New Medical Devices rules would usher in rejuvenated regulated atmosphere


Suresh Kumar, Senior VP, Product Services TÜV SÜD South Asia, in an interaction with Viveka Roychowdhury, opines that the medical devices industry will receive an exponential boost once regulations are in place

TÜV SÜD was the first independent certification firm in India to receive an accreditation from National Accreditation Board for Certifying Bodies (NABCB) to grant certifications for ISO 13485 & ICMED Schemes. What is the certification process? Does it involve site audits, etc.? What are the parameters required for such certifications? How many such certifications have been granted so far? And what are the costs involved for manufacturers to obtain, maintain and renew such certifications?

Medical device manufacturers can apply to TÜV SÜD for ISO 13485 and ICMED schemes to obtain certifications that indicate their products comply with regulations for domestic use and exports. The initial certification process entails onsite documentation and compliance audits. Once the organisation meets the quality requirements, it is awarded a certification for three years. The validity of the certification is subject to the successful completion of announced surveillance audits in the following two years. In ICMED schemes, surveillance audits are conducted spontaneously. Since this is a comparatively new accreditation, we have a considerable number of certifications that are in the pipeline for final closure. The costs for obtaining these certifications are commensurate with global standards and consists of elements such as annual certificate license and certification body review services.

TÜV SÜD is also part of the Medical Device Single Audit Programme (MDSAP), which is aimed to help manufacturers get their devices into multiple global markets through a single audit. MDSAP was slated for official implementation from January 2017. What is the update on this? What is the response?

The pilot phase of the MDSAP programme concluded on December 31, 2016 and became operational on January 1, 2017. Medical devices manufacturers face two significant challenges — increased product development costs and time to market. They need to apply for testing and certification with different certification bodies to gain access to individual export markets. MDSAP allows authorised auditing organisations to conduct a single audit of a manufacturer’s quality management systems that will satisfy some requirements of the regulatory authorities of each participating country. It saves time and money as business can gain access to multiple markets with a single audit programme. This single audit programme helps business save money, minimises administrative overheads and reduces the number of annual audits that help businesses enter markets faster.

TÜV SÜD works closely with clients that are a part of the MDSAP programme. It can support any medical device manufacturer regardless of their current certification body. Being one of the largest notified bodies, TÜV SÜD provides expert on-site technical file review gives access to information that helps the manufacturer understand any non-compliance issues.

Consumer perception is that low cost is linked to low quality. How can indigenous manufacturers of life saving products like medicines and medical devices counter this perception?

Contrary to popular perception, the cost of any medical device is not a function of its quality. Traditionally, imported devices have been costly because of the multiple layers of taxation. Stringent quality control and certification measures at a domestic level can help drive down costs and increase quality at the same time.

Indigenous manufacturers can contribute by self–regulating the quality of products manufactured by them. This in addition to a policy and regulatory collaboration can help counter the perception of cost being a function of quality for medical devices.

The ISO 13485 and ICMED certifications awarded by TÜV SÜD specifies requirements for a quality management system that can benefit an organisation right from design to practical usage of medical devices and related services. By getting their facilities certified by a reputed notified body like TÜV SÜD, organisations have the potential to contribute toward changing the perception of consumers and ensure quality products.

What is your take on the recently notified Medical Devices Rules 2017, the Indian government’s first move to regulate this sector? Are these Rules in harmony with global regulations? What are the points of deviation and these justified?

The new rules notified under Medical Devices Rules 2017 seek to remove regulatory bottlenecks to Make in India, facilitate ease of doing business and ensure availability of better medical devices. They have been framed in conformity with Global Harmonisation Task Force (GHTF) framework to adapt to best international practices.

The new Medical Device rules would usher in a rejuvenated regulated atmosphere. Yes, the new rules are in sync with International Medical Device Regulators Forum (IMDRF) and will benefit the industry on a large scale as the organisations will now compete at a global level.

In Budget 2017, the government proposed to move the medical devices segment out of the pharmaceutical sector to attract foreign investments. Do you see any positive movement as yet on this front?

The announcement made in this fiscal’s budget has directionally propelled the Indian medical industry to invest in indigenous manufacturing. Currently, 75 per cent of the total demand for medical devices is met with imports and nearly 30 per cent of it is imported from the US alone. We are importing from a country that is one of the global champions in medical devices innovation and due to which there is a disparity between the design of certain technologies and the conditions of healthcare infrastructure in India. Also, regulatory standards of medical devices are not upgraded periodically causing ambiguity in standardisation of medical devices. Globally, the medical devices industry is separate from pharma sector and governed by an independent set of legislations and regulatory framework.

