Monthly NMPA (CFDA) News Roundup covers government announcement, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in May 2021.
Policies
Major Checkpoints for Adverse Event Monitoring Released
NMPA published Checkpoints for Medical Device Registrants and Fillers Conducting Adverse Event Monitoring on April 9, directing the manufacturers for quality management system inspection and adverse event monitoring. The document specifies the checkpoints from four major aspects, institutions and personnel, file management, design development and analysis and measures.
For the full article with the fields that NMPA asks manufactures to pay attention to, please click HERE.
Juvederm’s Lip Filler, China’s First, Approved through Real-World Data Pathway
Juvederm Volbella, indicated for lip enhancement, was approved by NMPA on April 25, 2021. The clinical evaluation enrolling 176 patients was conducted in Hainan utilizing Real-World Data methods.
The Juvederm Volbella injectable gel is for injection into the lips for lip augmentation and for correction of perioral lines in adults over 21. It is the fifth product approved from Juvederm family and the first-of-its-kind filler for lip. click HERE for full article
China Allows Laboratory Developed Test (LDT) Now with Order 739
Article 53 in the Order 739, the “Regulation for Medical Device Administration and Supervision” states that if there is no product of the same type that has China market approval, the eligible medical institutions can develop their own in vitro diagnostic reagents (IVD) based on the clinical needs of the institutions. Such in-house developed IVD reagents can be used in the institutions under the guidance of a licensed physician.” This new regulation relaxes the restrictions on LDTs in China—allowing China medical institutions to develop their own IVD reagents. Click HERE for the full article
Guidelines
AI Software Classification Guideline Asks Feedback
NMPA is now seeking comments to the draft guidance “Artificial Intelligence Medical Software Classification”, due by May 3, 2021. For the full article with the four application directions please click HERE
Five IVD/CDx Related Guidelines Published
The NMPA published “Guideline for Technical Review and IFU Update for Oncology CDx Based on the Same Group of Therapeutic Drugs” on April 7, 2021. Also published are guidelines for rotavirus antigen test, group B Streptococcus nucleic acid test, Human Parvovirus B19 IgM/IgG antibody test, and real-time fluorescent PCR machine. Click HERE for more information
Fast-track Approvals
Abbott, along with Six Domestic Device Makers, Proceeds to Fast-track Review
CMDE granted innovation and priority review status to eight manufacturers in April, by which they can begin the fast-track application process. Click HERE for the complete list