Applicants who apply for a listing to manufacture or import medical devices shall list the following documents and information in the medical device listing system (hereinafter referred to as “the Listing System”) established by the central competent authority, upload relevant documents and information as stipulated in Appendix 5 and pay the fee to obtain a listing number:
1. Chinese and English product names.
2. Name of the medical device firm.
3. Name and address of the manufacturer.
4. Item name and number of the medical device classification.
5. Sterility condition of the medical device.
6. Status of the manufacturer in conforming to the Medical Device Quality Management System Regulations.
7. Other documents and information designated by the central competent authority.
The provisions of Article 4 shall apply mutatis mutandis to the product names of medical devices in the preceding paragraph.

• Appendix 5：Documents and information that shall be uploaded for an application for a listing to manufacture or import Class 1 medical devices.pdf

With the exception of Subparagraph 4, those that change the listing particulars of any subparagraph referred to in Paragraph 1 of the preceding article shall apply for the change in the Listing System and pay the fee.
For the aforementioned application of change, the previous Article shall apply mutatis mutandis for applicants to upload the documents and information.
Changes to name of the medical device firm referred to in Subparagraph 2 of Paragraph 1 of the preceding article shall be limited to those that do not involve transfer of rights.
Changes to item name and number of the medical device classification referred to in Subparagraph 4 of Paragraph 1 of the preceding article shall not apply for a listing change.

Those who have been listed for one full year shall file an annual declaration in the Listing System in October of each year, confirm the listing status of the following particulars, and pay the fee:
1. Chinese and English product names.
2. Name of the medical device firm.
3. Name and address of the manufacturer.
4. Item name and number of the medical device classification.
5. Status of the manufacturer in conforming to the Medical Device Quality Management System Regulations.
6. Sterility condition of the medical device.
7. Other documents and information designated by the central competent authority.

For those that have been listed directly in accordance with Paragraph 4 of Article 25 of the Act by the central competent authority, medical device firms shall file a declaration in accordance with the provisions of the preceding article after the expiration date of original license.