NMPA published six guidelines in August 2021:
- Guideline for Safety and Effectiveness Evaluation of Medical Devices Using Nanomaterials Part 1: System Framework
- Guideline for Nomenclature of Nerve and Cardiovascular Surgical Instruments
- Guideline for Nomenclature of Medical Diagnostic and Monitoring Devices
- Registration Guideline for Artificial Ligaments (Draft)
- Registration Guideline for Disposable High-pressure Radiography Syringes and Accessories (Draft)
- Registration Guideline for High-strength Titanium Orthopedic Internal Fixation Implants (Draft)
The guidelines are prepared by the NMPA’s Center of Medical Device Evaluation (CMDE) and local testing centers. It is not legally binding but highly recommended by regulatory authorities.
For both renewals and new registrations, medical devices need to meet these new guidelines. Even if renewals (required every 5 years by the NMPA) have no changes, manufacturers still have to prove that the originally approved products can meet the new guidelines. As a result, approved products still need to go through local type testing to show that they are current with these new requirements.
China Med Device, LLC has test engineers at NMPA testing centers to help you assess and expedite your type testing needs and shorten your renewal or new approval time.