MASEP obtained US FDA pre-market notification
On March 11th, 2005, the MASEP Rotary Gamma Ray Stereotactic Neurosurgery System, obtained the US 510 (K) pre-market notification issued by American Food & Drug Administration (FDA). This creates new opportunity for MASEP to market its product world-wide.
MASEP Medical Science & Technology Development (Shenzhen) Co. had started its application process since March 2002. After months of document preparation the company formally submitted the application to the FDA
on April 28, 2004. FDA is reputed for its strictness in issuing any pre-market notification to large-scale medical device. They scrutinized loads of documents and conducted numerous inquiries lasting for 8 months.
FDA issued a series of new rules for the Market Admittance of medical devices, such as the execution of the review for Risk Management and Software are all new norms being effective recently, which means FDA has greatly strengthened their strictness on their reviews for market admittance of Medical devices. It is under this very situation that the MASEP device has become the first large-scale Chinese device for radiation treatment having clearance of FDA pre-market approval.