china Medical Devices INformation Network—

　　If you were submitting registration of imported product for the fist time, you may submit electronically.
　　The period of validity for product registration certificate after submission by overseas enterprises is 4 years. Submission for registration again should be made at 6 months before expiry of validity date of the registration certificate for medical devices made by overseas enterprises.
The departments related with such product registration include: Acceptance Office of State Food and Drug Administration, Technological Evaluation Center for Medical Devices, Division of Registration of Medical Device Department, and various related inspection centers.
A.Data required in submission
The submission data required for overseas medical device registration are:
(1) Application form for registration of overseas medical device;
(2) Qualification certificate of medical device production enterprise;
(3) A copy of applicant’s business license and a proxy for registration entrusted by the production enterprise.
(4) Documents proving that the product can enter a certain country (or region) as medical device approved or accepted by the medical device competent departments of overseas governments;
(5) Applicable product standard and explanations
For those adopting China national standard /professional standard as applicable standard of their product, the texts of the adopted China national standard/professional standard should be submitted; registered product standard should be signed and stamped by the production enterprise or its agent in China, or signed and stamped by the unit committed to draft the standard by the production enterprise. In the proxy of production enterprise committed to draft the standard should clearly indicate, “The production enterprise is responsible for the product quality ”.
The production enterprise should submit a statement that the product applied conforms to China national standard/professional standard, and a statement that the production enterprise would undertake the quality responsibility after sales, as well as remarks on the model and specification division of the related product.
The words “signed and stamped” here denote: stamp of the organization of enterprise, or signature of its legal representative or person in charge, or signature plus stamp (The implication will be the same when concerned with overseas medical devices below);
(6) Specification sheet for medical device
Specification sheets for Class II and Class III medical device should be signed and stamped by the production enterprise or its representative in China, Specification sheet for Class I products may not be signed or stamped.
(7) Inspection report on product registration given by medical device inspection organizations (applicable to Class II and Class III medical devices):
For medical devices that need to perform clinical tests, inspection report given by medical device inspection organization within half year before starting clinical test should be submitted. For those need not to perform clinical test, inspection report given by medical device inspection organization within one year before acceptance for registration should be submitted.
For those implementing Article 11, Article 12, Article 13 and Article 14 of this Method, the corresponding explanatory documents should be submitted;
For those implementing Article 15, the production enterprise should propose postponing of inspection application. In application, it should be guaranteed that registration inspection must be completed before the first set of the product is put into use in China.
(8) Clinical test data for medical devices (For the ways of specific submission, please see the Appendix 12 of this Method);
(9) Product quality warranty given by production enterprise:
It should be warranted that the product registered, sold and used in China is completely consistent with the quality of same product approved for marketing by medical device competent department of overseas government.
(10) Proxy of production enterprise to the assigned agent in China, written promise of agent, and business license or organization registration certificate:
The contents of the promise promised by the agent should be consistent with the matters entrusted in the proxy. The agent must also promise in his promise to be responsible for reporting adverse event of the medical device, and be responsible to contact with departments of (Food) Drug Administration;
(11) Proxy for assigned post sales service in China, written promise and quality certification documents of the entrusted organization:
Proxy for post sales service should be given by production enterprise, and the proxy should bear the name of the product. In multi-layer proxies, entrusted organizations of each layer must provide approved documents of production enterprise.
The contents promised by written promise of the entrusted enterprise should be consistent with the matters entrusted in the proxy.
The qualification certificate document of post sales service is business license (in its management contents should contain corresponding technical service items) or the registration certificate of the organization in China of the production enterprise.
(12) Self-guarantee statement on reality of the data submitted:
Should be given by production enterprise or its agency in China. In the statement should include a list of the data submitted, and a written promise of undertaking legal responsibility by the production enterprise.

All above documents should have Chinese versions. The testimonial documents in Item (2) and Item (4) of this Appendix may be submitted in copies, but should be signed and stamped by the original approval organization, or notarized by local notarizing organization. Unless otherwise stipulated, other documents of this Appendix should be submitted in original copies signed and stamped by the production enterprise, or its Chinese Office or Agency.

