Medical Devices
On 05.11.2018, the NMPA (former NMPA) published the “Special Approval Procedures for Innovative Medical Devices” (NMPA No. 83-2018), which will take effect on December 1, 2018. The draft version (NMPA No 13-2014) was abolished. The document clarifies the review procedure and requirements for innovative medical devices.
On 07.09.2018, the CDME added two new functions based on the original online reservation consultation platform for medical devices in review, one is for innovation/priority approval medical device, and the other for clinical trial approval.
On 08.10.2018, the CMDE released new guidelines for the technical review of the sterilization processes of sterile medical devices for public comments. It includes requirements for the preparation of relevant documents as part of the registration of sterile medical devices.
Customized medical devices are expected to improve the effect of diagnosis and treatment for designated patients as personalized products.
As mentioned in our March/April news: On 13.03.2018, during the 13th National People's Congress, China’s cabinet decided for the SAMR (State Administration for Market Regulation) to supervise the - NMPA (China Food and Drug Administration), - AQSIQ (General Administration of Quality Supervision, Inspection and Quarantine), and- SAIC (State Administration for Industry and Commerce).The “3 stipulation scheme” published in August by the State Council details the staffing, administrative structure and functions of the SAMR.
On 14.08.2018, the SAMR defined the 8th batch of Drug - Medical Device Combination Products in their announcement No. 218-2018. When applicants are unsure, whether a product is categorized as a medical device or drug, a classification application can be submitted to the SAMR for verification.
On 07.05.2019, the CMDE (Center for Medical Devic Evaluation), announced the introduction of NMPA’s new eRPS System (Electronic Regulated Product Submission System - https://erps.cmde.org.cn). The system is used for the electronic management of medical device registrations. In future, all documents for NMPA registrations shall be submitted to through this eRPS System. No hard copy documents will be necessary.Since 10.05.2019, it is possible to apply for a CA (Certificate Authority) certificate via the eRPS System. The CA certificate is necessary to be able to log into the electronic submission system. Every registration applicant of domestic medical devices class III has to apply for a CA certificate. Equally, every NMPA Legal Agent of an imported medical device has to apply for a CA certificate on behalf of the NMPA registration applicant, the foreign manufacturer.
On 03.07.2019, the NMPA initiated the Pilot Work Plan for the “Unique Device Identification” (UDI) (No.56-2019), as announced in February 2018. The UDI mark, is made up of a combination of numbers and barcodes. It carries information about the product (i.e. identifying the license holder, the model specification and packaging) and its production (i.e. production batch number, production date, expiration date). The NMPA will approach applicants, which have to provide UDI applying for approval. During the pilot phase, it will be for high-risk medical devices only (such as heart, craniocerebral implants and prostheses).
On 01.08.2019, the CMDE (Center for Medical Device Evaluation), published a revised “Clinical Trial Exemption List for Medical Devices”. 101 Class II and 41 Class III medical devices were added. The new clinical trial exemption list contains a total of 996 medical devices now. With regards to IVDs, 420 of class II and III IVDs are exempted.
The principles describe the manufacturing requirements to ensure the medical device operates safely and performs as intended。
According to the Guide, the registrant of the medical device is responsible for implementing a suitable QMS for the product realization process.
On 10.04.2020, the NMPA (National Medical Products Administration) made the announcement No.25-2020 to provide guidance to NMPA Legal Agents on the timescales for monitoring and reporting medical device adverse events.
A summary of the NMPA Legal Agent responsibilities for monitoring medical device adverse events:
- A well-established monitoring system for medical device adverse events
- Based on the business structure, an appropriate percentage of staffs should be assigned to monitor medical device adverse events
- Collect, report, investigate, analyse and evaluate medical device adverse events in a proactive manner
- Take effective measures for risk control and inform the public in a timely manner
- Continue to conduct research on the safety of already registered medical devices
- Carry out risk assessments and key monitoring work as required and submit relevant reports
- Cooperate with the MPAs in carrying out medical device adverse event monitoring related work
- The NMPA Legal Agent shall establish an information transmission mechanism with overseas manufacturers to promptly exchange information on the adverse event monitoring and re-evaluation of medical devices
- The NMPA Legal Agent shall be registered as an account user of the National Medical Device Adverse Event Monitoring Information System to directly report any adverse events when required
- Responsible for the maintenance of account user and product registration information in a timely manner
- For any changes made to the product registration information, it should be immediately updated in the system
Timescale for adverse events reporting
We note that this announcement should be read together with the NMPA’s new requirements for periodic risk assessment released on 6 May, and further illustrates the NMPA’s increasing emphasis on post-market surveillance.
By Jacky Li. Contact Cisema to learn more.
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