Current Version

Draft Version

1. General regulations

1. General regulations

1.1

All clinical trials, except for those being announced with no significant risks, need to be approved by the central competent authority (CCA) before initiating.

1.4 Terms and definitions

Add: Group of subjects that are easily harmed

2. Protection of the rights of the subjects

2. Sponsor of clinical trials

2.6

Pre-clinical data and report should include

(i) Design of the product

(ii) Safety and performance tests

(iii) Risk analysis

(iv) Other essential pre-clinical studies

2.7

Sponsors should update related information on the designated web page within 30 days after the approval of clinical trials.

Within thetrial period, sponsors should update their information regularly every June and December.

2.8

Sponsors should implement Investigator brochure, clinical trial protocol, subject consent form, and other related procedures or regulations.

2.12

If the clinical trial is conducted on multiple sites, an Investigator Chair should be appointed.

2.22

Sponsors should conserve all trial related documents and their updated versions until the completion of the trial or 3 years after data entry or the acquisition of certification.

2.24

If the clinical trial is launched by an investigator, all enforcement rules under this regulation that are related to sponsors apply to the investigator.

3. Planning of clinical trails

3. Site and Investigator of clinical trials

3.25

Before the trial, an evaluation report shall be established to assess the human resources, space, facilities, and equipment according to medical device characteristics.

3.27

Investigators should fulfill below requirements:

(i) Doctors with practising license and clinical experience for more than 5 years.

Clinical trials with no significant risks could be operated by medical professionals with certification and related experience for more than 5 years.

(ii) Within the past 6 years, received clinical related training courses for 30hrs, including at least 9hrs of medical device clinical trial and medical ethics courses, respectively.

(iii) Certificated with essential ability to operate medical devices.

(iv) For those under disciplinary action or violated clinical trial related regulations, under suspension for more than 1 month or revocation of license, are excluded from investigators.

3.28

Investigators should follow the clinical trial protocol strictly, except when there is an emergency. However, investigators should submit written reports within 7 days after the emergency treatment.

4. Execution of clinical trails

4. Ethics committee

4.39

Reviewing results should be in written form, with

(i) The name of the clinical trial

(ii) Date and versions of the protocol and other related documents

(iii) Sponsor, investigator, and trial site

(iv) Result of the review and its reason

(v) Date when the result was confirmed

5. Suspension, termination, and completion of clinical trails

5. Subject consent form

5.54

Subject consent form should include:

(Xii) The domestic registration status of the medical device.

5.56

Any fee paid to the subjects by sponsor or investigator should be stated in subject consent form.

6. Sponsor of clinical trails

6. Application, suspension, termination, and completion of clinical trails

6.66

Before the completion of the study report is approved or before the closing of the trial is approved, sponsor, site and investigator are not allowed to publish the results or propagate them. This includes interviews and news reports.

7. Investigator of clinical trails

7. Corresponding to adverse events

7.70

For multi-site clinical trials, sponsor should inform all investigators about serious adverse events in written notice, and make sure all committees are informed.

8. Supplement