News
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
NMPA Released a Note about Standardizing the Classification of Medical Devices. On 10.10.2017 the NMPA (China Food and Drug Administration) introduced in its Notice No. 2017/127 a specific work flow for the classification of medical devices, which applies to newly developed medical devices that had not yet been included in the "Medical Device Catalogue". The regulation officially comes into force on 01.08.2018 but experience has shown that it will probably be applied in practice earlier than this.
During the meeting of the Chinese State Council on 20.09.2017, it was decided to extend the CBEC Policy Grace Period for a second time. The regulation allows the introduction of unregistered cosmetics, medical devices, infant formulas and health foods into Chinese cross-border cities until 31.12.2018.
The NMPA published a new classification catalogue on August 31, 2017, with reference to more than 2,000 medical device examples.
China RoHS 2.0 „Compliance Management Catalog“ progressing to next phase.On February 3rd 2016 the responsible authorities (published an update on the regulation for hazardous substances - RoHS 2.0. The regulation is effective since July 1st 2016 (we reported).Originally a „Compliance Management Catalog“ was scheduled for publishing in October 2016. The content should provide a definition, whether a mandatory registration, and possibly an inspection of the manufacturer, will be introduced. So far there was no progress. On July 28th 2017 a consultation of the authority MIIT with business representatives ended. We expect to receive further information about the future approaches for China RoHS by end of this year.For further information please contact:Cisema China Certification GmbHTel.: +49 89 4161 7389 00Fax: +49 89 7484 9956info@cisema.dewww.cisema.de
AQSIQ is planning to introduce an official certificate of clearance for all food imports.On 1.10.2017 announcement 83 2017 issued by AQSIQ (Administration for Quality, Safety, Inspection and Quarantine of China) will come into force. From then on, all food exported to China must be accompanied by an official certificate of clearance, which is to be issued by the competent authorities in the country of origin. Up to now, AQSIQ has not communicated any details, like which authorities are accepted by AQSIQ or which information is to be contained in the certificate.Many of China's trade partners have already filed a note of protest at WTO against this regulation and the feasibility of the Chinese plans is most uncertain according to expert opinions.We shall inform you immediately, if there are any news on the certificate of clearance.For further information please contact:Cisema GmbHTel.: +49 89 4161 7389 00Fax: +49 89 7484 9956info@cisema.dewww.cisema.com
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