Medical Devices

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According to the draft guidance document, leachables are defined as the chemical substances released from the medical device and/or its materials of construction during the conditions of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.

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 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 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 24, the NMPA released the draft catalog of class III medical devices requiring clinical trial approval. In the draft catalog, the following device categories were proposed:

• Implantable cardiac rhythm management device
• Implantable ventricular assist system
• Implantable drug infusion device
• Artificial heart valve and intravascular stent
• Tissue engineering medical products containing living cells
• Absorbable implants for the fixation of long bone

The public consultation is currently running until July 31, 2020.

By Jacky Li. Contact Cisema if you would like to learn more about the above news.

On July 2, the NMPA (National Medical Products Administration) released the updated guidance document for preparing the periodic risk evaluation report for medical devices addressing the timescale and data collection scope for preparing and submitting the initial report:

• For medical devices in their first registration / filing cycle, the registrant should complete and submit the periodic risk evaluation report within 60 days after each full year.

• The periodic risk evaluation report of Class II and Class III medical devices should be submitted online via the NMPA adverse event reporting system

• The period risk evaluation report of Class I medical devices should be prepared annually for the first five years, and should only be submitted when required. The preparation of annual reports can be omitted after 5 years.

• For medical devices whose specifications were registered in different certificates (e.g. different specifications of disposable sterile syringes) or medical devices that must be used together with other devices under a different registration certificate (e.g. hip systems which include acetabular cups, femoral stems, etc.), the risk assessments can be incorporated into one report, but should be submitted before the earliest deadline. The registrant should include any related information of the medical devices upon the submission or archiving of the report. If the registrants intend to incorporate the risk assessments into one report for medical devices of the same kind, they should conduct a subgroup analysis based on the registration certificate number.

By Jacky Li. Contact Cisema to learn more.