Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in June 2022. These updates are presented by China Med Device, LLC, your partner in Chinese market access.
Policies for NMPA June 2022
Certain Class III Devices Exempted for Clinical Trial: Cardio/Neurosurgery, Radiation, Imaging, Ophthalmology and More
NMPA issued the “Clinical Pathway Recommendations for Certain Categories of Medical Devices” on June 16, 2022. The document suggests manufacturers how to choose clinical evaluation exemption, predicate device comparison or clinical trial.
Wide range of Class III devices, with indications of neurosurgery and cardio surgery, radiation therapy, medical imaging, ophthalmology, obstetrics, and assisted reproduction, are affected. Check out the complete list.
MAH Available in GBA, Allowing Contract Manufacturing
The NMPA published “Implementation Plan for Supporting Hong Kong and Macao Drug Market Authorization Holders to Produce Drugs and Medical Devices in 9 Mainland Cities in the Greater Bay Area (GBA)” on June 29, 2022. To facilitate the urgent use policy in GBA in the manufacturing phase, the document clarified responsibilities for foreign MAH and its designated contract manufacturers. Read our comprehensive review.
Guidelines & Standards NMPA June 2022
NMPA Issued 2022 Guidelines Revisions Plan
The NMPA published the “2021 Medical Device Guidelines Revisions Plan” on June 23, 2022, in which 75 guidelines are affected. The revisions are aimed to facilitate manufacturers with local type testing and make guidelines more consistent with the international counterparts.
The plan involves the guidelines for technical review for type testing, clinical trial and registration, and Indication for Use (IFU) writing. View the list of guidelines impacted.
Guideline of Drug-Coated Balloon Dilatation Catheter Asks Feedback
CMDE issued the “Guideline of Drug-coated Balloon Dilatation Catheter (draft)” today on June 22, 2022, collecting public opinions. Feedbacks need to be submitted by July 22, 2022.
Referring to “ASTM F3320-18 Standard Guide for Coating Characterization of Drug Coated Balloons”, the proposed guideline is trying to keep up with international standards. It offers recommendation on composition materials, research materials and clinical evaluation, etc. Read more detailed information.
Fast-Track Approvals
Three Gastroenterology & Urology Devices Obtain NMPA Innovation Approval in June
The NMPA granted Innovation Approvals to three gastroenterology and urology devices in June 2022:
NMPA also issued the list of 163 innovation approvals since the pathway established in 2014. See more information.
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.