Overview:

On July of 2019, the National Medical Products Administration (NMPA) announced the implementation of the Pilot Program for Unique Device Identification (UDI) through “Notice of the State Drug Administration on Doing a Good Job in the First Batch of Issues Concerning the Implementation of the Unique Identification of Medical Devices” (2019 No. 72). However, due to COVID-19 the first batch of Medical Devices planned to go through implementation in October of 2020, will now be pushed back to January of 2021. 

Pilot Program Extension

During the pilot period, enterprises can upload, maintain and update relevant data to the medical device unique identification database, and all relevant parties can share application-related data through the unique identification database. Medical institutions can actively explore unique identification and medical device management, clinical applications, medical insurance settlement, etc. Convergence application of the field.

The pilot program trial period of the unique identification system with be extended to December 31, 2020.

First -Batch Implantation:

The first batch planned to be implemented will deal with high-risk  Medical Devices (Class III).  Examples of Medical devices included will be; middle ear prostheses, spinal intervertebral fixation/replacement systems, absorbable surgical hemostatic materials, penile prostheses, and implantable drug infusion devices. 

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.  To learn more, please contact us at  info@globalregulatorypartners.com

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