Uncategorized
The Health Sciences Authority (HSA), Singapore’s medical device regulating authority, has published the new revision of the guidance on medical device field safety corrective actions. General Overview of the Field Safety Corrective Action The recent guidance...
Uncategorized
To assist medical device manufacturers in maintaining compliance with applicable requirements, the National Health Regulatory Authority (NHRA), the Kingdom of Bahrain’s agency responsible for medical device regulation, has published registration guidelines. Bahrain...
South America
The National Administration of Drugs, Foods and Medical Devices (ANMAT), Argentina’s regulating authority in the sphere of medical device circulation, has recently issued the updated rules regarding the registration of medical devices. The most important amendments...
Uncategorized
The Medical Device Authority (MDA), a special division of the Ministry of Health Malaysia responsible for medical device regulation, has announced new rules introducing additional obligations for medical device manufacturers and other parties involved in medical...
Uncategorized
Health Canada, the Canadian medical device regulating agency, has issued new guidance on software as a medical device (SaMD) to provide details on definition and classification. The Scope of the Guidance The new guidance describes certain aspects of the...
Uncategorized
ISO, the International Organization for Standardization, issued a new standard dedicated to the application of risk management to medical devices. Brief Overview of ISO standards ISO is an organization comprised of several national standards bodies. The...
RegDesk is recognized as a Regulatory Intelligence Representative Vendor! Learn more by reading the 2024 Gartner® Market Guide for Regulatory Intelligence Solutions.
Get the report
