The NMPA published “Guidelines Revisions for 22 Class II Medical Devices” on March 17, 2021. Feedback needs to be submitted by April 17, 2021.
It is responding to the “2021 Medical Device Guidelines Revisions Plan” released on February 9, 2021, in which 51 guidelines were affected. The revisions are aimed to facilitate manufacturers with local type testing and regulatory filling and make guidelines more consistent with the international counterparts.
Importance of Medical Device Guidelines March 2021
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 starting March 2021. 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.
The List of NMPA Medical Device Guidelines March 2021
22 devices include but not limited to the following:
- Registration Guideline on Fluorescence Immunochromatographic Analyzers
- Registration Guideline on Pepsinogen I/II Detection Reagent
- Registration Guideline on Prothrombin Time/Activated Partial Thromboplastin Time/thrombin Time/fibrinogen Detection Reagent
- Registration Guideline on Passive Surgical Device Product under Arthroscopy
- Registration Guideline on Orthodontic Filament
- Registration Guideline on Net Atomizers
- Registration Guideline on Low-temperature Gas Sterilizers
- Registration Guideline on Anesthesia Mask Products
- Registration Guideline on X-ray Imaging Equipment for Pediatric Applications
- Registration Guideline on Ultrasound Transcranial Doppler Blood Flow Analyzers
Gastroenterology / Urology
- Registration Guideline on Single-use Ureteral Introducer Sheaths
- Registration Guideline on Dispensable Minimal Invasive Fascial Closure Device
For the complete list please email info@ChinaMedDevice.com.
The NMPA medical device guidelines March 2021 are developed by different local testing centers. Email us to get the corresponding contacts.