The NMPA Medical Device Standardization Administration released the second batch of results for medical device classification, excluding 86 products as medical devices. It also identifies 60 Class III, 94 Class II and 49 Class I medical devices, and 23 devices parts and 4 as combination devices.
In the first batch results of device classification released in March 2020, 139 products are managed as non-medical devices. Therefore, in 2020, a total of 225 products are no longer classified as medical devices. Those classified as Non-Medical Devices includes:
- Delivery Tub
- Disposable Baby Bottle (including pacifier)
- Antifogging Fluid for Medical Isolation Eye Mask
- Electric toothbrush
- Zeolite antidote
- Tweezers for dental ampoules
- Dental Denture Molding Fluid
- Vaginal douche
- Negative pressure pipeline on-off controller
- PLGA cell culture beads
- Pen-type syringe assembly in pre-filled medicinal liquid pen-type syringe
- Plantar wart, tinea pedis and onychomycosis treatment spray
- Nasal spray
- Medical ray protection spray
- Sleep monitor
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About China Med Device
China Med Device, LLC, provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA (CFDA) 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 (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.