Monthly NMPA (CFDA) News Roundup covers government announcement, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China.
Highest Decree of Medical Devices Revealed
New China NMPA Reform titled “Regulation on the Supervision and Administration of Medical Devices”, or Order 739, is released on March 16, 2021. It was adopted by the China State Council on December 22, 2020 and signed into law on March 16, 2021, with the effective date of June 1, 2021.
Compared with Order 680 released in May 2017, Order 739 formalized the responsibilities and accountabilities of Market Authorization Holders (MAHs) for the complete product life cycle, balancing clinical needs and risks, encouraging innovations, and imposing heavier penalties on violations for both companies and companies’ key individuals.
For our comprehensive review on the Decree, from MAH program, clinical exemptions to post-market surveillance, please click HERE.
Four Documents in Support of Order 739 Released
The NMPA provides four draft regulations, in support of the State Council “Regulation on the Supervision and Administration of Medical Devices”, Order 739, on March 26, 2021. Feedbacks need to be submitted by April 25, 2021. Click HERE for more information
2020 Adverse Events Report Released: Infusion, Protection and Monitoring Devices Had Most Complaints
NMPA issued 2020 Adverse Events Report on March 22, 2021, summarizing over 530,000 reports, 35.25% rise from the year before.
By device category, infusion, nursing, and protection equipment got most reports, standing for 42.26%, followed by diagnostic and monitoring equipment and physical therapy device. For more information with the top ten complained device categories, please click HERE
Intellectual Property: NMPA Finalizes Process for Submitting Master Files
NMPA issued Notice regarding Medical Device Master Files Register on March 12, 2021. The draft was published in January 2019.
Medical device master file in China is a technical document that owner of the file submits to NMPA Center of Medical Device Evaluation (CMDE) to authorize the applicant to use in the medical device registration but does not directly disclose the content to the applicant. Click HERE for more information
22 Class II Device Guidelines Ask for Feedback
CMDE published “Guidelines Revisions for Class II Medical Devices” on March 17, 2021, involving 22 medical devices. Click HERE for the complete list.
About China Med Device, LLC
China Med 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 legal agent with offices in Boston, Beijing and Hainan, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our regulatory services include strategy, registration, type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance. Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.