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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
In a precedent-setting decision, a federal appeals court ruled that federal statutes on hybrid medical devices — products including components with different… Read More
Brazil’s National Surveillance Agency released an order mapping out the specific oversight roles for federal, state and local ANVISA branches for medical devices. Read More
A four-day FDA inspection of Curasan’s manufacturing facility in Frankfurt, Germany revealed a lack of manufacturing and adverse event reporting procedures. Read More
China’s Food and Drug Administration plans to revise more than 300 standards by 2020, according to a new two-year plan for bringing the country’s medical devices and in vitro diagnostics up to international standards. Read More
Health Canada is sticking to its compliance deadline of Jan. 1, 2019, for devicemakers selling products in Canada to transition to the Medical Device Single Audit Program, but is making adjustments to help small to medium-sized enterprises comply. Read More