1. The Direction for the Application Form for Registration



1) All the contents shall be in both Chinese and English；



2) All the contents must be printed；



3) All the items must be completely filled in, and as for the vacant items, “/” shall

be used to show inapplicability；



4) The Name of Devices and Model, Name and Address of Manufacture must be

unanimously the same as the contents carried in the documents approved by

the government of the Country (Region) of Origin, and must be consistent with

the contents concerned carried in the test reports, operation instructions of the

product, and so on;



5) Any enterprise shall not set up the format for the Application Form for

Registration without authorization. The Application Form may be downloaded from

the website: http://www.sda.gov.cn/ylqjzc/setup.exe


2. As for the medical devices products manufactured by enterprises abroad, they

shall be re-registered 6 months prior to the date of expiry of the registration

certificates. Upon the application for re-registration, the following materials shall

be submitted:



1) The qualification certificate of the Applicant.



2) Copy of the original registration certificate.



3) The certificate recognized by the government of the Country (Region) of Origin to

authorize the products as medical devices to enter into the market of the

country.



4) Technical Standards of Products: Requirements of Safety and Technical

Performance of Products, and the corresponding experimental measures (the

standards of the products to be registered).



5) Operation manual of Products.



6) Type test Reports issued by the Medical Devices Quality Detection Agency

authorized by the State Drug Administration within the recent one year（applied

to Products of Class II and Class III）.



7) Product Quality Follow-up Reports.



The Product Quality Follow-UP Reports presented by the Manufacturer or after-

sale service agency after the application in the medical units of China.



8) The Product Quality Guaranty presented by the Manufacturer, to guarantee that

the quality of the products registered and sold in China are unanimously the

same as that of the identical products put into market in the Country (Region) of

Origin.



9) The certificate of commission for the After-Sale Service Agency designated in

China, the letter of commitment and business certificate of the commissioned

agency.



10) The Self-Guarantee Declaration on the authenticity of the materials submitted.



Note: The requirements for the documents listed in Items (1), (3), (4), (5), (6), (8), (9),

(10) shall be consistent with those carried in “the Initial Registration of Import Products”.

文章来源: State Food and Drug Administration,P.R.China