Medical Devices
On July 7, the CMDE (Center of Medical Device Evaluation) of NMPA (National Medical Products Administration) announced the initiative to draft the technical review guidelines for the registration of personalized implants using additive manufacturing.
Manufacturers were invited to sign up before July 20 to provide any assistance needed by the CMDE.
By Jacky Li. Contact Cisema if you would like to learn more.
On June 24, the CMDE (Centre for Medical Device Evaluation) of NMPA (National Medical Products Administration) released the technical review guidelines (draft) addressing the evaluation and characterization methods for unknown leachables studies during the medical device registration process.
According to the draft guidance document, leachables are defined as the chemical substances released from the medical device and/or its materials of construction during the conditions of clinical use.
In many cases, the leachables studies are necessary to determine the safety use of medical devices in the market and avoid patients from being exposed to toxic substances.
Requirements for the evaluation report
- Device information in terms of structure and materials used for the future reference of compatibility studies
- Extraction profile including the choice of solvent, as well as the time, ratio and method of extraction used
- Qualitative analysis and results
- Quantitative analysis and results
- Conversion of the measured level of chemical substance to the level of clinical exposure
The public consultation ends on July 30, 2020.
Contact Cisema if you would like to learn more about the above news.
By Jacky Li.
In this exclusive webinar, we will analyse and describe the market opportunities and regulatory hurdles for MedTech in China.
The Hainan MPA announced an increase of 292% overseas applications received for medical devices to enter the Hainan Pilot Zone.
NMPA and Allergan co-hosted the webinar to share the transformation of real-world data in China and how to use real-world data in registration applications.
NMPA legal agents shall formulate risk control measures due to raw material changes during the manufacturing process of passive medical devices.
NMPA granted fast-track approval to Novocure's Optune, the first overseas innovative medical device to treat glioblastoma in China.
NMPA published a notice addressing the work items for medical device sampling inspection, reinspection, objections and appeals, etc.
The NMPA drafted a guidance document to include human factors/usability engineering (HFE) for the registration of medical devices.
The Standardization Administration of China released the GB 9706.1-2020 addressing new safety and performance requirements for medical electrical equipment.
Once a medical device is approved for use within the Pilot Zone, hospitals can use a special pathway to apply for NMPA registration in China.
NMPA solicites public opinions on the draft proposal to reclassify IVD reagents in the 6840 Classified Subdirectory (2013 Version).
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