Policies
NMPA Resumes Overseas On-Site Inspections After COVID-19 Pause
The NMPA released the results of two overseas inspections on October 8, 2024, which revealed noncompliance in two South Korean manufacturers. This marked the resumption of overseas on-site inspections of imported medical devices, following a halt in 2020 due to the COVID-19 pandemic.
The NMA conducted inspections of two Korean aesthetic implant companies, SDM Co., Ltd. and Search Medical Co., Ltd. The focus was on their Class III medical devices, specifically dental implants and e-PTFE facial implants. For the inspection results and penalties, please click HERE
Overview of China Registration and Development Status of Pediatric IVD Reagents
The NMPA Center for Medical Device Evaluation (CMDE) published an article on pediatric In vitro diagnostic (IVD) on October 21, 2024.
Pediatric IVD reagents in China address genetic and pediatric-specific diseases across age groups from neonates to 18-year-olds. Approved products include tests for pathogenic antigens, antibodies, nucleic acids, blood typing, and genetic screenings for hereditary conditions like spinal muscular atrophy and metabolic disorders. Despite high demand, many IVD products for rare diseases and genetic disorders remain in short supply. For more information with prioritization regulatory policies, please click HERE
Guidelines & Standards
Thirty-Four Standards Issued in One Day
Thirty-four newly established or revised industry standards were released on October 8, 2024, to guide manufacturers for type testing, pre-clinical, clinical studies, and regulatory submissions. The mandatory standards include those for resin-modified cement, blood perfusion equipment and electric gastric lavage machine. For the list of mandatory and recommended standards, please click HERE
Fast-Track Approvals
Review Report Released for CryoLife’s Surgical Adhesive
The NMPA granted innovation approval to CryoLife, Inc’s BioGlue Surgical Adhesive and issued a review report. The product is intended for open surgical repair of large blood vessels (such as the aorta, femoral artery, and carotid artery) in adult patients and can be used as an adjunct to standard hemostasis methods, such as sutures and needles.
The review report has four sections: product overview, pre-clinical, clinical and risk-benefit analysis. For the outline of the report, please click HERE
