Are you aware of the regulatory changes in the medical device industry?

Never before have we seen the policy environment in medical devices in India evolve at a pace this fast! Covid times brought a lot of focus on the medical devices sector and we now see significant Government efforts to support and streamline regulation in this sector. We can expect to see more changes in the coming months.

While changes might seem uncomfortable, these changes will help shape the sector in India, hopefully propel it to a prominent position globally.

Lets look at some of the changes in the recent past.

The National Medical Devices Policy 2023 ?

On 26th April 2023, the Cabinet approved the Policy for the Medical Devices Sector, the National Medical Devices Policy, 2023. A clearly articulated vision shared the goal of driving accelerated growth with a patient-centric approach and help India emerge as the global leader in the manufacturing and innovation of medical devices by achieving 10-12% share in the expanding global market over the next 25 years.?The policy aims to help the Medical Devices Sector grow from present $11 Bn to $50 Bn by 2030.

This is a landmark shift in an industry which has an import dependence of ~80%, and a clear message to drive Make in India, for India and the World. ??

A new Act to improve focus on Medical Devices

Medical Devices are currently regulated under the Drugs and Cosmetics Act 1940 and as the industry grows, senior Industry Leaders have raised the need for an Act that centres around medical devices. It is expected that the union government will table the Drugs, Medical Devices and Cosmetics Bill, 2023 in the ongoing monsoon session of parliament. This will replace the 80-year-old Drugs and Cosmetics Act, 1940 and is expected to improve understanding and focus on the sector.

Regulating all Medical Devices, Risk Classification of devices

As per the DCGI, India is on course to introduce regulations governing all the medical devices in the country on October 1, 2023.

Currently Class A and B medical devices are regulated and the direction is to include Class C and D devices under regulations as well.

To refresh our memories, the Central Drugs Standard Control Organization (CDSCO) had classified devices into 4 classes: Class A,B,C,D in ascending order of risk- low risk, low-moderate risk, moderate-high risk, and high risk respectively for the purpose of regulation.

PLI

The Production Linked Incentive Scheme (PLI) is a much spoken about initiative. The PLI and Promotion of Medical Devices Parks Scheme are a testimony to the intention to provide a strong impetus to increase MedTech manufacturing in India. The direction to reduce imports and encourage local manufacturing is clear. In 2022, 371 MedTech products were allowed for imports and the number reduced to 364 in 2023 as per last reports.

Implementing local medical device manufacturing is complex and the PLI is just one enabler for local manufacturing. What’s important is to recognize it as the first of many important enablers that the government will undoubtedly bring, to get India at par with preferred medical device manufacturing locations like Ireland.

For me, this is an area I watch with deep interest.

Digital Personal Data Protection Act 2023

The Bill will apply to the processing of digital personal data within India where such data is collected online or offline and is digitized.?It will also apply to data processing outside India, if it is for offering goods or services in India.

Implications: While we still await detailed interpretation, this Act will be relevant for Hospitals, device manufacturers, doctors and surgeons who collect and store patient or surgeon data.

The E-Waste (Management) Rules, 2022, effective 1st April 2023

These rules effective from 1st?April, 2023, launched a new Extended Producer Responsibility (EPR) regime for e-waste recycling. The new rules are applicable to every manufacturer, producer, refurbisher, dismantler and recycler. They are required to mandatorily register on the CPCB Portal. Producers of notified Electrical and Electronic Equipment (EEE), have been given annual E-Waste Recycling targets based on the generation from the previously sold EEE or based on sales of EEE as the case may be.?

Implication: Additional cost to manufacturers and capability to develop and handle protocols.

The Battery Waste Management Rules, 2022

The new rules apply to all types of batteries regardless of their chemistry, shape, volume, weight, material composition, and use. The main highlight of the Battery Waste Management Rules 2022 is extended producer responsibility, which was previously limited to e-waste and plastic waste management.

Implication: Impact on equipment manufacturers for products with batteries like Power Tools, surgical robots etc.

Plastic Waste Management Rules, 2022

All institutional generators of plastic waste shall segregate and store the waste generated by them per the Solid Waste Management Rules, and hand over segregated wastes to authorized waste processing or disposal facilities or deposition centres, either on their own or through the authorized waste collection agency.

Implication: This needs clarity- because plastic packaging can be contaminated with biological fluids and is disposed as biological waste.

Increasing regulation in medical devices typically indicates a growing level of maturity in the industry. It also reflects the extensive work done by industry leaders over years to collaborate with the government to grow the industry. As time passes some of the rules and Acts might be modified, and interpretations better defined. It is important to be aware of the changes happening so we can empathise better, to the resulting changes in our organizations.

How do you think these regulatory changes will impact various medical device and diagnostics manufacturers?

Which other regulatory changes do you think are important and we need to watch?

#medicaldevices #futureready #healthcare #Indiastrategy #thoughtleadership