Requirements for the submission data on registration again of overseas medical devices
(1) Application form for registration of overseas medical devices;
(2) Qualification certificate of medical devices production;
(3) Original registration certificate of medical devices:
For the conditions of Chapter 5, Article 33, submit a copy of original registration certificate of medical devices. For the conditions of Chapter 5, Article 34 and Article 35, should submit the original copy of the original registration certificate of medical device;
(4) The certification documents of the product approved or accepted to enter the country (region) as medical device by overseas government medical device competent department;
(5) Applicable product standard and explanations
For those adopting China national standard/professional standard as applicable standard of their product, the texts of the adopted China national standard or professional standard should be submitted; registered product standard should be signed and stamped by the production enterprise or its agency in China, or signed and stamped by the unit which is entrusted to draft the standard by the production enterprise. The proxy of production enterprise in entrusting to draft the standard should clearly indicate, “The production enterprise is responsible for the product quality ”.
The production enterprise should submit a statement that the product applied conforms to China national standard/ professional standard, and a statement that the production enterprise would undertake the quality responsibility after sales, as well as remarks on the models and specification division of the related products;
(6) Specification sheet for medical device
Specification sheets for Class II and Class III medical device should be signed and stamped by the production enterprise or its representative in China. Specification sheet for Class I products may not be signed or stamped;
(7) Inspection report on product registration given by medical device inspection organizations (applicable to Class II and Class III medical devices):
For medical devices that need to perform clinical tests, inspection report given by medical device inspection organization within half year before starting clinical test should be submitted. For those need not to perform clinical test, inspection report given by medical device inspection organization within one year before acceptance for registration should be submitted.
For those implementing Article 11, Article 12, Article 13 and Article 14 of this Method, corresponding explanatory documents should be submitted.
For those implementing Article 10, Item 2 of《Regulations for inspection of imported medical device registration》, the corresponding approval document should be submitted;
(8) Follow-up report for product quality:
Follow-up report on the product quality after use by Chinese medical institutions given by the representative of production enterprise should include remarks on monitoring conditions of adverse events of the medical device;
(9) Product quality warranty given by production enterprise:
It should be warranted that the product registered, sold and used in China is completely consistent with the quality of same product approved for marketing by medical device competent department of overseas government.
(10) Proxy of production enterprise to the assigned agent in China, written promise of the agent, and business license or organization registration certificate:
The contents of the promise promised by the agent should be consistent with the matters entrusted in the proxy. The agent must also promise in his promise to be responsible for reporting adverse event of the medical device, and be responsible to contact with departments of (Food) Drug Administration;
(11) Proxy for assigned post sales service in China, written promise and qualification testimonial documents of the entrusted organization:
Proxy for post sales service should be given by production enterprise, and the proxy should bear the name of the product. In multi-layer proxies, entrusted organizations of each layer must provide approved documents of production enterprise.
The contents promised by written promise of the entrusted enterprise should be consistent with the matters entrusted in the proxy.
The qualification testimonial document of post sales service is business license (in its management contents should contain corresponding technical service items) or the registration certificate of the organization in China of the production enterprise;
(12) Those belonging to the conditions of Article 34 of this Method, should submit remarks and testimonial document on the corresponding conditions
(13) Self-guarantee statement on reality of the data submitted:
Should be given by production enterprise or its agency in China. In the statement should include a list of the data submitted, and a written promise of undertaking legal responsibility by the production enterprise.

Requirements for the first time registration submission of Class I overseas medical devices which has not been granted overseas medical device marketing approval

(1) Application form for registration of overseas medical devices;
(2) Qualification certificate of the production enterprise of medical devices;
(3) Applicable product standard and explanations
For those adopting China national standard/professional standard as applicable standard of their products, the texts of the adopted China national standard or professional standard should be submitted; the registered product standard should be signed and stamped by the production enterprise or its agency in China, or signed and stamped by the unit which is entrusted to draft the standard by the production enterprise. The proxy of production enterprise in entrusting to draft the standard should clearly indicate, “The production enterprise is responsible for the product quality”.
The production enterprise should submit a statement that the product applied conforms to China national standard/ professional standard, and a statement that the production enterprise would undertake responsibility of the product quality after sales, as well as remarks on the models and specification division of the related products;
(4) Inspection report on all specifications of the product;
(5) Remarks on the present resource conditions of the product and the ability in quality control (including inspection means) of the production enterprise;
(6) Specification sheet of the medical device (may not be signed and stamped);
(7) Proxy of production enterprise to the assigned agent in China, written promise of the agent, and business license or organization registration certificate:
The contents of the promise promised by the agent should be consistent with the matters entrusted in the proxy. The agent must also promise in his promise to be responsible for reporting adverse event of the medical device, and be responsible to contact with departments of (Food) Drug Administration;
(8) Proxy for assigned post sales service in China, written promise and qualification testimonial documents of the entrusted organization:
Proxy for post sales service should be given by production enterprise, and the proxy should bear the name of the product. In multi-layer proxies, entrusted organizations of each layer must provide approved documents of production enterprise.
The contents promised by written promise of the entrusted enterprise should be consistent with the matters entrusted in the proxy.
The qualification testimonial document of post sales service is business license (in its management contents should contain corresponding technical service items) or the registration certificate of the organization in China of the production enterprise;
(9) Self-guarantee statement on reality of the data submitted:
Should be given by production enterprise or its agency in China. In the statement should include a list of the data submitted, and a written promise of undertaking legal responsibility by the production enterprise.

