", "Provisions for Medical Device Registration"

IV.Fees: No charge

V.Quantity restrictions: No quantity limit for the licensing

VI.List of application documents:
(I)Changes of corporate name, no change in corporate entity;
Data number (1) Application form for changes/reissuance of Medical Device Registration Certificate;
Data number (2) The original registration certificates of medical devices;
Data number (3) new legal qualification certificates of the manufacturer;
Data number (4) New product standards (for principal standard changes);
Data number (5) Manufacturers explanations of the changes and related certifying documents
Data number (6) Self-assurance statement of authenticity of the dossiers submitted;
Data number (7) Statement of no-change of corresponding elements.

(II)Changes of the manufacturers’ registered addresses and textual changes of production addresses:
Data number (1) Application form for changes/reissuance of Medical Device Registration Certificate;
Data number (2) The original registration certificates of medical devices;
Data number (3) Manufacturers explanations of the changes and related certifying documents
Data number (4) A statement about the change of address issued by manufacturer;
Data number (5) Self-assurance statement of authenticity of the dossiers submitted;

(III)Textual changes of product name, trade name, models, specifications, and name or code of product standards:
Data number (1) Application form for changes/reissuance of Medical Device Registration Certificate;
Data number (2) The original registration certificates of medical devices;
Data number (3) New product standards;
Data number (4) Medical device manuals;
Data number (5) Manufacturers explanations of the changes and related certifying documents
Data number (6) Self-assurance statement of authenticity of the dossiers submitted;
Data number (7) Other issues.

(IV)Agent change;
Data number (1) Application form for changes/reissuance of Medical Device Registration Certificate;
Data number (2) The original registration certificates of medical devices;
Data number (3) A statement of change of agent issued by the manufacture;
Data number (4) letter of entrustment of the new agent after change issued by manufactures;
Data number (5) New agent's business license or registration certificate after the change;
Data number (6) A commitment for entrustment and corresponding responsibilities issued by the agent;
Data number (7) Self-assurance statement of authenticity of the dossiers submitted;

(V)After- sales service agencies changed.
Data number (1) Application form for changes/reissuance of Medical Device Registration Certificate;
Data number (2) The original registration certificates of medical devices;
Data number (3) A statement for change or addition of after-sales service institutions issued by manufacturer;
Data number (4) A entrustment letter to changed/ new after-sales service institutions from manufacturer;
Data number (5) A statement of handling and commitment of after- sales service for products sold issued by manufacturer;
Data number (6) business license or registration certificate of the changed/ new after- sales service institutions
Data number (7) Letter of service commitment issued by the changed/ new after-sales service institutions
Data number (8) Self-assurance statement of authenticity of the dossiers submitted;

VII.Requirements for application dossiers:
(I)General requirements for application dossiers:
1.The first page of the application dossiers shall be a directory of the application items, the order of which shall be arranged as per by Annex X of the "Provisions for Medical Device Registration". Each dossier shall have a cover page indicating the name of the product and the applicant, and the dossier title shall be marked at the upper right corner. The dossiers shall be distinguishable with clear markers, and the name and serial number of the dossier shall be indicated. The entire dossiers shall be bound into a book.
2.The application dossiers shall be in One set and printed on A4 paper, the content shall be complete, clear, and shall not be altered, the documents issued by the Government and other institutions shall be provided in the original size.
3.Copies of the dossiers should be clear.
4.The product names in various items (approvals for marketing, standards, test reports, manuals) of applications dossiers shall correspond with the names and substantial contents in the Application form. Trade name (if any) should be marked. The application dossiers shall be in Chinese, and translated dossiers shall be accompanied with the originals. Chinese signature or seal follows the format prescribed in [2004] Doc. No.499.

