Here’s the latest China NMPA regulatory and clinical affairs news in September 2020 for medical device and IVDs pros. These updates are presented by China Med Device, LLC, your partner in Chinese market access.
Hainan: Device Importation Processing Time Shortened to Three Days
Hainan government published “The System Integration Innovation Reform Plan of Boao Lecheng International Medical Tourism Pilot Zone of Hainan Free Trade Port”, unveiling a range of first-of-its-kind policies. Importation Processing time of foreign registered drugs and devices, indicated for clinical urgent needs, are shortened to three working days.
The plan also proposes the creation of China’s only “global licensed drug insurance”, the construction of China’s only centralized storage bonded warehouse for overseas innovative pharmaceuticals and equipment that are not yet marketed in China, and the establishment of China’s only whole-process traceability platform for unlisted licensed drugs and medical devices, etc. Click HERE for full article
Encourage Imported Devices to Localize in China with a Simplified Registration Process
NMPA issued the final notice “Issues regarding Approved Imported Medical Devices Manufactured by Chinese Domestic Enterprises”. The announcement encourages foreign manufacturers to localize their approved devices’ production in China with providing an expedited approval pathway for their devices made in China. The pathway becomes available on the premise that the main raw materials and production processes do not change, and the quality management system is consistent with previous one.
Many deliverables such as the research summary or clinical evaluation report will be allowed to be reused; new Product Technical Requirement and new Product Registration Testing Report are required. Click HERE for full article
Cybersecurity Guideline Asks for Feedback
NMPA published “Draft Technical Guideline on Medical Device Cybersecurity”. The guideline is to direct the registration of Class II&III medical devices (including domestic and imported) that have functions like electronic data exchange, remote control or data storage. It is applicable to initial products registrations, modifications, and renewals. For instructions for registration and takeaways for manufacturers please click HERE.
UDI Implementation Date Delayed to Jan 1, 2021
NMPA delayed the UDI implementation date for the first batch of medical devices from October 1, 2020 to January 1, 2021. It also adjusted the UDI application scope and the timeline. Click HERE For detailed information
NMPA issued nine guidelines in September to direct manufacturers for local testing and registration. The guidelines cover indications of orthopedic, cardiovascular, hematology, general hospital, etc. Click HERE for the list of the guidelines
In the third quarter of 2020, NMPA posted recall notices regarding 26 medical devices and IVDs. Please click HERE for the analysis of the recalls, with the complete recall list, indication and major causes.
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 and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA regulatory services include strategy, registration, local 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.