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Regulatory Guide - Medical Devices - Initial registration of import products
Initial registration of import products
 
2011/7/4 9:20:24¡¡Source: ¡¡Hits:

A. The Direction for the Application Form of Registration
 
1. All the contents filled in shall be in both Chinese and English£»
 
2. Upon the application, the form shall 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 Manufacturer 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 manual 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
 
B. About the Application Documents
1. The certificate of the legal production qualification of the Manufacturer.
 
1) The certificate issued by the government agency of the Country (Region)of Origin to authorize the Manufacturer to engage in the production and distribution of medical devices£¨equivalent to the business certificate or manufacturing enterprise license£©.
 
2) The certificates may be submitted in the form of the copy thereof, subject to the seal by the original issuing agency or the notarization by the local notarization agency.
 
2. The qualification certificate of the applicant
 
1) Business certificate of the Applicant£»
 
2) The certificate of commission given by the Manufacturer to the agent for registration
 
3. The certificate recognized or approved by the government of the Country (Region) of Origin to authorize the products as medical devices to enter into the market of the country.
 
1)The certificate recognized or approved by the government of the Country (Region) of Origin to authorize the products as medical devices to enter into the market of the country.
 
(1) In case of any special authorization documents specified by the government of Country (Region) of Origin for medical devices to be put into the market of the Country (Region) of Origin, such formal authorization documents as 510 K or PMA of the U.S. FDA, and the CE certificate of the EU shall be submitted.
 
(2) In case of one of the following circumstances:
 
a. That no special authorization documents are required to handle by the government of the Country of Origin£»
 
b. That in case of any change to the Products on the basis of the Products specified in the original special authorization documents, due to the difference in the partition of registration elements, no re-application is r

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