Medical Devices
Customized medical devices are expected to improve the effect of diagnosis and treatment for designated patients as personalized products.
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.
On 30.09.2018, the NMPA published a revised “Clinical Trial Exemption List for Medical Devices and IVDs”, which was immediately implemented (NMPA No. 94-2018). 63 Class II and 21 Class III medical devices, 246 Class II and 31 Class III IVDs were added. The new clinic trial exemption list now contains a total of 855 medical devices and 393 IVDs.
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 13.08.2018, the Chinese NMPA released the “Measures for Monitoring and Reassessing Adverse Events of Medical Devices” (NMPA Decree No. 1), which will take effect on 01.01.2019. The main purpose of this new regulation is to strengthen the post-marketing supervisions, such as monitoring of medical device adverse events and re-evaluation of the approved medical devices. It also clarifies the responsibilities of NMPA Legal Agents and medical device manufacturers. According to the new regulation, the manufacturer shall conduct continuous research on the medical devices that are already approved in order to evaluate risks and monitor adverse events. The regulation also lists penalties in case the manufacturer fails to comply with the regulation.
On 12.09.2018, the CMDE (Center for Medical Device Evaluation) announced that they will provide a pre-reviewing service for supplementary documents of medical device starting 08.10.2018 (CMDE No. 08-2018). This service will be available for domestic Class III, as well as imported Class II and III medical devices if it is the first NMPA (China Food and Drug Administration) registration in China. With this service, CMDE aims to ensure that the prepared supplementary files fulfil the requirements as they can only be submitted once after the receipt of the corrective notice.
On 21.11.2018, Premier of the State Council, Li Keqiang, announced the extension of Cross-Border-E-Commerce (CBEC) beyond 31.12.2018. CBEC enables companies to sell certain products (e.g. cosmetics) to customers in China on dedicated online platforms without NMPA (former NMPA) certificate. Moreover, CBEC experimental zones were extended from 15 to 37 cities, such as Beijing, Shenyang, Nanjing, Wuhan, Xi'an and Xiamen. 63 new items were added into the “CBEC retail import list”, containing those products, which are not subject to import tariffs and solely require 70% of the applicable VAT and consumption taxes. Furthermore, the single purchase limit was raised from RMB 2,000 to RMB 5,000 and the annual transaction limit was raised from RMB 20,000 to RMB 26,000 per person per year.
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 04.11.2018, the new official website of NMPA (National Medical Products Administration) - former NMPA (China Food and Drug Administration) - was activated (https://www.cfda.gov.cn/). There are no significate changes regarding the content and functions of the website.
On 17.11.2017 the NMPA (China Food and Drug Administration) published a notice announcing that fee-charging tests (also referred to as sponsored tests) are accepted as part of the NMPA registration of medical devices (No. 2017-187).
Cisema gave a talk on medical device registration as part of the webinar on hosted by the U.S. Commercial Service on December 13, 2017.
Enhanced Acceptance of Foreign Clinical Trial Data. On 08.10.2017, the CPC Central Committee and State Council published “Deepening the Reform of the Examination and Approval System and Encouraging the Innovation of Pharmaceutical and Medical Devices (Draft for Comment)”. According to this, NMPA plans to accept foreign clinical trial data if it complies with Chinese requirements.NMPA comments on the following aspects of clinical trial management:
- Speeding up the review and approval of market entry
- Promoting drug innovation and generic drug development
- Strengthening the lifecycle management of pharmaceutical and MD
- Improving technical support
- Strengthening organization and implementation
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