Regulatory News from Across Asia-Pacific
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 October 30, 2018, the NMPA issued guidelines for the approval of clinically urgent new drugs covering the procedure, requirements, etc.
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.
Before November 2018, foreign manufacturers had to the choose between NMPA Registration in Beijing or Filing in the 11 Pilot New Trade Zones
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.
The Chinese authorities CNCA and SAMR announced on 03.12.2018 that several product groups will no longer be subject to CCC certification...
For products that are no longer relevant for CCC (Chinese product safety certification) since June 15, 2018, new guidelines for voluntary certification have been published. Specifically for brake hoses/pipes, fuel tanks and fanfare for motor vehicles; motorcycle engine and e-bikes.
On 15.06.2018 the authorities SAMR and CNCA published in their announcement 11/2018 that for some product groups the mandatory certification according to CCC (China Compulsory Certification) is lifted and some others are going to be converted into a manufacturer's declaration.
On 15.3.2018 the certification authority CNCA (Certification and Accreditation Administration of the P.R. China) announced on short term (announcement 10/2018) that the issuance of Permissions of Printing (PoP) for marking products with the CCC-logo (China Compulsory Certification) will be stopped as of 20.03.2018. According to the announcement, the owners of CCC certificates can start the marking immediately after receipt of the CCC certificate, provided they adhere to the guidelines. This procedure is similar to other well-known certification marks like E, CE or UL.
On 05.02.2018, the NIFDC (National Institutes for Food and Drug Control) – a unit under the NMPA (China Food and Drug Administration) – published a draft on two alternatives to animal testing: One for skin and one for eye irritation. The draft was open for public comment until 15.02.2018 and clearly indicates a major step towards the improvement of China’s technical cosmetics regulations and the replacement of animal testing in the future.
The CNCA (Certification and Accreditation Administration of the People's Republic of China) announced with its Notice No. 43-2017 that the CAQC (Cyberspace Administration of China) is allowed to process CCC (China Compulsory Certification) certification for product groups in the automotive sector.
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.
Cisema celebrates its 15th annversary: Over the years Cisema has developed a range of services with the main focus on certification, registration and licensing in the People's Republic of China. Since China’s WTO accession, the Chinese government has made great efforts to adapt non-tariff trade barriers to international guidelines.
Starting August 1st 2018 motorcycle helmets, electric blankets, heating pads and similar flexible heaters required the CCC certification of the P.R. China.
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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