The Indian pharma industry has already earned worldwide respect and it is time for India’s medical devices industry to follow the suit. The announcement has given a tremendous boost to indigenous manufacturing to achieve global manufacturing competitiveness and make devices more affordable. Post the announcement, the government has proposed to set up a separate ministry for Indian medical devices. It is encouraging to see the government’s intention to transform the industry with the right amount of policy push and similar changes will take its time to streamline the entire infrastructure.

While some policy measures seem to favour the industry, others are clearly with the end user in mind, like the recent crackdown on prices of  heart stents. NPPA is sure to follow with more price constraints on other high-end medical device categories like orthopaedic implants. Will these moves discourage further investment of both global and local players into the medical devices sector in India?

We support the government’s decision because the aim of this policy measure resonates with our vision, to safeguard patients’ interest and their safety. We believe, it has the potential to encourage global and local players as the decision to cap prices on medical devices will rid the industry of pricing ambiguity that will boost domestic manufacturing and uphold trust and safety in minds of the end – consumers.

Domestic manufacturers may still be able to make medical devices at prices lower than global competitors but is this a sustainable business model? With increasing price constraints, and decreasing margins, will regulatory requirements like accreditation, certification, etc. be an additional burden on local manufacturers?

The regulatory framework for the Indian medical devices industry has been rudimentary with a duty structure that is not highly favourable for manufacturers. However, there is an opportunity for businesses to understand the dynamics of the market and launch devices and device-based therapy models that are a breakthrough in innovation. The Make in India initiative has accelerated foreign investment and encouraged global organisations to set up manufacturing in India. This is an opportunity for such organisations to partner with domestic companies for an efficient growth strategy. Partnering with certifying bodies such as TÜV SÜD that conduct quality testing audits of manufacturing units as well as the devices will instill an increased level of trust among other manufacturing companies vying for market entry. This accreditation acts like an enabler for domestic manufacturers and helps them embrace global standards of safety and quality.

Our dependence on imports has shadowed the innovative capabilities of domestic manufacturers. To empower them, tax incentives could be offered to promote manufacturing. As local manufacturing becomes the norm, it is likely that an overall tone of affordability would be set in the industry. We are witnessing a growing interest among entrepreneurs to revolutionise the Indian medical device industry by developing products that are low-priced and high-quality, and such initiatives should get an appropriate policy push.

Industry reports suggest that the Indian medical devices market is at $3.8 billion in 2014 and is expected to grow to $8.6 billion by 2020 but India still imports 70 per cent of medical devices. What more should the government, both at the centre and state level, do to rectify this situation to promote and incentivise Make in India?

The government’s recent effort to move medical devices out of the pharma sector is a welcome move for the domestic manufacturers. We are certain that industry will receive an exponential boost once the regulations are in place. To ensure a sustained growth of the Indian medical devices market, the government should further incentivise the ‘Make in India’ campaign so that more domestic companies can be encouraged to manufacture devices in compliance with global standards.

How do medical devices exporters juggle the varying regulatory requirements of different countries?

At present, they may approach each market separately. With MDSAP by TÜV SÜD, this will help and ease their regulatory burden. MDSAP is a single audit programme that satisfies some requirements of the regulatory authorities of each participating country. Manufacturers across the globe can participate in MDSAP. The five participating regulators are in these countries — the US, Canada, Brazil, Australia and Japan; and the medical product must fall under the scope of at least one participating regulatory authority and be subject to their quality management system requirements.

For maximum accountability, TÜV SÜD assigns one lead auditor who is responsible for tracking certifications, managing change notices, and delivering a rapid response to the queries. An inherent part of our services is to keep our customers and partners updated with the dynamic landscape. We have a proprietary E-ssentials newsletter that helps manufacturers stay updated with the latest developments of the MDSAP programme.

At an operational level, have local medical devices manufacturing facilities met the scrutiny of global regulators? Are local medical device companies training their staff to handle facility inspections and audits?

Some local medical devices manufacturing facilities have been successful in meeting the scrutiny of global regulators, but this is not the case across the board. Staff training for handing facility inspections and audits are largely at the discretion of the company and there is immense opportunity to improve. At TÜV SÜD, we also provide separate training sessions with an aim to help the manufacturers understand safety and quality guidelines as well as the related certification technicalities. These training modules help manufacturers improve the ecosystem of quality awareness among their employees, thereby effecting world class manufacturing of medical devices.