Beijing government starts to carry out the medical device MAH pilot work

On February 22nd, the State Council issued the official reply for ‘Comprehensively Promoting the Comprehensive Pilot Work Program for the Expansion and Opening of the Beijing Service Industry’ to Beijing government and the Ministry of Commerce. In the reply, State Council requires Beijing government to comprehensively optimize and improve government services, including medical device registration certificate and manufacturing license services.

In 2017, Shanghai was the first city to start China Medical Device Marketing Authorization Holder (MAH) pilot work, also called Medical Device Registrant System. It allows the registrants who have got medical device registration certificates to entrust medical device manufacturers for producing medical devices. It is the first time to separate the registration certificate and manufacturing license to two individuals. In 2018, Shenzhen and Tianjin successively started the pilot work. Now Beijing will begin to conduct the MAH pilot work. It allows the Beijing registrants to entrust the manufacturers in Beijing-Tianjin-Hebei region to produce medical devices.      

CIRS Comments

In the next 2 years, China medical device MAH system (Medical devices registrant system) will be established in ‘The Regulations for the Supervision and Administration of Medical Devices’. MAH system will be a common cooperation model between the registration certificate holders and medical device manufacturers. CIRS always provides one-stop professional and comprehensive services for you. If you are interested in marketing your medical device through the MAH system in the above cities, CIRS will help you solve all regulatory problems in the process.

For more details, please contact to us  

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