Policies
Hundreds of Standards to be Obsoleted or Declassified: Faster Market Access for Ophthalmic and Orthopedic Devices
The NMPA issued the “Optimizing Mandatory Standards for Medical Devices (Draft)” on January 5, 2022 for feedback. Feedbacks need to be submitted by February 10. The document lists 458 standards, many of which are for ophthalmic and orthopedic indications, proposing to make changes by obsoleting, keeping in effect or declassifying from “mandatory” to “recommended”. Please click HERE for the list
Guidelines & Standards
Use the Clinical Evidence of Predicate Device for Product Registration
If devices are not on the clinical evaluation exempt catalog but have an NMPA-approved predicate device to show substantial equivalence, per the “Guidance for Clinical Evaluation of Medical Devices” published on Sep 28, 2021, the applicant can use the clinical data of the predicate device as a part or the total clinical evidence of the product to be registered for NMPA registration. The clinical data of predicate can be used as an alternative to local clinical trial to meet NMPA clinical requirements. For takeaways for manufacturers please click HERE
Guideline Published for Combination Products
NMPA released the “Registration Guideline on Combination Products with Device as Primary Mode of Action” on January 11, 2022, directing manufacturers for safety and efficacy evaluation of combination products.
The applicant should evaluate the safety and efficacy of the product using the combination medical device as a single entity, paying special attention to the potential risks introduced by the drug or the interaction between the device and the drug. The applicant can make an assessment on the drug information, but the safety and efficacy of the drug in the combination product may be different from that of the drug used alone. For the requirements on the clinical evaluation and registration application, please click HERE
Fast-track Channels
Four Neurological Devices Receive NMPA Innovation Approvals in January 2022
The NMPA granted Innovation Approvals to four neurological devices in January 2022:
Since the pathway established in 2014, 142 innovative devices have been approved. For the explanation NMPA gives for each approval, please click HERE
Fast-track Channel in 2021: Roche, CooperVision Got Priority Approvals
In 2021, six priority review devices and 15 innovation devices received approvals, while 50 devices were granted fast-track channels. Roche and CooperVision are on the approval list as imported devices. For our comprehensive review with the complete approval list please click HERE
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.
