On May 15, 2020, CMDE released an introduction of the Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program issued by FDA on May 7, 2020. This guideline issued by FDA is to provide an overview of the mechanisms available to submitters through which they can request feedback from or a meeting with the FDA regarding potential or planned medical device Investigational Device Exemption (IDE) applications, Premarket Approval (PMA) applications, Premarket Notification (510(k)) Submissions, etc. more…
On May 11, 2020, NMPA issued a notification that the “Plasma Surgical Equipment” of Hunan Jingyi Medical Technology CO. Ltd is proposed to obtain the green pathway approval. Compared with conventional high-frequency surgical equipment, this product has a lower degree of injury and better postoperative healing. This device can further reduce the treatment cost and economically benefit the patients.
On May 9, 2020, NMPA released seven guidelines for medical device in order 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 their links are listed in the table below. Bradynuoen suggest manufactures to follow the new requirements to do relevant registration. more…
On May 8, 2020, Human Genetic Resources (HGR) Office has publicized the filing status of international collaborative clinical trials, which are filed from April 14, 2020 to April 27, 2020 on human genetic resources in China. As per China GCP Regulation, clinical trial must obtain the HGR filing before official conduction. more…
On May 9, 2020, CMDE issued a notification that the “Fetal Chromosome Non-integral (T21, T18, T13) Detection Kit (semiconductor sequencing)” of CapitalBio Genomics is proposed to obtain the priority pathway approval, because this product is listed in the national key research and development plan. Priority pathway could accelerate the technical review from CMDE and shorten the registration timeline. Bradynuoen could help evaluate and offer support on priority registration.
Link:https://www.cmde.org.cn/CL0004/20875.html
On May 8, 2020, CMDE released the evaluation reports of the two innovative devices: “Reewarm ® PTX” and “Innovation Approval of RNF180 / Septin9 Gene Methylation Detection Kit (PCR Fluorescence Probe Method) ”. Please do not hesitate to contact us if you need these reports.
Link: https://www.cmde.org.cn/CL0116/
On May 8, 2020, CMDE offers suggestions on how to declare dental device accessories, such as dental headpieces and dental motors. For instance, dental headpieces or dental motors conforming to universal interface YY 1012 are recommended to be registered separately from the dental device.
On May 7, 2020, CMDE offers a few tips regarding to the consultation channels it has provided. For example, to improve the quality of supplementary materials, registration applicants can book an online or face to face consultation online before the supplementary materials are submitted officially. CMDE urges registration applicants make full use of the various consultation channels and opportunities so they can submit the whole supplementary materials in one time.
Link: https://www.cmde.org.cn/CL0004/20863.html
On May 7, 2020, CMDE issued a notification that the “Hot Steam Energy Generating System” of Uptake Medical B.V. is proposed to obtain the priority pathway approval, because this product is urgently needed for clinical practice and it has no predicate registered in China yet. Priority pathway could accelerate the technical review from CMDE and shorten the registration timeline. Bradynuoen could help evaluate and offer support on priority registration.
On May 7, 2020, CMDE released an announcement of review results on green pathway for two innovative medical devices, i.e., “Orthopedic Surgical Navigation and Positioning System” and “Blood Flow Guidance Device for Intracranial Aneurysms” from Suzhou Microport Changxing Robot co. Ltd. and AccuMedical respectively.
On April 29, 2020, NMPA released a national annual report on adverse events (AE) surveillance of medical devices. This report focuses on six aspects of the medical devices in China: working process of their AE surveillance; their overall AE report; the statistical analysis of their AE report; information release of AE; their alert release status; and other relevant situations. more…
