Consultancy on Registration of Medical devices

Nowadays, it is almost impossible to find a country where medical products circulated in its market are unregulated. Though drug regulatory sector usually start before that of medical device, it doesn’t always take longer to adapt the approach and begin the regulation of medical devices for countries who already have medicines regulatory framework in place. Most countries are rapidly advancing their national medical device regulatory system by establishing an independent institution who is legally mandated for regulatory oversight of medical devices to be marketed in that country. In countries where there is no such established separate institution (agency), a department or a division under the national health ministry may be given such authorities to carry out the regulatory oversight of medical products including medical devices.
One of the major premarket regulatory control activities performed by regulators is Marketing Authorization and registration. It is a permission granted by a mandated National Regulatory Authority (NRA) to a medical device for its marketability in that country. The decision for this authorization depends on a series of premarket assessment outputs including- product dossier review, onsite audit/inspection of the manufacturing facility and product lab test (as applicable).

Product dossier assessment is a primary activity that most regulators start to do before other regulatory activities as part of their premarket control. A product dossier is formed from a compilation of different administrative and technical documents as required by an NRA. Though some countries have adapted the marketing authorization submission table of contents (MA ToCs) developed by the International Medical Device Regulators Forum (IMDRF) for both IVDs and Non-IVDs, most countries are still using the previous Summary Technical Documentation (STED) where the format, presentation and some requirements differ from that of the MA ToCs requirements. In most cases, countries also have their own requirements designed to address local needs specific to that country. This unharmonized requirements and submission formats remain to become a big challenge to manufacturers and product owners making it difficult to market their devices worldwide.
To help manufacturers overcome challenges of this complex and rapidly changing regulatory landscape, we are working tirelessly in Ethiopia (where our company is physically located) to register their devices with Ethiopian Food and Drug Authority (EFDA) as well as in India, China, Turkey, Australia, Korea and some selected African Countries (the list of which is published very soon) through our partners in these countries.

The range of consultancy services we provide in the scope of ‘Device Registration’

• Selection of the appropriate regulatory pathway for devices in the registration project contract.
• Advice in the development of registration plan for manufacturers who want to divide their devices into different registration batches to register them in different years (under different project contract) due to different reasons.
• Advice on details of an NRA’s regulatory requirements for granting marketing authorization and registering the devices (this may include- product dossier review, onsite inspection or desk-review of the manufacturer’s Quality management system, quality control lab test and their services’ associated fees that may be required).
• Identification of mandatory and optional documents required by a National Regulatory Authority for each device.
• Advice on how manufacturers should compile and present the identified product dossiers for each device.
• In depth review of compiled product dossiers for each device before submitting for regulatory review.
• Submission of the dossiers to the NRA and be local representative of foreign manufacturers to continuously follow-up the issues of that manufacturer regarding the registration of its products and beyond.