News

In the article A fortunate opportunity? Navigating Chinese regulation challenges to ensure success Anna Fischer from Cisema Hong Kong sets out the key challenges that foreign manufacturers of medical devices face in obtaining approval for and access to the Chinese market. Read the article on MedTech ENGINE.

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.

Following the large scale institutional reform in March 2018, declarations for inspection and customs were integrated by China Customs in order to improve efficiency. Since 01.08.2018, enterprises are only required to file one Customs-and-Quarantine Declaration form.

On 01.08.2018, the SDA published the interpretation for the new Medical Device catalogue, which contains some changes regarding classifications. Some Class II products have been upgraded to Class III and some Class III products shall be considered as Class II.

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 27.09.2018, the NMPA published two Medical Device Regulation Indices (1998-2013) (NMPA WeChat announcement Nr.37. 2018). The first Index includes 114 still valid regulatory documents, covering classifications of specific devices, regulations for non-medical devices, technical guidelines, industry standards, GMPs and post-market penalties. The second Index includes 119 regulatory documents, which are no longer valid.

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 06.09.2018, the NHC (National Health Commission) issued a draft of 11 national food safety standards for public comments (NHC No. 780-2018). On 12.09.2018, the NHC published a revision draft of the GB standard legislation program (2018) for public comment, covering 62 national food safety standards (No. 795-2018). Both announcements address many test methods.Note: The Chinese term Guobiao (GB) means national standard.

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.