Medical Device Regulation and Compliance Process in the USA: A Complete FDA Guide
FDA grants or approves a device through a premarket submission and it separately registers the manufacturing establishment and lists the […]
EU Medical Device Recognition in India
India now allows eligible medical devices approved in the European Union to be considered for a waiver from submitting clinical
UK AI Medical Device Regulation and Reforms
In the UK, AI medical devices fall under the Medical Devices Regulations 2002 (UK MDR 2002). The Medicines and Healthcare
Regulatory Requirements for Medical Device Sterilization in India
Three obligations are taken on by a manufacturer that supplies a sterile device in India. The process has to be
Medical Device Regulations and Registration Process in Canada
Medical device registration Canada is not one process. Health Canada issues two separate licences. A medical device licence (MDL) covers
FDA PMA eSTAR Draft Guidance: What Sponsors Need to Know
On September 18, 2026, FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER)
Medical Device Regulations & Registration Process in Argentina
Medical devices sold in Argentina are regulated by ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica). ANMAT requires two
FDA CDRH Annual Reporting Requirements for Laser Products
Manufacturers often assume that making a laser product means an annual FDA filing. That assumption is wrong. The obligation depends
Medical Device Regulations and Registration Process in Switzerland
Expanding into the Swiss medical device market requires more than EU MDR or EU IVDR compliance. Manufacturers must also meet