Quality Assurance In Healthcare: Understanding Standards & Certifications For Medical Device Procurement In India

In recent years, we have witnessed the healthcare segment evolve significantly and achieve rapid growth, from being valued at USD 280 billion in 2020 to reaching a whopping USD 372 billion in 2023. In the healthcare segment, which is constantly evolving thanks to the integration of cutting-edge technology, ensuring the safety and efficacy of medical devices is paramount.

As an emerging market for medical technology, India is increasingly emphasising the need for stringent quality assurance measures when it comes to procurement of medical devices. To put things in perspective, according to the Union Health Minister, the Indian medical devices sector is likely to reach USD 50 billion from the current USD 11 billion. Quality assurance not only safeguards patients but also enhances the overall efficiency and reliability of healthcare services.

To navigate the complex landscape of medical device procurement, it’s crucial to understand the various standards and certifications that govern this process. These standards, set by regulatory bodies and international organisations, serve as benchmarks for quality, performance, and safety. Compliance with these standards not only ensures the reliability of medical devices but also helps healthcare providers and patients be confident in the care they provide/receive.

In this article, we will explore the intricacies of quality assurance in healthcare and the standards and certifications that play a pivotal role in medical device procurement in India.

Government initiatives and quality assurance

Government initiatives such as Ayushman Bharat represent steps in the right direction, aiming to extend financial protection and healthcare access to millions of Indians. However, demands of consistent funding and implementation, coupled with rigorous quality control measures, are imperative to ensure their success. Quality assurance in healthcare must be an integral part of our healthcare strategy, ensuring that patients receive safe and effective treatment.

Investment in medical education and training

To ensure that healthcare professionals can efficiently provide the best possible care to their patients, it’s essential for them to receive proper training and mentorship. Investment in medical education and continuous training will enable them to acquire the required skill sets to offer the best care. Apart from this, stringent quality control mechanisms should be in place to guarantee the reliability of medical devices and the safety of patients.

Technology and healthcare access: A fine balance

Although technology undeniably has a pivotal role to play in improving healthcare, it should not overshadow the pressing need for affordable, quality healthcare services for all Indians. India's healthcare system must focus on strengthening its foundations, expanding access, and ensuring that healthcare remains a basic human right. Quality and timely healthcare must be accessible to all, irrespective of their economic status, rather than a privilege for the fortunate few.

Medical device regulation

The Medical Device Regulation, which came into effect in 2021, establishes new criteria for winning the CE mark required to put a medical device on the market in Europe. The CE mark signifies products sold that have been assessed to meet high safety, health, and environmental protection requirements. In addition to covering new devices, products already on the market must be re-assessed according to stricter criteria to keep their CE marks.

The role of the CDSCO

The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory body for cosmetics, pharmaceuticals, and medical devices. CDSCO is constantly striving to bring transparency, accountability, and uniformity in its services to ensure the safety, efficacy, and quality of medical products manufactured, imported, and distributed in the country.

Ensuring quality assurance in healthcare, especially in medical devices, is a multifaceted endeavour that requires collaboration between the government, healthcare providers, regulatory bodies, and the industry. Through combined efforts from the government and private organisations, India can bolster its healthcare system and improve healthcare outcomes for its citizens.

The author is Director, HRS Navigation

Arpit Paliwal

Guest Author