The clinical trial institution or the sponsor shall submit an application form and the following documents and information for applying for a clinical approval of medical devices:
1. Medical device business permit,
2. Proposal of the clinical investigation plan and its Chinese-language abstract,
3. Informed consent form,
4. Case report form,
5. Qualification certificate of the investigator and the clinical trial institution,
6. Evaluation report specified in Article 25,
7. Information and related documents for compensation available in the event of injury and loss arising from participation in the clinical trial,
8. Investigator’s Brochure, and
9. Preclinical information and instructions of the investigational medical device.
Clinical trial applications from clinical trial institutions need not include the document referred to in item 1 of preceding paragraph.

The following items shall be specified in the clinical investigation plan:
1. The title of the clinical trial;
2. The name and address of the sponsor;
3. The name of the clinical trial institution;
4. The name, title, and contact information of the investigator and the coinvestigator;
5. The purpose of clinical trial;
6. Clinical trial design;
7. Basic information about the investigational medical device,
8. Inclusion and exclusion criteria, recruitment method, and number of subjects;
9. Description of the process for obtaining informed consent;
10. Procedures for data-processing;
11. Statistical considerations;
12. Adverse events, adverse device effects, and medical device deficiencies;
13. Procedures for recording, reporting, and analyzing clinical investigation plan deviations; and
14. Criteria and arrangements for suspension or termination of the clinical trial.

The following items shall be specified in the Investigator’s Brochure:
1. General information of the investigational medical device,
2. Preclinical testing data that has been performed on the investigational medical device,
3. The relevant previous clinical trial data of the investigational medical device, and
4. Risk management of the investigational medical device.

In the case of clinical investigation plan amendments, the sponsor shall submit the application form and attach the following documents and information to the central competent authority:
1. Copies of previous official documents verifying approval from the central competent authority,
2. Documents and information from before and after the amendment, and
3. A list of changes in the clinical investigation plan to compare the content before and after the amendment.
The amendment can only be conducted after approval has been obtained from the Competent Authority.

During the term of clinical trial conduction, the sponsor, investigator, and clinical trial institution shall present status reports of clinical trial to the central competent authority.

After close-out or premature termination of the clinical trial, the sponsor shall produce and submit a clinical investigation report to the central competent authority for recordation.

In cases where a trial is suspended or prematurely terminated in accordance with Articles 21, 35, or 45 of the present Regulations or Article 39 of this Act, the sponsor shall immediately notify the clinical trial institution, the investigator, the IRB, and the central competent authority.
For clinical trials initiated by the investigator, the notification shall be conducted by the clinical trial institution.

Suspended clinical trials can only be resumed after approval has been obtained from the IRB and the central competent authority.

The sponsor, clinical trial institution, or investigator shall not publish or promote the results of the clinical trial before the final report is approved for reference or before project closure.
The restrictions on the publishing and promoting of results specified in the preceding paragraph shall not be circumvented by the sponsor, clinical trial institution, or investigator through interviews or reports.

For the clinical trial that do not involve significant risks specified in the Paragraph 1, Article 37 of this Act, the provisions of Articles 58 and 61–64 do not apply; the requirements for approval from the central competent authority as stipulated in Articles 4 and 65 do also not apply.