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Regulations and Guidelines

Product related Policis

1

Medical device Supervision and Administrative Regulations

2

Regulations on Clinical Trial of Medical Device

3

Medical Device Classification Rules

4

Regulations on Medical Device Instructions, Labels and Packages.

5

Medical Device Registration Administrative Measures

6

Administrative Measures for Registration of In Vitro Diagnostic Reagents (trial implementation)

7

Measures for Review of Medical Device Advertisement

8

Standards for Review and Publication of Medical Device Advertisement

9

Guidelines for Monitoring Adverse Events of Medical Device

10

Administrative Measures for Medical Device Recall

11

Administrative Measures for the Supervision and Management of Disposable Sterile Medical Device

12

List of National Key Supervised Medical Device(2009).

13

Review Procedure of Medical Device Registration  (for trial implementation)

14

Medical Device Clinical Trial Quality Management Standards (Draft for Solicitation of Comments)

Manufacturing companies related

1

Administrative Measures of Inspection of Medical Device Manufacturing Quality Management Standards

2

Implementation Details of Management Measures of Inspection of Medical Device Manufacturing Quality Management Standards for Sterile Medical Device

3

Implementation Details of Management Measures of Inspection of Medical Device Manufacturing Quality Management Standards for Implantable Medical Devices

4

Administrative Measures for Medical Device Production

5

Measures for the Evaluation of the Quality System of Manufacturers of Medical Device

 Trading companies related

1

Administrative Measures for the Licenses for Medical Device Operations

2

Regulations on Quality Management of Medical Device Business Operation (for comments collecting)