Various Technical Review Guidelines Updated

In July 2020, the CMDE (Center for Medical Device Evaluation) of NMPA (National Medical Products Administration) announced its plans to draft the technical review guidelines for the following medical devices:

• Recombinant Human Collagen
• Degradable Magnesium Metal Orthopedic Implants
• Additives Manufacturing of Polyetheretherketone Implants
• Biomaterial Implants for Bone Regeneration
• Titanium Orthopedic Implants
• Personalized Orthopedic and Dental Implants;
• Additive Manufacturing and Selective Laser Melting of Metallic Materials for Dental Restoration
• Additive Manufacturing of Orthopedic and Dental Implants
• Biocompatibile Orthopedic Implants
• Orthopedic Implants in Animal Experiments
• Metal Plates for Bone Fixation
• Artificial Ligament;
• Collagen Type I for Cartilage Repair
• Artificial Shoulder Joint Prosthesis System
• Nanomaterials Used in Medical Devices

Domestic and overseas manufacturers of the above products were invited to sign up and cooperate with the CMDE to provide any needed assistance.

Also in July 2020, the CMDE issued the technical review guidelines (draft) for the following medical devices, and launched the public consultation to solicit comments:

• Vision Screening Device
• Electronic Endoscope for the Upper Gastrointestinal Tract
• Test reagents for IgG or IgM antibodies against Parvovirus B19
• Test reagents for IgG or IgM antibodies against  Mycoplasma pneumoniae

By Jacky Li. Contact Cisema if you would like to learn more.