NMPA published "Extension of Pilot Program for Market Authorization Holder (MAH) system" on August 1, 2019, introducing the MAH system for 18 provinces including the booming med-tech markets of Beijing, Zhejiang, Jiangsu and Shandong. The policy is already in the place at three provinces, Shanghai, Guangdong and Tianjin.
The MAH system has major implications for the developers who have limited manufacturing capabilities. Companies that register devices do not have to be the manufacturers. They may commission one or multiple qualified contract manufacturing organization(s) to manufacture the approved medical devices.
On 5 January 2018, Shanghai became the first MAH piloting city. Later Tianjin and Guangdong were added to the trial list published by the China State Council last year.
The MAH system helps incentivize the medical device developers to focus on research and development, and it accelerates the marketing process of the device. The first device approved though the system was the portable ECG recorder. It only took 26 working days from filing acceptance to final approval.
The document also clarified responsibilities for MAH and Contract Manufacturer:
MAH:
- Legally responsible for product design, clinical trial, manufacturing, sales and post-sales, recall and adverse event reporting, etc;
- Sign Letter of Authorization and Quality Agreement with contract manufacturer(s), and clarify both responsibilities in Product Technical Requirement (PTR), quality assurance and dischargement;
- Conduct periodical GMP audit for conduct manufacturers;
- Ensure device traceability and conduct adverse event monitoring;
- Ensure data authenticity in clinical trial or clinical evaluation report (CER)
Contract Manufacturer:
- Perform obligations specified by "Medical Device Supervision and Administration Regulations", Letter of Authorization and Quality Agreement;
- Responsible for MAH on device quality;
- Report quality issues to provincial NMPA where it locates.
If you want to know more about MAH, or want to watch the recorded webinar I did on China GMP/ QMS, please email me at gpalma@ChinaMedDevice.com.
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------