The unapproved devices can be clinically used in Hainan to collect real world data (RWD) and support its regulatory approval from NMPA. Under the policy, the scale-up usage and clinical data collection plan for Juvéderm VOLUX, an Allegan manufactured injectable dermal filler, was launched in Hainan Boao Medical Pilot Zone on July 3, 2020. more…
In responding to the COVID-19 epidemic, all countries urgently established their green pathways for the emergency approval of medical devices. Both the medical device emergency approval process in China and EUA authorization in the US are special evaluation systems established in response to major emergencies. Both have similarities and differences, as shown in the table below. more…
On June 28, 2020, the implantation of Artificial Iris produced by a German company – Human Optics is completed in Boao Lecheng, which is the first Artificial Iris implant operation in China. This Artificial Iris implant product is recently imported from the German company – Human Optics based on an Early and Pilot Implementation policy in Lecheng, Hainan. more…
On June 29, 2020, CMDE issued a notification about the “Intelligent Diagnosis System for Child Growth and Development” made by YITU is proposed to obtain the priority pathway approval, because this product is specially designed for children, and is a medical device with obvious clinical advantages. Priority pathway could accelerate the technical review from CMDE and shorten the registration timeline. China Med Device could help evaluate and offer support on priority registration.
Link: https://www.cmde.org.cn/CL0004/21190.html
On July 9, 2020, NMPA released 41 approved medical device industry standards and 2 approved medical device industry standard amendments. Please email info@inspirativemed.com for the details about the standards and amendments. more…
On July 9, 2020, NMPA released Six guidelines for medical devices to strengthen the surveillance and guidance of the registration of medical device products and further improve the quality of registration review. All the new guidelines and links are listed in the table below. more…
In June, 2020, the General Office of the State Council has released the State Council’s Legislative Work Plan for 2020, which includes two regulation compilation related to NMPA. The two regulations are Regulation on the Supervision and Administration of Cosmetics and Regulation on the Supervision and Administration of Medical Devices. more…
On July 8, 2020, NMPA released the China Medical Device Standards Management Annual Report (2019). This report elaborates the development of the medical device standards in China. For instance, the number, coverage and reasonable degree of classification of the standards is increased. more…
On June 6, 2020, NMPA released the IFU (instructions for use) Compiling Guidelines on Rigid Gas Permeable Contact Lenses for Orthokeratology (2020 Revision) in order to further improve the quality of registration and review. This guideline is a revision based on the current regulations, more…
In July 7, 2020, CMDE released a notice about the change of registration information related to the applicants during the registration process. This notice involves two situations of the changes: 1) the change of CA certificate; 2) the information change of the applicants during the technical review process. more…
On July 7, 2020, CMDE announced its preparation of Technical Review and IFU (instructions for use) Updating Guidelines of Tumor CDx Based on Similar Therapeutic Drugs (Draft).
These guidelines are drafted based on the 2020 Annual Medical Device Registration Technical Guidelines Revision Plan made by NMPA. more…
