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:
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 device. £¨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 reapplication is required by the government of the Country of Origin, the enterprise shall give a statement, and provide the following certificates:
¢ÙThe free sale certificate issued by the government or
¢Úthe certificate to the foreign government and
¢Ûthe enterprise self-guarantee declaration in conformance with the provisions concerned of local regulations
2)In case of no document issued by the government of Country of Origin to authorize the medical devices to be put into market
(1) If the products shall be regulated as medical devices in the Country of Origin, but they have not been authorized by the government of Country of Origin to be put into market, the Standards of the Products to be Registered authorized by the competent department shall be submitted in case of Products of Class II or Class III, the full performance test report, Clinical Trial Reports, risk analysis reports within the territory of China and other documents necessary for the registration of import products shall be submitted, subject to which, the application may be accepted and after the acceptance, the on-site inspection of the production quality system will be arranged.
(2) If the products shall be regulated as medical devices in the Country of Origin,but need not be authorized by the government of Country of Origin to put in the market because they are produced specifically for China , the first paragraph of this Article shall be applied.
(3) If the products fail to be regulated as medical devices in the Country of Origin but the Products are defined as medical devices in China in accordance with the definition of medical devices, the first paragr
