Policies
Additional Fourteen Hospitals Designated in GBA Propelling Urgent Use Policy
On February 22, 2023, Guangdong Health Commission issued the second batch of applicable institutions to pilot urgent use policy, in which 14 hospitals are included; among them, five are public tier 3 hospitals.
While not-yet-approved in the mainland, Hong Kong or Macao approved drugs and medical devices can be utilized in GBA. They can be used only if the significant clinical benefits with urgent needs can be demonstrated. Guangdong provincial NMPA will decide on import approval within 20 working days.
For the full hospitals list, please click HERE
UDI for Class II Devices Starting June 1, 2024
NMPA announced many Class II devices to subject to UDI on February 10, 2023. The document “Implementation of the Third Batch of Medical Devices UDI”, asks manufacturers to prepare for UDI inclusion for the following Class II devices:
- disposable products with large clinical demand
- varieties included in the scope of medical insurance
- medical cosmetic products
Click HERE for our comprehensive review with the devices list
NMPA Supplement Phase Changes as Covid Ending
The CMDE published a revision of the supplement phase on February 20, 2023, suggesting that it is ending Covid measures on medical device registration. The notice says that:
- For “medical device supplementary information notice” issued before February 20, 2023, the period for supplementing the information will be extended by one year (two years in total).
- For “medical device supplementary information notice” issued on and after February 20, 2023, the time limit for submitting supplementary materials will be restored to one year.
For more information click HERE
Device Approvals
Two Implantable Resynchronization Cardioverter Defibrillators Got NMPA Nod
The NMPA issued a notice summarizing device approvals this month. In total of 23 imported Class II and III were approved, among them are two implantable cardiac resynchronization cardioverter defibrillators from Abbott and St. Jude Medical.
For the full Class II and III approvals list click HERE
Sixty-Nine Imported Ventilators Got NMPA Nod to Combat Covid, Standing for 40% of Total Approvals
The NMPA issued the “List of Ventilator Products Approved by Drug Administration”, in which 176 ventilator approvals are listed. 69 overseas products are included, accounting for about 40%.
Click HERE for 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.
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- Source: https://chinameddevice.com/medical-device-february-2023/
