On May 21, 2020, CMDE issued a notice to collect comments on The Guidelines for Technical Review of Human Factor Design of Medical Devices (Draft). Any of the suggestions or opinions shall be submitted by June 26, 2020. Bradynuoen can help manufacturers to evaluate the gap between your products and new guidelines and submit the comments of manufacturers to CMDE.
On May 21, 2020, CMDE released an announcement of review results on green pathway for two innovative medical devices, i.e., “Renal Sympathetic Ultrasound Denervation System” and “Cross-linked Polyethylene Aspheric Lens” from ReCor Medical Incorporated and Pillarbio respectively.
On May 19, 2020, NMPA released an Evaluation Guidelines for Raw Material Changes of Passive Medical Device Products in order to strengthen the surveillance and guidance of the registration of medical device products and further improve the quality of registration review. Bradynuoen suggest manufactures to follow the new requirements to do relevant registration.
On May 19, 2020, NMPA released a notice about a compiling and amending plan for 2020 medical device industry standards. This notice lists the medical device standards which may undergo the compiling and amending in 2020. Please email info@inspirativemed.com to get the list of medical device standards to be updated and Bradynuoen can help you evaluate their possible impact to your products.
Link: http://www.nmpa.gov.cn/WS04/CL2197/377522.html
On May 18, 2020, CMDE released a notice about Certificate Authority (CA) updates for the registration of medical devices by electronic Regulated Product Submission (eRPS) system, which means that CA holders can extend the validity of the CA certificate for one year by means of online operation and no extra payment is required.
Link: https://www.cmde.org.cn/CL0004/20925.html
On May 15, 2020, NMPA released the Guidelines for Technical Review of Dengue Virus Nucleic Acid Amplification Test Reagents in order to strengthen the surveillance and guidance of the registration of medical device products and further improve the quality of registration review. Bradynuoen suggest manufactures to follow the new requirements to do relevant registration.
Link: http://www.nmpa.gov.cn/WS04/CL2138/377444.html
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
