First Registration

1． Application form for Registration of Import Medical Device
2． Legal Qualification certification for medical device manufacturing enterprise.
3． Qualification Certification of applicant.
4.Document proving that the government in the country of origin (or regions such as the European Community) has approved or recognized the product to be sold as medical device in the market of that country or region.
5.Product technical specifications which refer to the requirements for safety and technical functions of the product to registered and the corresponding testing methods.
6.Product instructions for use.
7.Test report issued within 1 year before the registration application by a test center recognized by the State Drug Administration.
8.Medical device clinical trials report.
9.Product Quality Guarantee issued by the manufacturer certifying that the quality of the product to be registered for sale in China is exactly the same as that of the product marketed in the country (region) of origin.
10.Letter of Authorization for designated aster-sales service agency in China and Letter of Promise and business license of the authorized agency.
11.Self-declaration by the enterprise to guarantee the truthfulness of the documentation submitted.