Article 13 The application for registration or for the record of imported medical devices, the applicant or the filer should be registered or production address in the country (region) has been approved for sale.
The applicant or the filing of the applicant's place of registration or production address in the country (region) is not the product as a medical device management, the applicant or the filing of the applicant is required to provide the relevant documents, including the place of registration or production address in the country (region) to authorize the sale of the product on the market documents.