Medical Devices
In July 2020, the NMPA (National Medical Products Administration) announced three drafts and launched a public consultation to solicit comments
In July 2020, the CMDE issued a notice requesting domestic and overseas manufacturers‘ assistance to draft the technical review guidelines for 15 medical...
The CMDE asks for the input from medical device manufacturers in the field of tissue regeneration for support in their research and technology development.
The Beijing MPA has announced the implementation of a grading system for medical device violations in Beijing.
The “Artificial Intelligent Medical Device Innovation and Cooperation Platform” announced their recent developments concerning AI medical devices
From October 1, 2020 onwards, the registered applicant/registrant of medical devices listed in the first batch must submit the product identification (DI)
On July 29, 2020 the CMDE (Center for Medical Device Evaluation) of NMPA (National Medical Products Administration) released a draft of the proposed amendment to the list of medical devices and IVDs to be exempted from clinical trials:
The draft proposes to add 53 medical devices (Class II: 34; Class III: 19) and 15 IVDs (Class II: 13; Class III: 2) to the clinical trial exemption list. Also, the names and descriptions of 11 medical devices (Class II: 9; Class III: 2) are proposed for revision, while there are 2 medical devices being combined with other products.
Here are the links to:
Proposed amendment for the list of medical devices to be exempted from clinical trials
Proposed amendment for the list of IVDs to be exempted from clinical trials
The CMDE is currently soliciting for public comments, and the public consultation ends on August 31, 2020.
By Jacky Li. Contact Cisema if you would like to learn more.
Organizer: BioM Biotech Cluster Development GmbH
Date: July 30, 2020
Time: 10:00 - 12:00 pm (CET)
Venue: Online
Register here on organizer's website
Contact: Dr. Andreas Berghammer , Tel.: +49 (0) 89-899679-17
Anja Weber, Tel.: +49 (0) 89-899679-35
Organizer: SPECTARIS GmbH
Date: October 14, 2020
Time: 10:00 am - 11:30 am (CET)
Venue: Online
Register here on organizer's website
Contact: Ms. Peggy Zimmermann, Tel.: 030 414021-15
Organizer: FORUM • Institut für Management GmbH
Date: Part I + II on August 25 - 26, 2020 | Part III on September 1, 2020
Time: 9:00 - 11:00 am (CET)
Venue: Online
Language: English
Register here on organizer's website
Contact: Ms. Ute Akunzius-Jehn, Tel.: +49 6221 500-685
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.
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.
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