What is a medical device registration form?

The so-called medical device product registration form, that is, the medical device "copy", medical device registration certificate including registration form, generally recorded: the name of the manufacturer, enterprise registered address, production address, model specifications, product standards, product performance structure and composition, product scope of application products contraindications, etc. (This is the domestic medical device registration form). (This is the registration form for domestic medical devices).

In addition, the 2000 "Medical Device Registration Regulations" (has been abolished) provides (Chapter I, Article 4):

(1) the domestic enterprise production of medical devices registration certificate with "medical device product manufacturing approval form", and the certificate is used at the same time;

(2) foreign enterprises to apply for the registration of the product certificate is accompanied by the "medical device product registration", and the certificate is used at the same time. Registration Form", and the certificate used at the same time.

In summary, the registration form and manufacturing approval form are the same thing, are attached to the medical device product registration certificate.