Medical Devices
The NMPA announced new administrative measures designed to increase the post-market surveillance applicable to all registered medical devices sold in China.
The principles describe the manufacturing requirements to ensure the medical device operates safely and performs as intended。
AUSSENWIRTSCHAFT AUSTRIA and Cisema cohost the webinar to talk about the regulatory changes for both medical device and cosmetic industries.
Medical devices approved by the NMPA or the Ministry of Food and Drug Safety of Korea can apply for the MDACS listing in Hong Kong within a trial period
The prevention and control work were deployed as the top priority, and the registration process of some overseas medical products was expedited.
NMPA provides a regulatory pathway for CMDs to meet the special clinical demands for medical institutions in China to treat designated patients.
Cisema will submit a proposal to the NMPA about the draft regulation before the consultation period ends on 31.03.2020. If you are interested to contribute, please provide your input to us
On 4.3.2020, the China-Britain Business Council (CBBC) and Cisema held a webinar together to talk about the market, regulations and standards for overseas medical device products to enter the China market. Our business consultant, Anna King, provided an overview of the approval systems for NMPA registration in China and the recent implementation of urgent measures to expedite the approval procedures for medical and health products due to the CoronaVirus outbreak.Watch the recording of the webinar on Youtube.
Currently, there are 14 municipalities with the capacity to file non-special purpose cosmetics, and Cisema can guide you through the MPA filing process.
The Ministry of Commerce announced the list of intermediary services and administrative examinations and approvals for import and export of goods in China.
Cisema has the capability to help you comply with Hong Kong MDACS requirements and expand your businesses in the Greater Bay Area
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 clinical trial exemption list won’t require completion of clinical trials in order to achieve NMPA certification.This new clinical trial exemption list is effective since the date of announcement on 20th December.Feel free to contact us if you would like to know what products were included in the clinical trial exemption list for medical devices, and the clinical trial exemption list for IVDs.
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