On May 29, 2020, an article was published by CMDE after a seminar about the real world data (RWD) applied for clinical evaluation of medical devices. This article further emphasized the importance of the Technical Guidelines of Real World Data for Medical Device Clinical Evaluation for the registration applicants and regulatory authorities. more…
In April, 2020, NMPA has approved a total of 235 medical devices. 134 of them are domestic Class III medical devices, 38 of them are imported Class III medical devices, 62 of them are imported Class II medical devices and 1 of them is a Taiwan medical device. more…
On May 25, 2020, NMPA released a list of epidemic prevention medical device inspection and testing institutions with national qualification. 63 institutions are on the list and most of them are able to test the disposable medical protective gowns, medical face masks, medical surgical masks, disposable sterile rubber surgical gloves, etc. Please email info@inspirativemed.com to get the list of the institutions mentioned above and Bradynuoen can help you evaluate their possible impact to your products.
On May 25, 2020, NMPA released an announcement of medical device sampling inspection results. Recently, NMPA has conducted quality inspection on 6 kinds of products such as Doide laser systems, glucose detection kits, soft contact lens, etc. and a total of 24 batches (sets) of products do not conformity with the standards. Please email info@inspirativemed.com to get the list of products not in conformity with the standards in this NMPA audit and Bradynuoen can help you evaluate their possible impact to your products.
In May 2020, National Center for ADR Monitoring, China released a further description for the regular risk assessment report implementation of medical device adverse events, which elaborates the time and data collection range of regular risk assessment report on medical devices. Please email info@inspirativemed.com to get the detail information. more…
On May 20, 2020, Human Genetic Resources (HGR) Office has publicized the filing status of international collaborative clinical trials, which are filed from April 28, 2020 to May 11, 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 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
