Here’s the latest China regulatory and clinical affairs China NMPA News March 2022 for medical device and IVDs pros. These updates are presented by China Med Device, LLC, your partner in Chinese market access.
China GCP Introduced, with Renewed Requirements on Multi-Regional Trials and Safety Reporting
NMPA and China Health Commission released the “Quality Management Practice Specification for Clinical Trials of Medical Devices”, implemented from May 1, 2022.
The “China GCP” covers the whole process of medical device clinical trials, including the design, implementation, supervision, inspection, inspection, data collection, recording, preservation, analysis, summary, and reporting. View our comprehensive review.
NMPA Down-Classified Certain Neuro, Cardiac Surgery Devices
The NMPA reclassified certain neurosurgical, cardiac surgery, orthopedic, and aesthetic devices and modified intended use for some with an announcement on March 24, 2022.
Six neurosurgical and cardiac surgery devices are down classified from Class III to Class II. Check out the full list.
Implantable Cardioverter Defibrillator, Intracranial Embolization Device Allowed for Contract Manufacturing
The NMPA published the “Catalog of Medical Devices Prohibited from Contract Manufacturing” on March 24, 2022. Compared with the draft version, issued in November 2021, with 22 devices on the list, the final document permits nine devices for contract manufacturing. See the full list.
Hainan Asks Pilot Trial of Imported Neurological Products
Hainan Lecheng Boao International Medical Pilot District released “Pilot Trials of International Innovative Neurological Products” on March 29, 2022, to solicit imported products from neurological device manufacturers, research institutions and hospitals. The deadline is April 24, 2022.
Guidelines & Standards
Three Guidelines Propel China to be World Leader in Digital Health
The NMPA released three guidelines in a single day, March 9, 2022, to regulate and support the rapid development in digital health:
Boston Scientific Obtained Two NMPA Approvals through Hainan RWD
The NMPA granted approvals to two devices, Boston Scientific’s Rezūm Water Vapor Therapy equipment, and its disposable prostate treatment accessory on March 3, 2022. It only took four months for the two devices from submitting the registration application to guaranteeing approval.
The two devices utilized the same pathway, Hainan Real-World Data program, as Allergan’s glaucoma drainage system, and J&J’s femtosecond laser eye treatment system. Read the overview of the two devices and Hainan RWD program.
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.