News
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July 1, the CMDE (Centre for Medical Device Evaluation) of NMPA (National Medical Products Administration) released the draft guidance document for the registration of citric acid disinfectant products.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 The draft guidance document addresses the following basic dossiers required during the NMPA registration process: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.
Cisema will jointly present a webinar session with the Chamber of Commerce (IHK) Lübeck on August 29 to provide an overview of the market potential and registration of medical devices and IVDs in China.
The session will be interactive, and will go through many interesting topics:
- The Chinese market
- The authorities and other players in China
- The admission requirements and responsibilities
- Legal representation of the manufacturer - Legal Agent
- Post Market Surveillance
- Recent changes in the registration process
- New approaches to simplified market access in certain regions
Date: August 26
Time: 9:00 am – 11:00 am
Price: Free of charge
Open for public
Our speaker: Markus Roepke
Language: German
Cisema will jointly present a webinar session with the China-Britain Business Council on July 30 to provide an overview of the latest policies and market opportunities for digital healthcare in China.
The session will be interactive, and will go through many interesting topics:
- What are the key digital health trends in China?
- How does risk class classification for the NMPA (former CFDA) work?
- Are there any fast-track regulatory pathways?
- What are the latest updates regarding digital health regulations?
Date: July 30
Time: 09:30AM – 10:30AM
Price: Free of charge
Open for: CBBC members only
Our speakers:
Anna King
Business Consultant, Cisema
Hamish King
Director of Business Development, Cisema
Due to the increased demand, overseas disinfectant manufacturers are looking for ways to comply with the regulatory framework for China market entry.
Beijing, July 3, 2020:
The certification organization CCAP (China Certification Centre for Automotive Products) has published the 2020 revision of its implementing regulation CCAP-GZ-5101 for product certification of automotive interior materials. It replaces the 2019 revision immediately.
The new revision CCAP-GZ-5101:2020 contains additions and amendments for buses.
In particular, the additions include:
- GB 38262:2019 Flammability of interior materials for buses
- GB 24407:2012 Technical Safety Specifications for Dedicated School Buses
Manufacturers of components affected by the added standards are requested to submit applications to update their existing certificates. This will require tests according to the standards mentioned above. For non-affected manufacturers, existing certificates will be automatically updated to CCAP-GZ-5101:2020 at no additional cost the next time an application is submitted, for which the certificate must be changed.
By Florian Waegele. Contact Cisema to learn more.
Beijing, June 12, 2020:
The certification authority CNCA (Certification and Accreditation Administration of the People's Republic of China) gave three definitions, which so far have led to confusion:
- Further definitions of the mandatory 17 CCC product groups which are intended to make the identification clearer.
- Should a product have characteristics which would make it mandatory to be certified according to CCC and other Chinese product certifications, it should only be certified according to CCC.
- In case CCC certificates have already been issued which violate the above two points, they shall be cancelled by the certification organization as soon as possible.
Related News: Extensive additions for CCC and EX in China as of October 1st, 2019
By Florian Waegele. Contact Cisema to learn more.
Beijing, June 11, 2020:
The certification organisation CCAP (China Certification Centre of Automotive Products) started to issue its certificates for CCC (China Compulsory Certification) and voluntary product certifications in electronic form on June 5, 2020. They will be provided together with the conventional printed form.
For certificates issued before June 5, 2020, the organisation will provide an electronic version when the next change is made.
Read our related news: CQC implements e-certificates for CCC and other certifications
By Florian Waegele. Contact Cisema to learn more.
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.
CCC implementation rules CNCA-C22-01:2020 for children's vehicle and CNCA-C22-02:2020 for toys come into force on 1.July.2020.
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.
Get in Touch with Our Consultants
And discover how we can support you.