NMPA published “Extension of Pilot Program for Market Authorization Holder (MAH) system” on August 1, introducing the MAH system for 18 provinces including the booming med-tech markets of Beijing, Zhejiang, Jiangsu and Shandong. The policy is already in trial 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 (link HERE).
The document also clarified responsibilities for MAH and Contract Manufacturer:
- 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)
- 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.
As an NMPA qualified legal agent with offices in Beijing and Boston, China Med Device can represent overseas manufacturers for the complete product life cycle without their need to set up local entity in China. info@ChinaMedDevice.com
We can also help you establish GMP system, submit NMPA compliant manufacturing documents and conduct mock audit. For webinar on China GMP/ QMS, please click HERE.
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About ChinaMed Device, LLC
ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.