Medical Device GMP Certification

Legal basis

• 1
  NMPA(CFDA) announcement on the issuance of medical equipment production quality control standards
• 2
  NMPA(CFDA) announcement on the implementation of the quality control standards for medical device production
• 3
  NMPA(CFDA) notification on the guidelines for the production quality control of medical devices and the guidelines for on-site inspection of custom-made dentures
• 4
  NMPA(CFDA) announcement on the release of medical instrument quality control regulations and appendix for IVD reagents
• 5
  NMPA(CFDA) announcement on the issuance of medical equipment quality control regulations appendix medical implants
• 6
  NMPA(CFDA) announcement on releasing the appendix of asepsis medical instruments for the quality control of medical devices

Medical Device GMP Certification

The required information

Refer to the local food and drug administration rules of the place where the enterprise is located