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.
Stefan Fischer is a trusted partner of Advantage Austria, Foreign Trade Center of the Austrian Federal Economic Chamber. For export to China or local production for the Chinese market, depending on the product, certain certifications or approvals may be made, such as: China Compulsory Certification (CCC) or China Food and Drug Administration (CFDA). The webinar
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.
On 26.07.2018, the SAMR has released a draft for public comment on technical guidelines for formula changes of infant formula milk powder. As long as the type of raw materials, the order of ingredients and the table of nutrients remain the same, food raw materials and food additives are allowed to reasonably fluctuate within a