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Sponsors should list the product’s intended uses, the user base and potential impact on the environment, as well as any skills, knowledge or training needed to properly use the device. Read More
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