Notice of Shanghai Municipality on Medical Appliance Clinical Test

[2008-12-23 16:54:10]

Processing Authority: Medical Appliance Registration Office under Shanghai Food and Drug Administration

Processing Procedures: Basic requirements for medical appliance clinical test:

1. The medical appliance clinical test shall be conducted in the state-recognized drug clinical test bases. Under the prerequisite of assuring that the medical appliance clinical test is conducted subject to the Regulations on Medical Appliance Clinical Tests, any and all of drug clinical test bases can conduct various medical appliance products' clinical tests matching their own clinical business capabilities.

2. The implementer of the medical appliance clinical test shall, upon passing the review of the standard for to-be-registered product and form test of the very product, present the report of the standard for to-be-registered product and form test of the very product to Acceptance Window of Shanghai Drug and Medical Appliance Review and Assessment Center. Shanghai Food and Drug Administration shall, within 5 working days upon confirmation of acceptance and meeting requirements, issue the Certificate of Medical Appliance for use in Clinical Test.

3. The medical appliance clinical test can be implemented when the implementer of the medical appliance clinical test has obtained the Certificate of Medical Appliance for use in Clinical Test and the clinical test plan has been approved by the medical ethic committee. Any modification of the clinical test plan during the medical appliance clinical test shall be subject to approval by the medical ethic committee. The report of medical appliance clinical test shall be issued by the drug clinical test base.

4. The implementer of the medical appliance clinical test shall duly pack and label the medical appliances that are used for clinical test, and mark them as exclusively used for the clinical test.

5. The implementer of the medical appliance clinical test and the clinical test institute shall made the due use log of the very medical appliance, covering information on quantity, packaging, shipment, delivery, acceptance, distribution, recycling of the residue medical appliances after application, and destroying by melting or burning.

6. The clinical test plan shall define the logging method of the test information. The personnel of the clinical test shall ensure record the information observed and detected into the log correctly, and shall not alter the original log without due authorization.

7. The drug clinical test base in Shanghai shall, prior to conducting the medical appliance clinical test, report the name of the very product to undergo the medical appliance clinical test, the commencing and ending time of the very clinical test, and the name of the implementer of the medical appliance clinical test to Acceptance Window of Shanghai Drug and Medical Appliance Review and Assessment Center for record filing subject to requirements of the Form of Record Filing of Medical Appliance Clinical Test in Shanghai.

8. The implementer of the medical appliance clinical test shall, in order to ensuring the quality of the medical appliance clinical test and subject to the Regulations on Medical Appliance Clinical Test and the applicable clinical test contract, monitor the process of the medical appliance clinical test, record and save the result of the such monitoring, and be subject to supervision and inspection by the competent food and drug administration.

9. The report of the medical appliance clinical test is the important technical file for the process of reviewing registration of the very medical appliance. Such review shall be combined into the process of registrion.

Processing Address: Institute/authority of record filing of medical appliance clinical test:

Room 1108, Shuguang Tower, No. 189, Pu'an Road, Shanghai

Tel: 021-63870350、021-63855666-130

Authority of technical review of registration of medical appliances:

Acceptance Window of Shanghai Drug and Medical Appliance Review and Assessment Center:

Add: No. 1399. Huashan Road, Shanghai

Tel: 021-63855666

Processing Basis:

1. Regulations on Supervision and Administration of Medical Appliances under No. 276 Order of State Council;

2. Rules of Classification of Medical Appliances under No. 15 Order of State Food and Drug Administration;

3. Measures for Administration of Registration of Medical Appliances under No. 16 Order of State Food and Drug Administration; and

4. Regulations for Clinical Tests of Medical Appliances under No. 5 Order of State Food and Drug Administration;

Processing Time: Mondays through Thursdays: 9:00~11:30 and 13:30~16:30

Fridays: 9:00~11:30

Source: 上海市人民政府

Keywords:Quality Supervision

GACC Announcement No.56, 2014 on Cross-Border E-Commerce Trade Supervision (2014-08-05)
China Joint Announcement No.1851, 2014 on Precursor Chemicals “1-Phenyl-2-bromo-1-propanone” & “3-oxo-2-phenylbutyronitrile” Supervision (2014-06-24)
GACC Decree No.208 on Supervising Pingtan Experimental Area (2013-07-23)
Measuring Instrument Administration to be Strengthened (2009-12-17)
Chinese Insurance Regulator Stresses Supervision on Insurance Investment (2009-11-16)
Liu Mingkang: China and the US will Deepen Cooperation of Cross-border Supervisi (2009-08-04)
The National Standard for the General Rule for Enterprises Quality Credit Rating (2009-06-18)
Chinese Gov't Pledges Better Quality Supervision over Farm Products (2009-02-02)
Chinese Gov't Pledges Better Quality Supervision over Farm Products (2009-02-02)
[Imports Management ] General Administration of Quality Supervision, Inspection (2009-01-20)

Partners: China Customs | China Customs Statistics | China International E-Commerce | Customs-info