News
Guidelines covering technical review / clinical trials / clinical evaluation for the registration of medical devices in China
2 medical devices were passed for the fast-track approval, whilst the NMPA accepted the applications for the fast track approval of 8 medical devices.
NMPA Issues 2019 Annual Report, Strengthening Scheme and Updates on Medical Device Mandatory Standards in China
In July 2020, the SAMR announced two drafts concerning health food products and launched the public consultation to solicit comments
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.
On July 31, 2020, the Beijing MPA (Medical Products Administration) made an announcement to implement stricter supervision on medical cosmetology products.
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 June 29, 2020, China’s State Council announced the implementation of the new regulation for CSAR (Cosmetics Supervision and Administration), which will become effective on January 1, 2021.
Major changes
Background
The definition of cosmetics
Classification of Cosmetics
Note: Registered products with functions for hair growing, depilatories, breast enhancement, body slimming, and deodorants will no longer be classified as special cosmetics after a 5-year transition period.
Classification of Cosmetic Ingredients
Note: After the registration / filing of new ingredients, the registrant / filer should report the current status of consumer use and safety to the NMPA annually for 3 consecutive years. If any safety issues should occur during these three years, the registration / filing will be cancelled, otherwise, the new ingredient will be included in the list of used ingredients (IECIC, also known as Inventory of Existing Cosmetic Ingredients in China).
Toothpaste management
Note: According to the China Oral Care Industry Association’s announcement on July 2, 2020, toothpaste products are not considered as cosmetics. Further information will be disclosed by the NMPA.
Soap management
Requirements for registrants and filers
Penalties for violations
By Jacky Li. Contact Cisema if you would like to learn more.
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.
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.
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