On 11.02.2020, the Israel Export Institute co-hosted a webinar together with Cisema. In this webinar, the China administration bodies, regulations and standards for cosmetics were introduced by our business consultant, Anna King, as well as a presentation of the important prerequisites for NMPA registration in China. An overview of the approval systems for special and
On 20.12.2019, the China NMPA (National Medical Products Administration) announced (No.91-2019) that it would add 148 medical devices and 23 in-vitro diagnostic reagents to the clinical trial exemption list, as well as to revise the names and descriptions of 48 medical devices and 4 in-vitro diagnostic reagents. Medical devices and in-vitro diagnostic reagents on the
The China NMPA (National Medical Products Administration) is seeking input on whether real world data can be used for Clinical Evaluation Reports. This is a potentially very significant development and Cisema will submit a proposal to the NMPA before the consultation period ends on 13 January 2020. Please provide to us your opinions on the
On 22.11.2019, China’s NMPA (National Medical Products Administration) announced a draft regulation concerning overseas inspection for cosmetic products, and launched the public consultation to receive feedback. According to the proposed regulation, it aims to introduce, standardize and optimize the inspection process. Once adopted, inspections on foreign manufacturers are required to be conducted by Chinese authorities
Medical Devices Regulation in China Seminar Date: 28.11.2019 Time: 08:30 – 14:00 City: Tel Aviv Location: The Israel Export & International Cooperation Institute, 29 Hamered St. Tel Aviv, Fifth floor Organiser: The Israel Export & International Cooperation Institute Registration: Click here to register Contact Person: Tomer Epstein, Tel. +972(3)5142938 Stefan Fischer and Anna King, from
On 10.09.2019, the NMPA (National Medical Products Administration) announced changes to the procedures regarding cosmetics sample tests in China (No. 72-2019), followed by an interpretation of their announcement on 12.09.2019. Laboratories – that perform sample tests for cosmetics NMPA approval – need to re-apply for their qualification as a testing institutions because the relevant qualification
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.