Production of Class I medical devices is examined and approved, and granted production registration certificate by Drug Administration of government of the city set up with districts. The production enterprises of Class I medical devices within our national borders are directly approved for production registration. The period of validity is two years. Registration again should take please at 6 months before expiration of the period of validity for approved production registration. According to Document [1992] Jia Fei Zi No. 534〕, the maximum registration fee shoul not exceed 2000 Yuan.
1.Submission data
(A)Submission for registration
(1) Application form for registration of Class I medical devices made within our national borders;
(2) Qualification certificate of medical device production enterprise:
Business license copy;
(3) Applicable product standard and explanation:
For those adopting national standard, professional standard as the applicable standard of their product, the text of the adopted national standard or professional standard should be submitted; the registered product standard should be signed and stamped by the production enterprise.
The production enterprise should submit a statement that the product applied conforms to national standard or professional standard, a statement that the production enterprise will undertake the quality responsibility after marketing, as well as remarks on the model and specification division of related products.
The words “sign and stamp” here denote: sign and stamp of the enterprise, or signature of its legal representative or person in charge plus the stamp of the enterprise (The implication will be same below when concerned with domestic medical devices);
(4) Inspection report on all specifications of the product;
(5) Remarks on the present resource conditions and quality control ability (including inspection means) for the products of the enterprise;
(6) Specification sheet of the medical device;
(7) Self-guarantee statement on reality of the data filed:
Should include a list of the data filed, and a promise of the production enterprise to undertake legal responsibility.

(B)Registration again
(1) Application form for registration of medical device made within our national borders;
(2) Qualification certificate of medical device production enterprise:
Business license copy;
(3) The original certificate of medical device registration:
For those belonging to the conditions of Chapter 5, Article 33 of this Method, submit a copy of original certificate of medical device registration. For those belonging to Chapter 5, Article 34 and Article 35 of this Method, should submit the original copy of certificate of medical device registration;
(4) Applicable product standard and explanation:
For those adopting national standard, professional standard as the applicable standard of their product, should submit the text of the adopted national standard or professional standard; registered product standard should be signed and stamped by the production enterprise.
The production enterprise should submit a statement that the product applied conforms to national standard or professional standard, a statement that the production enterprise will undertake the quality responsibility after marketing, as well as remarks on the model and specification division of related products;
(5) Follow-up report on the product specifications;
(6) Specification sheet of the medical device;
(7) For those belonging to Chapter 5, Article 34 of the Method, should submit remarks and certification document on the corresponding conditions;
(8) Self-guarantee statement on reality of the data filed:
Should include a list of data filed and a promise of the production enterprise to undertake legal responsibility.