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
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