(II)Specific requirements for application dossiers:
1.Requirements for dossiers of application in which the entity of the manufacturer did not change, but corporate name changed:
(1)Application form for changes/reissuance of Medical Device Registration Certificate;
①Medical device registration application form and the "2010 Electronic medical devices (IVD) application software (including manuals) "can be downloaded at www.cfda.gov.cn;
②Medical device registration application form is one of the important data for registration application, therefore the items shall comply with the requirements of instructions.
(2)Original registration certificate for medical devices (the applicant shall submit a copy while applying for changes, and return the original copy while receiving new certificate)
(3)new legal qualification certificates of the manufacturer;
(4)New product standards (for principal standard changes);
①Two copies;
②Two copies of statements on consistency of standards
(5)Manufacturers explanations of the changes and related certifying documents
(6)Self-assurance statement of authenticity of the dossiers submitted;
①Issued, signed and sealed by the manufacturer or its representative office in China, and notarized in the manufacturer’s country(region);
②The Statement should submit a list of dossiers;
③Including a commitment to legal liability.
(7)Statement of no-change of corresponding elements.
The manufacturer shall submit a statement of no change in production address, production conditions, product standards and other related elements.
2.Requirements for dossiers of application with changes in the manufacturers registered address and textual changes of production address:
(1)Application form for changes/reissuance of Medical Device Registration Certificate;
①Medical device registration application form and the "2010 Electronic medical devices (IVD) application software (including manuals) "can be downloaded at www.cfda.gov.cn;
②Medical device registration application form is one of the important data for registration application, therefore the items shall comply with the requirements of instructions.
(2)Original registration certificate for medical devices (the applicant shall submit a copy while applying for changes, and return the original copy while receiving new certificate)
(3)Manufacturers explanations of the changes and related certifying documents
(4)A statement about the change of address issued by manufacturer;
(5)Self-assurance statement of authenticity of the dossiers submitted;
①Issued, signed and sealed by the manufacturer or its representative office in China, and notarized in the manufacturer’s country(region);
②The Statement should submit a list of dossiers;
③Including a commitment to legal liability.
3.Textual changes of product name, trade name, models, specifications, and name or code of product standards:
(1)Application form for changes/reissuance of Medical Device Registration Certificate;
①Medical device registration application form and the "2010 Electronic medical devices (IVD) application software (including manuals) "can be downloaded at www.cfda.gov.cn;
②Medical device registration application form is one of the important data for registration application, therefore the items shall comply with the requirements of instructions.
(2)Original registration certificate for medical devices (the applicant shall submit a copy while applying for changes, and return the original copy while receiving new certificate)
(3)New product standards;
①Two copies;
②Two copies of statements on consistency of standards
(4)Medical device manuals;
(5)Manufacturers explanations of the changes and related certifying documents
(6)Self-assurance statement of authenticity of the dossiers submitted;
①Issued, signed and sealed by the manufacturer or its representative office in China, and notarized in the manufacturer’s country(region);
②The Statement should submit a list of dossiers;
③Including a commitment to legal liability.
(7)Others
①For textual changes of the models and specifications, the manufacturer shall submit a statement claiming liability for consistency of the product before and after the change.
②If the product before the change has obtained certificates for marketing approval issued by overseas medical device regulatory authorities, the applicant shall also provide certificates for marketing approval for the product after the change; If the product before the change are marketed after the manufacturer issued a Statement of Conformity, such statement shall also be submitted for the product after the change.
4.Requirements for application dossiers submitted by changed agents:
(1)Application form for changes/reissuance of Medical Device Registration Certificate;
①Medical device registration application form and the "2010 Electronic medical devices (IVD) application software (including manuals) "can be downloaded at www.cfda.gov.cn;
②Medical device registration application form is one of the important data for registration application, therefore the items shall comply with the requirements of instructions.
(2)Original registration certificate for medical devices (the applicant shall submit a copy while applying for changes, and return the original copy while receiving new certificate)
(3)A statement of change of agent issued by the manufacture;
(4)letter of entrustment of the new agent after change issued by manufactures;
Shall be signed and sealed by the manufacturers, and notarized in their country (region).
(5)New agent's business license or registration certificate after the change;
(6)A commitment for entrustment and corresponding responsibilities issued by the agent;
(7)Self-assurance statement of authenticity of the dossiers submitted;
①Issued, signed and sealed by the manufacturer or its representative office in China, and notarized in the manufacturer’s country(region);
②The Statement should submit a list of dossiers;
③Including a commitment to legal liability.
5.Requirements for application dossiers when the sales service institutions changed
(1)Application form for changes/reissuance of Medical Device Registration Certificate;
①Medical device registration application form and the "2010 Electronic medical devices (IVD) application software (including manuals) "can be downloaded at www.cfda.gov.cn;
②Medical device registration application form is one of the important data for registration application, therefore the items shall comply with the requirements of instructions.
(2)Original registration certificate for medical devices (the applicant shall submit a copy while applying for changes, and return the original copy while receiving new certificate)
(3)A statement for change or addition of after-sales service institutions issued by manufacturer;
(4)A entrustment letter to changed/ new after-sales service institutions from manufacturer;
(5)A statement of handling and commitment of after- sales service for products sold issued by manufacturer;
(6)business license or registration certificate of the changed/ new after- sales service institutions
(7)Letter of service commitment issued by the changed/ new after-sales service institutions
(8)Self-assurance statement of authenticity of the dossiers submitted;
①Issued, signed and sealed by the manufacturer or its representative office in China, and notarized in the manufacturer’s country(region);
②The Statement should submit a list of dossiers;
③Including a commitment to legal liability.

VIII.Application process diagram:


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 according to the requirements of the "Acceptance standards for domestic Class III and overseas medical device registration application dossiers"(SFDA Department of medical device supervision [2005] No. 111). 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)Licensing decisions:
After accepting the application, Administrative Service Center shall deliver the application dossiers 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.

(III)Delivery:
Within 10 days from the date of decision making of administrative examination and 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:
If any content listed in medical device registration certificate changes, the certificate holder shall, within 30 days from the date of change, apply for changes procedures or renew of registration.

XIII.License validity and renewal:
The expiry date of the medical device registration certificate after the change shall be the same as that recorded in the original certificate, and renew of registration shall be applied after expiration.

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 TIPS counts on working days, excluding legal holidays

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