Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in March 2023. These updates are presented by China Med Device, LLC, your partner in Chinese market access.
Policies
2023 National Inspection Plan: Pay Attention to Your Device Standards
The NMPA announced the “2023 National Inspection Plan for Medical Devices” on March 31, 2023. The Plan asks provincial NMPA offices and testing centers to conduct quality inspections based on Mandatory Standards and Product Technical Requirements (PTRs).
The plan covers 68 medical devices and IVDs, and NMPA lists the inspection items for each product. View the list of devices.
Early Market Access Approval for NMPA Unapproved Devices and Drugs in Boao, Hainan, China, will Take 22 Official Review Days
Hainan government released the “Regulations on the Administration of Urgent Use Imported Drugs and Medical Devices in the Boao Lecheng International Medical Tourism Pilot Zone of Hainan Free Trade Port” on March 28, which will be effective on May 1, 2023. This special policy allows early commercial access to China Boao a lot faster than the national approval. It does NOT require local type testing or significant burden of proof as the national approval. Not all products fit in this special zone.
Imported Medical Devices for clinically urgent use refer to devices that are urgently used in medical institutions in the Pilot Zone. The devices have been approved for sale overseas, and have no same products approved by China NMPA. Read the timeline and the review focus.
New IVDs Classification Catalog Proposed
The CMDE issued the “Draft Classification Catalog for IVD Reagents” on March 14, 2023, to “keep up with the regulatory and industry development needs brought by new technologies, methods and biomarkers.” Feedback needs to be submitted by April 20, 2023.
Check the expected changes compared with the previous catalog.
Additional Fourteen Hospitals Designated in GBA Propelling Urgent Use Policy
Guangdong Health Commission issued the second batch of 14 applicable institutions to pilot urgent use policy. View the complete list.
Guidelines & Standards
China Medical Electrical Standards Effective May 1, 2023; Grace Period Granted
The NMPA issued the “Notice on Implementation of GB 9706.1-2020 and Supporting Standards”, equivalent to IEC60601, on March 16, 2023, with effective date of May 1, 2023. For manufacturers with existing NMPA certificates, grace period has been granted to comply by December 31, 2025.
Read our comprehensive review.
Priority Approvals
Innovation Devices Exempted from DRG in China
The National Health Insurance Administration issued the “Reply to Recommendation No. 3298 of National People’s Congress” on March 4, in which the Administration agrees to further improve the payment system of Diagnosis Related Groups (DRGs) which exclude the innovative products.
In the Reply, the Administration gives support to local medical insurance departments to pilot the CHS-DRG exclusion payment. For example, Beijing will exclude drugs, medical devices and diagnostics that meet certain conditions in the payment of CHS-DRG system.
The Administration also pointed out that in the process of centralized procurement, medical institutions determine the demand according to historical usage, clinical use and medical technology progress, and “set aside market space, outside of centralized procurement, for innovative products”.