Role of Regulations in public health

Medical devices have a fundamental role in saving lives by providing innovative healthcare solutions for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease.

Regulation is primarily concerned with enabling patient to access high quality, safe and effective medical devices, and avoiding access to products that are unsafe. When appropriately implemented, regulation ensures public health benefit and the safety of patients, health care workers and the community. Regulatory systems for medical devices are less developed than those for other health products such as medicines or vaccines. According to desk survey performed in 2015-2016, 58% of WHO member states have a regulation for medical devices in place, no matter how limited.

A secondary benefit of introducing regulatory systems is that domestic manufacturers will not only be encouraged to develop and market alternatives to imported devices but will also have an opportunity to grow their business through exporting such products. This is only possible when medical device regulations have been harmonized with regulations already established in major overseas markets.

A less obvious benefit of introducing a regulatory system in the long-term is that the databases developed to track medical devices and to monitor their post-marketing performance may be used to improve national and local medical device procurement procedures. However, while these benefits are significant and desirable in all countries, the manner and speed with which they are achieved depend on factors such as:

– Political priorities;

– Agreement of a realistic, long-term implementation plan, actively supported and led by policy-makers;

– Availability and development of specialist expertise in medical devices; and

– Provision of sufficient funds

Some countries may wish to adopt a “single-market” approach to medical devices under one regulatory regime and with mutual recognized regulatory controls across the region, similar to the European Union. Existing global harmonizing initiatives include the International Medical Device Regulators Forum (IMDRF), Asian Harmonization Working Party (AHWP), and the Pan-American Network of Regulators.

In Summary, Regulations in Medical devices Improves the quality, safety and reliability of medical devices, Strengthens transparency and information for patients and Enhances vigilance and market surveillance.