Applicants who apply for a license extension shall fill out and submit an application form within six months prior to the expiration date, submit the following documents and information, and pay the fee to the central competent authority for submission:
1. Original license.
2. Manufacture and free sale certificate of the country of origin, which is not required for those manufactured domestically.
3. Foreign original manufacturer authorization letter, which is not required for those manufactured domestically.
4. Document verifying that manufacturer conforms to the Medical Device Quality Management System Regulations.
5. For a license issued in accordance with the provisions of Paragraph 1 of Article 12, safety surveillance or post-approval study report shall be submitted.
6. Other documents and information designated by the central competent authority.
If the central competent authority finds that documents and information of the preceding paragraph are not ready such that corrections can be made, the central competent authority shall notify the applicant to make corrections within three months. Failure to make corrections by the designated deadline shall subject the application to rejection.

For those applying for a license extension of Class 1 medical device, the provisions of Article 5 shall apply mutatis mutandis to the submission of their documents and information.

Those that fail to apply for a license extension before the expiration date in accordance with the provisions of Article 17 shall re-apply for registration and market approval in accordance with Articles 5 and 6 for a license to be issued.
If the application is for a Class 2 or Class 3 medical device license and it is re-applied within six months after the expiration date of original license, the following documents and information shall be submitted without being subjected to the restrictions in the provisions of Article 6:
1. Business permit of the medical device firm.
2. Original license.
3. Originally approved labels, instructions, or packaging stamped with tally impression of the central competent authority.
4. Draft of labels, instructions, or packaging.
5. Manufacture and free sale certificate of the country of origin, which is not required for those manufactured domestically.
6. Foreign original manufacturer authorization letter, which is not required for those manufactured domestically.
7. Document verifying that manufacturer conforms to the Medical Device Quality Management System Regulations.
8. Other documents and information designated by the central competent authority.
After approval of the application set forth in Paragraph 1, the license is issued with a new number.