August 6, 2020
Oncology biomarker testing, as an important tool to guide the treatment of targeted therapy, has been one of the hottest areas for IVD manufactures world-wide. BRAF gene mutations are one […]
July 28, 2020
A Periodic Risk Evaluation Report (PRER) is required to submit to NMPA, depending on the initial NMPA registration time, according to Decree No. 1 Administrative Measures of Medical Device Adverse […]
July 28, 2020
In March 2018, the transformation from CFDA to NMPA, which emerged into State Administration for Market Regulation (SAMR), was to make the linkage between pre-market approval and post-market surveillance, to […]
July 28, 2020
NMPA published 14 guidelines in July 2020. The guidelines cover indications of ophthalmic, orthopedic, gastroenterology and urology, anesthesia and immunology, etc. Full List of Guidelines General Technical review guideline on […]
July 28, 2020
A Periodic Risk Evaluation Report is required to submit to NMPA, depending on the initial NMPA registration time, according to Decree No. 1 Administrative Measures of Medical Device Adverse Event […]