The World Health Organization (WHO)has issued a set of draft guidelines for a global model regulatory framework for medical devices including in-vitro diagnostic devices. The regulator is seeking industry comments for the same before July 12. Indian medical device companies see the move as a step in the right direction.
According to Manoj Menon, medical device consultant who was earlier with GE Healthcare said that the guidelines were anticipated for a long time and is a welcome move. The move will help improve quality of devices and solutions substantially; remove sub-standard devices and bring in transparency. However, the regulatory body should be also geared up for speedy and quality inspections through build up of appropriate tools, infrastructure and trained manpower. A step by step approach is required to manage the large pool of devices marketed.
Medical devices require the highest material and manufacturing standards. Without medical devices, routine medical procedures from bandaging a sprained ankle, to diagnosing HIV/AIDS, implanting an artificial hip or any surgical intervention would not be possible, noted WHO in its draft guidance.
The medical devices are used in many diverse settings. It could either be on a lay person at home, paramedical staff, clinicians in remote locations and highly trained medical professional in advanced medical facility. Even for opticians and dentists, medical devices are indispensable. Such health technologies are used to diagnose illness, to monitor treatments, assist disabled persons, or intervene and treat illnesses, both acute and chronic. Today there are an estimated 5,00,000 different kinds of medical devices in the world market, separated into more than 10,000 generic devices groups.
The resources people, funds, technology and facilities available in any country for regulatory control of medical devices are limited. Generally, such resources will be allocated to support overall government policy objectives and priorities but it also reflects the characteristics of the national market for medical devices. Medical devices are barometer of public health needs, burden of disease, demographic trends, economic development among others. It also indicates the industry structure on sources of supply which covers imported versus domestic manufacture.
The WHO has pointed out that regulation of medical devices does not take place in isolation and it should be coordinated with regulation of other products like medicines, vaccines, and government policy objectives.
The WHO model recommends guiding principles, harmonized definitions and the essential elements required for effective and efficient regulation. Its main elements refer to international harmonization guidance documents developed by the Global Harmonization Task Force (GHTF) and its successor, the International Medical Device Regulators Forum (IMDRF).
“The model is particularly relevant for WHO member states with no or limited regulation for medical devices in place. Yet it foresees that countries will progress from basic controls towards an expanded level as their resources allow. It will also describe circumstances in which a regulatory authority may rely upon, or recognize, the work products from trusted regulatory systems providing scientific assessments, audit and inspection reports or WHO pre-qualification,” stated the draft guidance.
The draft also indicated that there are limitations to the Global Model Regulatory Framework for Medical Devices including IVDs. Therefore the model provides a general approach and cannot provide country -specific guidance on implementation. While it does not offer detailed guidance on regulatory topics, it provides references to relevant documents. It does not detail responsibilities of manufacturers, distributors and healthcare professionals, who have roles to assure quality, safety and performance of medical devices.