IMDRF Mulls Device Single Review Program
The International Medical Device Regulators Forum is making progress in developing a medical device single review program (MDSRP).
Members of the IMDRF’s Good Regulatory Review Practices Working Group gathered in Tokyo following the full IMDRF meeting in Beijing in September and agreed to basic principles for a single review program.
The working group agreed on recognition requirements and procedures for pre-market evaluations. The move marks the first step in developing a MDSRP program among member countries that take different approaches to premarket evaluations.