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Category: Resources

No. 7 Measures for Supervision and Administration of Medical Device Production

November 13, 2017

No.14 Guideline on Clinical Evaluation of Medical Devices

November 13, 2017

Number 25 Quality Management Specification for Medical Device Clinical Trials

November 13, 2017

Annex 2 to Number 133 Clinical Trial Exemption List for Class III Medical Device (Second Batch)

November 13, 2017

Annex 1 to Number 133 Clinical Trial Exemption List for Class II Medical Device (Second Batch)

November 13, 2017

No. 4 Provisions for Medical Device Registration

November 13, 2017

Number 650 Regulation on Supervisory Management of Medical Devices

November 13, 2017

No. 4 Provisions of Medical Device Registration

November 13, 2017

Number 4 Provisions of Medical Device Registration

November 13, 2017

Number 650 Regulations on Supervisory Management of Medical Devices

November 13, 2017

Requirements for Clinical Evaluation of IVD Exempted from Trial (Draft)

November 8, 2017

Basic Requirements for Clinical Evaluation Materials of IVD Exempted from Clinical Trial (Draft)

Using Chinese Name for Registrant or File Submitter of Imported Medical Devices

November 2, 2017

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