Discussion on the implementation path of medical device registrant system under the background of MAH

The background and development history of the medical device MAH system

With reference to the advantages of the drug MAH system in developed countries such as Europe and the United States, in August 2015, the State Council issued the "Opinions on Reforming the Drug and Medical Device Review and Approval System", proposing to promote the drug marketing authorizer system.

Figure 1 The development history of the medical device MAH system

According to public information

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The impact of the implementation of the medical device MAH system and development opportunities

Before the implementation of the medical device MAH system, medical device companies must apply for a product registration certificate before they can apply for a production license.

1.

The MAH system will effectively encourage the initiative, enthusiasm and creativity of R&D companies, researchers, and clinical institutions, and stimulate more R&D companies and researchers to engage in innovative R&D.

2.

According to the Firestone Creation database, as of March 13, 2021, there are 22,384 domestic medical device manufacturing and R&D enterprises, of which more than 90% are small and medium-sized enterprises, and less than 10% of enterprises above designated size.

The launch of the medical device MAH can effectively solve the problems of limited funds, compliance, lack of production personnel, and long new workshop cycles faced by start-ups in the early stage, allowing innovative R&D companies to focus on product development and do not need to obtain mass production after registration Too much financial and management energy is invested in manufacturing, and it can be quickly produced and marketed through OEM or outsourcing, shortening the listing cycle of enterprise products.

3.

The registrant system can avoid the situation of multiple licenses and multiple competitions for the same variety, and it will be more flexible for mergers and acquisitions and reorganizations of enterprises, and the cooperation model will also be more diverse.