All above documents should have Chinese versions. The testimonial documents in Item (2) of this Appendix may be submitted in copies, but should be signed and stamped by the original approval organization, or notarized by local notarizing organization. Unless otherwise stipulated, other documents of this Appendix should be submitted in original copies signed and stamped by the production enterprise, or its Chinese Office or Agency.

Requirements for the first time registration submission of Class II and Class III overseas medical devices which have not been granted overseas medical device marketing approval

(1) Application form for registration of overseas medical devices;
(2) Qualification certificate of the production enterprise of medical devices;
(3) Report on product technology:
Should include at least the contents of technological indices or determinative basis of the main specification requirements, and others;
(4) Analysis report on safety profile;
Compile and organize according to requirements in the standard of YY0316《Risk analysis for medical devices》. Should include analysis on 5 aspects, namely, energy hazard, biological hazard, environmental hazard, hazard in related uses, and the hazards due to failure of functions, lack of careful maintenance or obsolescence and their corresponding preventive measures;
(5) Applicable product standard and remarks
For those adopting China national standard/professional standard as applicable standard of their product, the texts of the adopted China national standard/professional standard should be submitted; the registered product standard should be signed and stamped by the production enterprise or its agency in China, or signed and stamped by the unit which is entrusted to draft the standard by the production enterprise. The proxy of production enterprise entrusting to draft the standard should clearly indicate, “The production enterprise is responsible for the product quality”.
The production enterprise should submit a statement that the product applied conforms to China national standard/professional standard, and a statement that the production enterprise would undertake the quality responsibility after sales, as well as remarks on the models and specification division of the related products;
(6) Self-inspection report on product specification:
The items of self-inspection of product specification are the delivery inspection items stipulated in the standard of registered product, and should be signed by the chief inspector or the person responsible for chief inspection, and reviewer. For those implementing national standard and professional standard, the production enterprise should supplement self-determined delivery inspection items;
(7) Inspection report on product registration given by medical device inspection organizations
For medical devices that need to perform clinical tests, inspection report given by medical device inspection organization within half year before starting clinical test should be submitted. For those need not to perform clinical test, inspection report given by medical device inspection organization within one year before acceptance for registration should be submitted.
For those implementing Article 11, Article 12, Article 13 and Article 14 of this Method, corresponding explanatory documents should be submitted.
(8) Clinical test data for medical devices. (For the ways of specific submission, please see the Appendix 12 of this Method);
(9) Specification sheet of medical device (should be signed and stamped by the production enterprise or its Chinese agency);
(10) Valid testimonial documents for examination of the product production quality system (certification):
Should submit the report by State Food and Drug Administration on examination of the production quality system of the medical device to be submitted for registration;
(11) Proxy of the production enterprise to assigned agent in China, written promise of the agent, and business license or organization registration certificate:
The contents of the promise promised by the agent should be consistent with the matters entrusted in the proxy. The agent must also promise in his promise to be responsible for reporting adverse event of the medical device, and be responsible to contact with departments of (Food) Drug Administration;
(12) Proxy of the production enterprise for assigned post sales service in China, written promise and qualification testimonial documents of the organization entrusted:
Proxy for post sales service should be given by production enterprise, and the proxy should bear the name of the product. In multi-layer proxies, entrusted organizations of each layer must provide approved documents of production enterprise.
The contents promised by written promise of the entrusted enterprise should be consistent with the matters entrusted in the proxy.
The qualification testimonial document of post sales service is business license (Its management contents should contain corresponding technical service items) or the registration certificate of the organization in China of the production enterprise;　　
(13) Self-guarantee statement on reality of the data submitted:
Should be given by the production enterprise or its agency in China. In the statement should include a list of the data submitted, and a written promise of undertaking legal responsibility by the production enterprise.