In a reshuffle of regulatory authorities in China, the FDA will split into separate units for medical products and foods, with medical devices handled by the State Drug Administration within the National Market Supervision Administration (NMSA).
CFDA’s Medical Device Standardization Committee just released a two-year work plan for medical device standards, with plans to revise more than 300 standards by 2020.
The standards will cover technical requirements for development, risk management, quality control and clinical trials.
The Medical Device Standards Management Center will oversee the assessment work.
The revisions are part of ongoing reforms including more stringent medical device standards, improved quality system management and oversight as well as improved inspections (IDDM, Feb. 16).