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Medical device disinfectants and sterilants that don’t meet the definition of an antimicrobial agent are now subject to Canada’s medical device regulations. Read More
The agency also detailed how to comply with the Postmarketing Safety Reporting Rule, noting the rule applies to both combination product applicants and constituent part applicants. Read More
India’s Central Drugs Standard Control Organization is requiring laboratories that test medical devices and in vitro diagnostics to register with the agency. Read More
Revisions to the country’s Therapeutic Products Act and Human Research Act will be followed by a complete overhaul of its Medical Devices Ordinance and a new ordinance for in vitro diagnostics. Read More
The new regulations included a new register of medical devices and the Czech Ministry of Health is now responsible for registering devices and postmarket surveillance. Read More
The Swiss Federal Office of Public Health issued an update on the alignment of the country’s medical device legislation with the new EU requirements adopted early last year. Read More