Regulation 36
Duty of registrant to ensure compliance with safety and performance requirements
of Health Products (Medical Devices) Regulations 2010
Subsidiary LegislationIn forceProvision 62 of 81
Regulation 36
Amended byS 318/2018 wef 01/06/2018
A registrant of a medical device shall ensure, and maintain objective evidence to establish, that the medical device complies with the safety and performance requirements for the medical device set out on the Authority’s website.