Case Study 25 : Change of Local Agent, License Renewal for a Class II Medical Device in China

Company Situation

The Client is US based medical device manufacturer for orthopedic products, consisting of a of a cranial remolding orthosis that is a class II medical device. The first version of the product has been already approved in china few years ago. The old device registration was performed by a local regulatory consultant.

GRP Solution

GRP has worked with several companies who had faced issues with their current local agent or distributors in China that are managing their licenses. Being a specialized regulatory affairs company, global standards for project management and highly client focused approach, GRP offered a transparent and seamless service to Client by transferring the license and becoming the Local Agent for Client, preparing the technical change dossier and putting together a plan for license renewal to be submitted 6 months prior to expiration of license as per NMPA requirements.

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China's NMPA

In China, the regulating Health Authority is  The National Medical Products Administration (NMPA) also formerly known as the China Food and Drug Administration or CFDA). The NMPA is a vice-ministerial-level administrative agency under the State Administration for Market Regulation (SAMR).