Medical Devices

Online Trade - Deliveries Classified as Products for Personal Use.As of 1^st January 2018 the Chinese customs authorities will treat all commodities traded through CBEC as articles for personal use. The reason is that commodities traded through CBEC are for private persons and usually have a low value and low quantities.Another five pilot cities for CBEC will be nominated: Besides Hangzhou, Tianjin, Shanghai, Chongqing, Zhengzhou, Guangzhou, Ningbo,Shenzhen, Fuzhou und Pingtan, there will now be added Chengdu, Dalian, Qingdao, Suzhou und Hefei.More details for the supervision will be published shortly. It can be assumed, however, that certain product groups which normally need registration or certification, can be traded and imported freely through CBEC. Among these commodities are:Ordinary cosmetics such as lotion, cream, facial mask, shampoo

• Nutritional supplements such as vitamin and mineral preparations
• CCC products such as coffee machines, vacuum cleaner
• Freely traded medical devices such as electronic sphygmomanometer

It has not been decided yet if the new regulation also applies to infant formula.Further information on this topic can be obtained from:Cisema GmbHTel.: +49 89 4161 7389 – 00Fax: +49 89 7484 9956info@cisema.dewww.cisema.com

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.

NMPA Issues Charging Standards for Drug and Medical Device RegistrationOn May 27, the China Food and Drug Administration ("NMPA") released its “Charging Standards for Registration of Drugs and Medical Devices” which come into force immediately. For pharmaceuticals, foreign companies will have to pay for clinical trials or marketing approvals, medical device companies have to pay for class II and III registration. This applies to new and change applications as well as the extension after five years.For small to micro enterprises in China doing medical innovation, the NMPA has set up a preferential policy of waiving registration fees and supplementary application fees.For more information please contact us at:Cisema China Certification GmbHTel.: +49 89 4161 7389 - 00Fax: +49 89 7484 9956info@cisema.dewww.cisema.com

Recalls of Medical Device Regulation Updated .On September 2nd 2016 a new draft for handling recalls of medical devices has been released. The revision will replace the current regulation 82/2010 from the Chinese Ministry of Health dated 28.06.2010. It describes the key points leading to a recall.

1. If the medical device poses hazardous risks
2. If the medical device does not meet the regulation standards
3. If during manufacturing and/or distribution violations of the current medical device regulations occur
4. If any further adverse events ask for a recall

The draft also gives some guidelines for the management of recalls.

1. When the recall occurs outside of China the appropriate departments of the NMPA have to be informed
2. Within China:- Monitoring the safety of medical devices- Communication, reporting and close cooperation with the NMPA- Organization of the recall – assessment, if applicable relabelling, modification of the quality manual and/or software up-grades. Also of course repairs or replacement of the device and its disposal have to be taken care of.- Compensation- Penalties

When there is proof of the defectiveness of the device, and the NMPA-Legal-Agent fails to report to the NMPA, the NMPA may initiate the recall.Violation of the regulations can result in fines for the NMPA Legal Agent or even cost him his license.Recalls will be published in the NMPA database stating details of the product, its manufacturer and NMPA Legal Agent.For more information please contact us:Cisema GmbHTel.: +49 89 4161 7389 – 00Fax: +49 89 7484 9956info@cisema.dewww.cisema.com