Canada
Health Canada, the Canadian regulating authority in the sphere of healthcare products, has issued guidance on summary reports and issue-related analyses for medical devices. Regulatory Background The regulatory requirements for importation, distribution and marketing...
Philippines
The Philippines Food and Drug Administration (FDA), the country’s regulating authority in the sphere of medical devices, has published for public comments and feedback draft guidance on the use of the official portal for applying for licenses required to conduct...
Australia and Oceania
The Therapeutic Goods Administration (TGA or the Agency), the Australian regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to the use of market authorization evidence from comparable...
Uncategorized
Thailand’s Medical Device Control Division has published guidelines on medical device product recalls. The document is intended to assist medical device manufacturers and other parties involved in operations with medical devices in ensuring compliance with the...
Canada
The Health Canada, the Canadian regulating authority in the sphere of medical devices, issued an interim order and guidance document concerning the importation and marketing of medical devices during the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by...
