Applicants who apply for a license issued by the registration and market approval to manufacture or import medical devices shall submit documents and information in accordance with the provisions of Articles 5 and 6 and pay the fee to the central competent authority for submission.
To apply for the registration and market approval referred to in the preceding paragraph for items announced by the central competent authority, applicants shall follow the testing notice issued by the central competent authority, pay the testing fee by the designated deadline, and submit sufficient samples necessary for testing to conduct testing procedures. However, this does not apply to those exclusively for export.
Registration particulars for the license referred to in Paragraph 1 are as follows:
1. Chinese and English product names.
2. Name of the medical device firm.
3. Name and address of the medical device manufacturer.
4. Effectiveness, intended use, or indication.
5. Ingredients, materials, structures, specifications, or model number of the medical device.
6. Labels, instructions, or packaging.
7. Manufacturing license number.
8. Other registration particulars that have been designated by the central competent authority.

The product name of a medical device referred to in the preceding article shall comply with the following provisions:
1. It shall not use the medical device trademark or firm name of others. However, this shall not apply when said product has obtained the trademark or the use has been authorized.
2. It shall not be the same as or similar to the medical device product name of other firms, thereby causing confusion with the medical devices of other firms.
3. It shall not involve any false or exaggerated statements, or lead people to have improper association or confusion on the intended use and effectiveness of medical device.
4. The Chinese product name shall not contain any characters in other language or any numbers. However, this shall not apply when the central competent authority deems that they have direct meaning or the English trademark has special meaning.
5. The Chinese and English product names of medical devices exclusively for export shall not be the same as the Chinese and English product names of medical devices that are sold domestically.
The determination of medical device product names being the same or similar shall be decided based on the precedence of trademarks, company names, or other identifiable names.

For an application of registration and market approval to manufacture or import Class 1 medical devices, the documents and information that shall be submitted are specified in Appendix 1.
For the application set forth in the preceding paragraph, the central competent authority may waive approval of registration particulars specified in Subparagraphs 5 and 6 of Paragraph 3 of Article 3.

• Appendix 1： Documents and information that shall be submitted for an application of registration and market approval to manufacture or import Class 1 medical devices.pdf

For an application of registration and market approval to manufacture or import Class 2 or Class 3 medical devices, except as stipulated in the provisions of Paragraph 2 of Article 19, the documents and information that shall be submitted are specified in Appendix 2 and Appendix 3.
For the application set forth in the preceding paragraph, the central competent authority may waive approval of registration particulars specified in Subparagraphs 5 and 6 of Paragraph 3 of Article 3 if the products are exclusively for export.

• Appendix 2： Documents and information that shall be submitted for an application of registration and market approval to manufacture or import Class 2 or Class 3 medical devices.pdf
• Appendix 3：“Applicable Product Items for Class 2 Medical Device Product Comparison and Preclinical Test Data Conformity Statement”mentioned in Section 7 of the Instructions in Appendix 2.pdf

After receiving an application of registration and market approval, the central competent authority shall conduct a formality review of application documents and information.
If the formality review set forth in the preceding paragraph finds application documents and information are not ready such that corrections can be made, the central competent authority shall notify the applicant to make corrections within one month. Failure to make corrections by the designated deadline shall subject the application to rejection.

After completing the formality review set forth in the preceding article, the central competent authority shall conduct a substantial review.
If the substantial review set forth in the preceding paragraph finds application documents and information are not complete or sufficient 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.

If any of the following circumstances applies to an application, the applicant may submit supporting documents and information to apply for priority review with the central competent authority:
1. For use in the prevention, diagnosis, or treatment of life-threatening diseases or diseases causing severe disability, with no appropriate medication, medical device, or suitable alternative treatment available yet domestically.
2. For use in the prevention, diagnosis, or treatment of rare diseases as specified in Paragraph 1 of Article 3 of the Rare Disease and Orphan Drug Act.
3. Having received priority assistance in accordance with government policies, been subsidized for research and development from the central competent authority or other authority, and conducting or will be conducting clinical trial domestically to verify product safety and efficacy, or meeting the domestic public health or urgent medical needs.

If any of the following circumstances occurs in an application after substantial review, the application shall be disapproved:
1. Payment of the fee does not meet the provisions.
2. Documents and information submitted are not ready or are inconsistent with regard to the contents of application.
3. Testing procedures have not been conducted in accordance with the provisions or submitted samples have been found to be noncompliant after the testing.
4. The medical device under application is such that its risk of harming the health of human body is greater than the benefit.
5. Other circumstances that do not comply with the provisions of laws and regulations.

The central competent authority shall notify the applicant of the application review result; if a license is approved and issued, the applicant shall, within three months after the arrival date of the notice, pay the license fee and prepare labels, instructions, or packaging according to the approved content to the central competent authority in order to obtain the license.
If the applicant fails to obtain the license in accordance with the provisions of the preceding paragraph, the central competent authority may cancel its license.

If the preliminary determination made by the central competent authority with regard to an application is that the product has the effectiveness stated in the application, does not present any significant risks, and meets one of the following circumstances, the central competent authority may request the applicant to provide a plan to conduct safety surveillance or post-approval study. After review, a license with shorter validity period may be issued:
1. For use in the prevention, diagnosis, or treatment of life-threatening diseases or diseases causing severe disability, with no appropriate medication, medical device, or suitable alternative treatment available yet domestically.
2. Meeting the domestic public health or urgent medical needs.
3. Being innovative or novel and having significant clinical benefits, with the potential of being used to enhance or support medical diagnosis and treatment.
If the applicant fails to conduct safety surveillance or post-approval study in accordance with the plan referred to in the preceding paragraph, the central competent authority may cancel its license.