Medical Devices Regulatory Services, US FDA, Europe, Canada, APAC

Medical Devices Regulatory

The Medical Device (MD) industry is one of the biggest in healthcare, and with innovation and rapid advancement of technologies, it is currently rated as one of the fastest growing industries across the globe. Considering the global market trends of both emerging and developed economies, it is believed that the demand for medical equipment is undergoing a strategic change with the focus shifting towards prevention from diagnosis. With the increased focus on preventive care, MD products for home care, remote monitoring, tele-health and self-monitoring are proving to be very good investments.

A medical device, according to the World Health Organisation (WHO), is defined as, “any article, instrument, apparatus or machine that is used in the prevention, diagnosis or treatment of illness or disease, or for detecting, measuring, restoring, correcting or modifying the structure or function of the body for some health purpose.”

Services Offered

Freyr offers the following end-to-end Regulatory services for medical devices:

• Medical Device Classification

• Good Manufacturing Practice (GMP) Compliance & Remediation Services

• Representation and Distributorship Services

• Documentation and Dossier Compilation Services

• Global Regulatory and Market Intelligence

Medical Devices Classification

With the growing demand for medical devices across the world, MD manufacturers must be aware of region-specific definitions of the term, ‘Medical Device’ as well as various kinds of medical device classifications. This is necessary in order to pursue market approvals and medical device registrations. Each country or region has its own criteria for medical device classification and thus different Health Authorities (HAs) have classified medical devices variously, depending on factors such as the complexities of their designs, their usages and the potential threats they pose to the body if misused.

Various HAs across the globe classify their medical devices in order of increasing risk and the associated requisite levels of control necessary to ensure the safety and efficacy of the device.

Medical Device Registration - Specific Geographic Markets

Freyr has gained market approval for hundreds of medical devices of varied market clusters like US FDA, EMEA, GCC and APAC.