Medical Device (MD) industry is one of the biggest in healthcare, and with innovation and rapid advancement of technologies, currently it is rated as one of the fastest growing industries across the globe. Considering the global market trends, of emerging / developed countries, it is estimated 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, there seems a better fortune for growing investments in MD products for home care, remote monitoring, tele-health and self-monitoring.
A medical device as “an 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.” - WHO
Medical Devices Classification
With the growing demand across the world, however, MD manufacturers must be aware of region-specific Medical Device definition and classifications to approach further for market approvals and registrations. Each country or region has its own criteria for medical device classification and different health authorities have classified medical devices into different segments depending on factors such as complexity of their design aspects, their usage and the potential threat they pose to the body if misused.
Various health authorities across the globe classify their medical devices by order of increasing risk and associated requisite level of control necessary to ensure the safety and efficacy of the device.
know more on HA-specific Classification
US FDA Medical Device Classification
The US Food & Drug Administration (FDA) recognizes three classes of medical devices solely based on the amount of risk that any given medical device poses and the amount of control necessary to assure its safety and efficacy. The Classification goes as:
The Class I medical devices pose minimal threat to the user if mishandled or misused and are a lot simplistic in design in comparison to Class II & III devices. General controls include provisions such as adulteration, misbranding, device registration, listing and good manufacturing practices among others. Examples of Class I devices include enema kit, manual stethoscopes, mercury thermometers, elastic bandages, surgical gloves and hand-held surgical instruments.
Class II Medical Devices are subjected to General Controls and Special Controls as well to assure complete safety and efficacy. The Class II devices are held to a higher of assurance than Class I and more complex in design to effectively perform as indicated without posing any harm to the intended user. Special controls may include special labeling requirements, requisite performance standards and post market surveillance. Examples of Class II devices include powdered wheelchairs, pregnancy kits, infusion pumps, air purifiers and surgical drapes.
This category of medical devices usually help support or sustain life and are substantially important in preventing impairment to human health and have the potential to pose unreasonable risk of illness or injury to the intended user. Since insufficient information exists in this case, such devices need premarket approval and a thorough scientific review to ensure their safety and efficacy. Examples of Class III devices include implantable pacemakers, pulse generators, breast implants and HIV diagnostic tests.
To be aligned with the growing demand, apart from being knowledgeable on specific health authorities’ MD classifications, manufacturers must keep abreast with updated Regulatory requirements, Regulatory pathways, market approval processes etc. otherwise which they may face complexities such as time-consuming processes and raising costs.
Freyr, as a proven Regulatory partner, provides end-to-end Medical Device Regulatory services that span across decoding device classifications, obtaining market approvals, and acting as an in-country representative. We customize the process with respect to service and software assistance for the end-to-end device approvals. With a widely distributed consultant network, Freyr offers a path to approval across multiple jurisdictions.
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.
Freyr guides you in registering the device based on the below required approval procedures for US FDA Region.
- Premarket notification 510(k)
- Premarket approval (PMA)
- De novo petition
- Establishment registration and device listing
Freyr aids in making the approval process easier in European Union and is adept in tackling the multi lingual and complex regulations of different agencies.
- CE Approval
- ISO QMS Certification
- Appointing Authorised Representative
Freyr can accelerate the device approval by getting the licences to market in Canada .
- Medical Device Establishment license (MDEL)
- Medical Device license (MDL)
Medical Device Registration: Emerging countries (APAC)
Device registration process in emerging countries like APAC is a bit complex, read more about the processes for below listed countries.