On March 13, 2020, NMPA updated the new regulation: Measures for the Management of Medical Device Quality Audit. Meanwhile, the Administrative Regulations on Quality Supervision and Audit of Medical Devices (食药监械监[2013] No. 212) and the National Medical Device Audit Work Procedure (食药监械监[2014] No. 213) issued by NMPA shall be abolished. The new regulations include seven chapters: general rules, protocols, audit sampling, audit management and report delivery, re-inspection and disposal, surveillance and management, and supplementary provisions. China is enhancing the post-market surveillance since the latest two years. Bradynuoen as a qualified legal agent of overseas manufacturer can help the communication with NMPA, handle AE, recall, inspection etc.
Human Genetic Resources (HGR) Office has publicized the filing status of international collaborative clinical trials, which are filed from February 18, 2020 to March 2, 2020 on human genetic resources in China. As per China GCP Regulation, clinical trial must obtain the HGR filing before official conduction.
Link: http://www.cncbd.org.cn/Notice/Detail/9212
If you want to know more about your device category, clinical pathways, predicate information and other related to your China business, please do not hesitate to contact us info@inspirativemed.com. more…
On March 12, 2020, NMPA released a notice about collecting and compiling guidelines, Biological Evaluation of Medical Devices Part 2: Biological Tests, of biological tests for medical devices, which can be participated by all parties, such as related testing institutions, manufacturers and research institutes. Relevant comments shall be submitted by March 31, 2020. Bradynuoen can manufactures submit their comments and requirements if needed. info@inspirativemed.com
On March 12, 2020, NMPA has approved a total of 37 imported medical devices listed in the following table. But all these certificates are renewed, not the initial registration. If you want to know more about your device category, clinical pathways, predicate information and other related to your China business, please do not hesitate to contact us info@inspirativemed.com.
On March 11, 2020, NMPA emergency approvals have been granted to a new 2019-nCoV IgM antibody assay reagents (colloidal gold method) from Hecin Co., Ltd. Up to now, a total of 10 2019-nCoV nucleic acid assay reagents and 6 antibody assay reagents have been approved under emergency situation.
On March 10, 2020, NMPA released nine 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. info@inspirativemed.com
On March 6, 2020, NMPA announced that 24 medical device industry standards and 6 medical device industry standard amendments have been approved. Details about the standards and amendments are listed in the table below for your reference. Bradynuoen can help manufacturers to evaluate the gap between your products and new guidelines. info@inspirativemed.com
On March 3, 2020, CMDE has publicized the Review Key Points of CT Imaging Assisted Triage and Evaluation Software for Pneumonia (Trial) to deal with the emergency situation of COVID-19. China is increasingly encouraging the AI related software to help improve doctor’s diagnostic efficiency. NMPA has published software related guidelines for registration. Please feel free to contact us if you need any copy via info@inspirativemed.com.
Link: https://www.cmde.org.cn/CL0004/20526.html
On March 6, 2020, NMPA emergency approvals have been granted to a new 2019-nCoV antibody assay reagents (CMIA) from Xiamen Innodx Biotech Co., Ltd. Up to now, a total of 10 2019-nCoV nucleic acid assay reagents and 5 antibody assay reagents have been approved under emergency situation.
Link: http://www.nmpa.gov.cn/WS04/CL2056/375351.html
On March 5, 2020, NMPA has granted the registration certificate of Bio Absorbable Sirolimus-eluting Coronary Stent (SES) from Shandong AWA Biopharm Co. Ltd. Compared with traditional metal drug stents, this product has more advantages, e.g., the final degradation products of the stent are water and carbon dioxide to reduce late thrombosis. Bradynuoen has extensive experiences in cardiovascular registration and clinical trial. Please feel free to let us know any challenges for China entry. info@inspirativemed.com
Link: http://www.nmpa.gov.cn/WS04/CL2056/375297.html
NMPA issued a notice to collect comments on Imported Registered Medical Devices Transferred to China Manufacturing (draft) on March 5, 2020. The registrant of imported medical device can establish an entity with foreign investment for applying domestic registration certificate. The imported medical device registration can be transferred to domestic device registration. Some of imported device registration dossiers can be used for domestic registration as equivalence. This draft can pave the way for overseas companies to execute China local manufacturing.
CMDE issued a notice to collect comments on The Guidelines for Clinical Evaluation of Imaging Ultrasound Equipment (draft) on March 5, 2020. Bradynuoen can help manufacturers to evaluate the gap between your products and new guidelines and submit the comments of manufacturers to CMDE.
