CMO of medical devices will become a hot spot as “separation of certificate and license” is promoted nationwide

The first official document of MAH system is No.44 document issued by the State Council in August 2015 on the reform of drug and medical device review and approval system. It is clear that the binding mode of drug marketing license and production license should be unbound in the past. In November of the same year, the drug MAH system began to be piloted in ten provinces and cities across the country, and the “amendment to the drug administration law of the people’s Republic of China (Draft for comments)” published by CFDA in October 2017 finally clearly released the signal to be implemented nationwide.

Mah greatly mobilized the enthusiasm of drug manufacturers in research and development, which spread to the medical device industry.