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.”
Freyr offers the following end-to-end Regulatory services for medical devices and In-vitro Diagnostics:
- Medical Device Classification
- Good Manufacturing Practice (GMP) Compliance & Remediation Services
- Representation and Distributorship Services
- Medical Device Technical File Compilation
- Medical Device Master File Compilation
- Global Regulatory and Market Intelligence
- Medical Device Labeling and Review
Medical Device 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. While In Vitro Devices (IVDs) are generally considered as a sub-section within medical devices, not all authorities concur on that understanding. There are special regulations in place for IVDs for some regions, called IVD Regulations (IVDR). In such scenarios, IVDR classification and similar regulations must also be taken into consideration.
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.
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. This classification is as follows:
Class I medical devices pose minimal threat to the user if mishandled or misused and are very 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 kits, manual stethoscopes, mercury thermometers, elastic bandages, surgical gloves and hand-held surgical instruments.
Class II Medical Devices (MD) 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 degree of assurance than Class I and more complex in design in order to effectively perform as indicated without posing any harm to the intended user. Special controls may include special medical device labeling requirements, requisite performance standards and post market surveillance. Examples of Class II devices include powered wheelchairs, pregnancy kits, infusion pumps, air purifiers and surgical drapes.
This category of medical devices usually helps support or sustain life and is substantially important in preventing impairment to human health. It also has the potential to pose unreasonable risk of illness or injury to the intended user. Since insufficient information exists in this case, such devices need pre-market 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 the MD classifications of specific HAs, manufacturers must also keep abreast of updated Regulatory requirements, Regulatory pathways, market approval processes and so on failing 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 IVDR 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. Our professionals, with expertise in medical device master file compilation and technical file compilation, can support over a spectrum of dossier compilations.
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 following compulsory approval procedures for the US FDA Region.
- Pre-market notification 510(k)
- Pre-market approval (PMA)
- 513(g) Applications
- Premarket Approval applications
- De Novo Petition
- Establishment Registration and Device Listing
- Medical Device Gap Analysis
- Local Agent Services
Freyr aids in making the approval process easier in the European Union and is adept in tackling the multi lingual and complex regulations of different agencies.
- Technical File Preparation and Submission
- CE Marking and Approvals
- ISO QMS Certification
- EU MDR Support
- 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.