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NMPA Roundup February 2023

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Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in February 2023. These updates are presented by China Med Device, LLC, your partner in Chinese market access.

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.

View the full hospitals list.

UDI for Class II Devices Starting June 1, 2024

The 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

Read 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:

  1. 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).
  2. 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.

See more information.

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.

View the full Class II and III approvals list.

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%.

Read 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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