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
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. For the list of devices please click HERE
Within 22 Working Days, Licensing will be Granted for Urgent Needed Devices in Hainan
Hainan government issued the “Regulations on the Administration of Urgently Needed Imported Drugs and Medical Devices in the Boao Lecheng International Medical Tourism Pilot Zone of Hainan Free Trade Port” on March 28, which will come into force on May 1, 2023.
The document speculates that the r designated medical institutions is responsible for the safety risks of the usage, and the risks of drugs and devices shall be controllable, the source shall be legal, the storage shall be standardized, and the supply pathway shall be clear. It also regulates the circumstances of damage compensation and suspended usage. Click HERE for the timeline and the review focuses
New IVDs Classification Catalog Proposed
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.
Click HERE for 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; Click HERE for the complete list
Guidelines & Standards
China Medical Electrical Standards Effective May 1, 2023; Grace Period Granted
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.
For our comprehensive review please click HERE
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”.
Click HERE for more information
- SEO Powered Content & PR Distribution. Get Amplified Today.
- Platoblockchain. Web3 Metaverse Intelligence. Knowledge Amplified. Access Here.
- Source: https://chinameddevice.com/china-medical-device-march-2023/
- :is
- $UP
- 1
- 2023
- 28
- access
- According
- administration
- and
- announced
- applicable
- April
- ARE
- attention
- based
- BE
- Beijing
- brought
- by
- catalog
- Centers
- centralized
- certain
- certificates
- Changes
- China
- chinese
- Chinese market
- circumstances
- classification
- clear
- click
- Clinical
- come
- commission
- compared
- Compensation
- complete
- comprehensive
- conditions
- Conduct
- covers
- Date
- Days
- December
- Demand
- departments
- designated
- Determine
- Development
- device
- Devices
- document
- Drugs
- each
- Effective
- Equivalent
- Ether (ETH)
- example
- existing
- expected
- feedback
- For
- Force
- Free
- from
- further
- GBA
- gives
- Government
- granted
- Group’s
- Health
- health insurance
- historical
- hospitals
- HTTPS
- implementation
- improve
- in
- industry
- innovative
- institutions
- insurance
- International
- Issued
- IT
- items
- latest
- Legal
- Licensing
- List
- Lists
- LLC
- local
- mandatory
- Manufacturers
- March
- Market
- medical
- medical device
- medical devices
- Meet
- methods
- more
- National
- needed
- needs
- New
- New technologies
- news
- News Roundup
- of
- offices
- on
- outside
- partner
- Pay
- payment
- payment system
- people’s
- period
- pilot
- plan
- plato
- Plato Data Intelligence
- PlatoData
- please
- policy
- presented
- previous
- process
- Product
- Products
- Progress
- propelling
- PROS
- Provincial
- quality
- Recommendation
- regulatory
- related
- reply
- Requirements
- responsible
- review
- risks
- roundup
- Safety
- Second
- Source
- Space
- standards
- storage
- submitted
- supply
- support
- Supporting
- suspended
- system
- Technical
- Technologies
- Technology
- Testing
- that
- The
- The Source
- These
- timeline
- to
- Tourism
- trade
- Updates
- urgent
- Usage
- use
- which
- will
- with
- working
- Your
- zephyrnet