News

On June 4, the NMPA (National Medical Products Administration) published (No.57 – 2020) the guidelines for on-site inspections on standalone SaMD (Software as Medical Devices) in China. This guidance document was written in line with the NMPA‘s Medical Device GMP Appendix: Independent Software and addressed the obligations of the inspector which include, but are not limited to the following:

• Check if the GMP handbook illustrates the corporate’s structure, mission, policy and decision-making process in relation to the quality assurance projects as required
• Check if the manufacturing sites and facilities meet the standard requirements of a manufacturing environment (e.g., water-proof or anti-static) and the code of practice on the packaging, labelling and storage of SaMD
• Check and randomly inspect the filing records of the software and hardware resources (e.g., anti-virus protection, data backup and data recovery)
• Check if the research and development projects are under the surveillance of safety protocols and risk management measures
• Check if the policies have been implemented to monitor and control the quality of production, sales and after sales services, nonconforming outputs, and adverse events

On June 5, the CMDE (Center for Medical Device Evaluation) of NMPA (National Medical Products Administration) released the draft amendment of the technical review guidelines for SaMDs (Software as Medical Devices) with the dossier submission requirements for registrations, registration renewals and change of licensing items.

By Jacky Li. Contact Cisema if you would like to learn more.

On June 2, the Hainan MPA announced (No.28 – 2020) the implementation of the new regulation to support the urgent clinical needs of medical device imports in Hainan’s Boao Lecheng International Medical Tourism Pilot Zone, also known as the Boao Hope City, replacing the temporary regulation (No.30 – 2019) announced in April 4, 2018.

What’s New?

• Medical institutions, importers and warehouses must keep a record of incoming and outgoing goods (with receipts as proof):
  • The records must be kept as long as 3 years (after expired) for medical device products with an expiry date
  • The records must be kept as long as 5 years for medical device products without an expiry date
  • The records must be kept forever for implantable medical device products
• Medical institutions are required to monitor the status of imported medical devices with clinical needs, establish a management system for adverse events reporting and address the responsible person to follow up

Prerequisites for importing medical devices urgently needed for clinical treatment

• There are no medical devices of the same type existing in the market yet
• The medical device can effectively provide clinical treatment or prevention to the subject (patient) with a life-threatening disease
• The medical device demonstrates significant clinical advantages

By Jacky Li. Contact Cisema if you would like to learn more.

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 (2^nd 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

Online Registration Link

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

Online Registration Link

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:

1. Further definitions of the mandatory 17 CCC product groups which are intended to make the identification clearer.
2. 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.
3. 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.