Medical Devices
On June 9, 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:
- Reagents for rotavirus antigen tests
- Real-time qPCR instruments
- Reagents for testing IgM and IgG antibodies against HPV B19
- Reagents for GBS nucleic acid tests
Manufacturers of the above products were invited to sign up and cooperate with the CMDE to provide any needed assistance.
On July 1, the CMDE released the technical review guidelines (2nd draft) for the change of licensing items for IVD Reagents. The CMDE is currently soliciting public comments until July 25, 2020.
On July 3, the CMDE of NMPA announced the initiative to draft the technical review guidelines for the registration of IVD reagents utilizing overseas clinical data.
By Jacky Li. Contact Cisema if you would like to learn more about the above news.
On June 5, the NMPA issued the technical review guidelines (No. 36 – 2020) for the registration of the following medical devices:
- Tendons and Ligament Fixation Device
- 3D Printed Acetabular Cup
- 3D Printed Artificial Vertebral Body
- Facial Implants for Plastic Surgery
- Total Knee Prosthesis System
On June 17, the NMPA issued the technical review guidelines (No. 39 – 2020) for the registration of the following medical devices:
- Heat and Moisture Exchanger
- Low Frequency Electrotherapy Instrument
- Electrical Pneumatic Tourniquet Device
- Spirometry Device
- Medical CO2 Incubator
- Shockwave Therapy Device
- Hot Therapy Pack
- Audiometer
On June 17, the NMPA issued the technical review guidelines (No. 42 – 2020) for the registration of the following medical devices:
- Synchronized Cardioversion Device
- Transcutaneous Pacemaker
By Jacky Li. Contact Cisema if you would like to learn more.
On July 1, the CMDE (Centre for Medical Device Evaluation) of NMPA (National Medical Products Administration) released the draft guidance document for the registration of citric acid disinfectant products.
Disinfectant products are Class III medical devices and are exempted from clinical trials. The draft guidance document addresses the following basic dossiers required during the NMPA registration process:
Product Descriptions
- All of the ingredients, formula, content, pH value, temperature for use, expiry date etc.
- Comparison table will be required to fill in when necessary
- Material used for initial packaging
Product History
- Sales performance
- Status of research and development
- Occurrence of any adverse events
- Same type of disinfectant products or predecessor products for comparison
Product Scope
- Environment intended for use
- Conditions for use
- Precautionary statement
Market surveillance of raw materials
- Submit the names, codes and formula of the all the chemical entities used
- Name of supplier
- Conformity standards
The public consultation ends on August 3. Read our recent article about the approval process and revised standards for disinfectants in China.
By Jacky Li. Contact Cisema if you would like to learn more.
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.
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