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.
On March 5, 2020, NMPA released seven guidelines of technical review for registration on IVD instrument and assays:
GE Healthcare Finland Oy and Datex-Ohmeda, Inc voluntarily recalled its Patient Monitor and two anesthesia systems due to the breathing module sensor may be invalid. Relevant recall information has been released with Recall Level 2 on November 4, 2019, but now the recall level is changed to Level 1. Recall Level 1 is the most serious case. Since China NMPA enhances the post-market surveillance, Bradynuoen can help manufacturers handle AE and recalls in compliance to China regulations. more…
We often encounter the word “agent” when registering medical devices no matter at home or abroad. What exactly does it mean and what is required of an “agent”?
Here are the relevant requirements for medical device “agents” in Chinese, US and European regulations.
On February 25 and 26, 2020, NMPA announced that 13 new medical device industry standards have been approved as well as a medical device industry standard amendment. Details about the standards and amendment is listed in the table below for your reference. Bradynuoen can help manufacturers to evaluate the gap between your products and new guidelines.
