From Mai 14 – 17, 2019, the spring CMEF (China Medical Equipment Fair in Shanghai) 2019 in Shanghai, China, took place. Cisema’s Account Management team used this opportunity to meet, as well as to deepen our contacts with customers, associations and chambers present at the fair and to establish new contacts with customers. If you
If you have a medical device and want to get it into the Chinese healthcare market you will need to get it certified. In this episode of UK Export Advice, David James talks to Anna Fischer from CISEMA, a business that helps Western companies get their products certified in China. Click here to listen to
On 13.03.2019, the SAMR (State Administration for Market Regulation) released new review measures for advertisements for pharmaceuticals, medical devices, health foods, and food for special medical purpose. The draft is open to public comments.
On 22.03.2019, the NMPA (National Medical Products Administration – former CFDA) released an announcement on 9 cosmetics test methods (NMPA No. 2019-12), which will be relevant for cosmetics registration, filing, and supervision and inspection starting January 1, 2020. Five testing methods of the “Cosmetic Safety Technical Specification (2015 edition)” were revised and four were added.
On 18. February 2019, the Chinese market supervisory authority SAMR (State Administration for Market Regulation of the Peoples Republic of China) announced further measures and regulations in the area of special and pressure equipment. A simplification is being sought, similar to the one already initiated for the CCC (China Compulsory Certification) in 2018. This affects
On 16.01.2019, the Chinese market supervisory authority SAMR (State Administration for Market Regulation of the Peoples Republic of China) published that “Pipes for Pressure Lines” and “Pressure Valves” are to be included in the catalogue for goods subject to licensing under the Chinese Manufacturer License (CML in short; similar to AD 2000 and ASME; also
On 14. February 2019, the Chinese market surveillance authority SAMR published for download a draft of the new “TSG 07 Regulation for licensing manufactures of special equipment” (freely translated from the Chinese name; the downloadable document also states in English: “Regulation for production unit licensing of special equipment”). The draft of the new standard consolidates a large
The authority SAMR published on January 29, 2019 in a “City Supervision Letter” (freely translated from the Chinese “市监特设函”) with the document no. 195/2019 additional provisions on the transition period of new standards and specifications on measures to improve the safety monitoring of pressure equipment (including gas cylinders) in the P.R. China. This is also a response