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
Following the large scale institutional reform in March 2018, declarations for inspection and customs were integrated by China Customs in order to improve efficiency. Since 01.08.2018, enterprises are only required to file one Customs-and-Quarantine Declaration form.
On 01.08.2018, the SDA published the interpretation for the new Medical Device catalogue, which contains some changes regarding classifications. Some Class II products have been upgraded to Class III and some Class III products shall be considered as Class II.
As mentioned in our March/April news: On 13.03.2018, during the 13th National People’s Congress, China’s cabinet decided for the SAMR (State Administration for Market Regulation) to supervise the – CFDA (China Food and Drug Administration), – AQSIQ (General Administration of Quality Supervision, Inspection and Quarantine), and – SAIC (State Administration for Industry and Commerce). The
On 27.09.2018, the CFDA published two Medical Device Regulation Indices (1998-2013) (CFDA WeChat announcement Nr.37. 2018). The first Index includes 114 still valid regulatory documents, covering classifications of specific devices, regulations for non-medical devices, technical guidelines, industry standards, GMPs and post-market penalties. The second Index includes 119 regulatory documents, which are no longer valid.
On 29.09.2018, the CFDA released the “Supervision and Management Regulations of Customised Medical Devices” for public comment. Customized medical devices are personalized products, which meet rare or specific needs of designated patients and are expected to improve the effect of diagnosis and treatment.
On 08.10.2018, the CMDE released new guidelines for the technical review of the sterilization processes of sterile medical devices for public comments. It includes requirements for the preparation of relevant documents as part of the registration of sterile medical devices.
On 30.09.2018, the CFDA published a revised “Clinical Trial Exemption List for Medical Devices and IVDs”, which was immediately implemented (CFDA No. 94-2018). 63 Class II and 21 Class III medical devices, 246 Class II and 31 Class III IVDs were added. The new clinic trial exemption list now contains a total of 855 medical
On 07.09.2018, the CDME added two new functions based on the original online reservation consultation platform for medical devices in review, one is for innovation/priority approval medical device, and the other for clinical trial approval.