Medical Devices

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.