Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in September 2021. These updates are presented by China Med Device, LLC, your partner in Chinese market access.
More Class II & III Medical Devices and IVDs Exempted from Clinical Trials
The NMPA released the “Catalog of Medical Devices and IVD Products Exempted from Clinical Trials” on September 18, 2021, which includes 1010 devices and 423 IVDs.
35 medical devices are added to the clinical trial exemptions list, including 16 Class III devices, and seven IVD reagents are exempted from clinical trial, including three Class III reagents. For full article please click HERE
Huge Changes Made on Hainan Policy: Faster Approval and Home Use Allowance
The Hainan Provincial NMPA, the Hainan Health Commission, and the Haikou Customs jointly issued the “Optimizing Regulatory Services to Support the High-Quality Development of Hainan Boao Medical Tourism Pioneer Zone” on September 15, 2021.
Significant changes have been made to facilitate the faster approval of medical devices in Hainan, such as qualification of medical institutes, online importation request, home-country device classification, faster approval, and home-use allowance. For our comprehensive analysis please click HERE
Is Clinical Trial Necessary for Your Device? NMPA Final Guideline Issued
NMPA published the “Guideline on Decision Making of Conducting Clinical Trial for Medical Devices” on September 28, 2021, directing manufacturers on how to decide if clinical trial is necessary for certain medical devices. “Applicants are encouraged to use the most effective way to demonstrate safety, efficacy and performance of medical device, and eliminate or reduce unnecessary clinical burdens”, the document says. The necessity of clinical trials should five aspects into consideration. Please click HERE for full article
All Class III Devices & IVDs Subject to UDI Starting June 1, 2022
Unique Device Identification (UDI) will be implemented with all Class III devices, announced by NMPA at the “Notice on Applying Unique Device Identification System for the Second Group of Devices” on September 17, 2021, with the effective date of June 1, 2022. Starting from that time, for initial registrations, renewal and modification registrations, the applicants shall submit the identifiers of the smallest sales unit to the registration management system.
The document also gives instructions for recall, traceability, data uploading and public tendering and reimbursement. Click HERE for more information
Three Medical Devices Receive Innovation Approval
NMPA granted Innovation Approvals to three medical devices in September 2021. As of September 2021, NMPA issued 121 innovation approvals since the pathway established in 2014. Click HERE for the complete list and the qualifications
About China Med Device, LLC
China Med Device, LLC (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.