On 01.07.2019, the 2018 Drug Review Annual Report was released. Of the grand sum of 9,796 registration applications reviewed and approved in 2018, 7,988 were subject to technical review and 1,808 to direct administrative approval.
On 29.06.2019, NMPA minister Jiao Hong attended a press briefing – held by the general office of the NPCSC (The Standing Committee of the National People’s Congress) – regarding the vaccine administration law. Jiao Hong stated to implement a very strict administration over vaccines. The Law clearly defines a stringent management system, vaccine development, production,
On 31.05.2019, the NMPA released a notice on the definition of drug/device combination products (No. 28 of 2019). It was announced that the definition of product attributes of combination products is now the responsibility of the NMPA Management Center for Medical Device Standards.
On 03.07.2019, the NMPA initiated the Pilot Work Plan for the “Unique Device Identification” (UDI) (No.56-2019), as announced in February 2018. The UDI mark, is made up of a combination of numbers and barcodes. It carries information about the product (i.e. identifying the license holder, the model specification and packaging) and its production (i.e. production
On 31.05.2019 and 06.06.2019, the NMPA (National Medical Products Administration) and CMDE (Center for Medical Devic Evaluation) released three announcements regarding the eRPS (NMPA No. 46-2019; CMDE No. 4-2019; CMDE No. 5-2019). The eRPSystem serves the electronic management of medical device registrations. Starting on 01.11.2019, all documents for class II and III registration, change and
On 05.07.2019 the authority CNCA (Certification and Accreditation Administration of the P.R. China) I published its announcement 34/2019 the decree of the Chinese market regulation authority SAMR (State Administration for Market Supervision). The published decisions are under the umbrella of the efforts of the Chinese State Council to standardize and simplify approval procedures. The official
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
On 14.05.2019, the NMPA (National Medical Products Administration) updated technical review guidelines on the timeline of active medical devices (No. 23-2019). As part of the medical device registration, applicants have to verify their products’ lifespan. The lifespan describes the period in which the safe use of the product is ensured, the product can be used