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Legal and Regulatory Regime: Medical Technology
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Legal and Regulatory Regime: Medical Technology

As technology is changing rapidly, it opens the new regime within the domain of health care. Advancement in medical technology such as personal medical devices, open-source hardware and mobile phone apps are creating opportunities to improvise the medical industry.  In order to regulate the new challenges, it is necessary to balance the need for regulation along with flexibility and efficiency in the use of technology.  With the comparison of new health technology the designs, standards and regulations evolve slowly and therefore some difficulties can be faced while applying the standards to these regulations. For instance, the current regulations may not be suitable for upcoming medical technology. The standards may not be that flexible while evaluating the usability of other upcoming medical technology. Regulation for medical technology in India is ambiguous, complex and opaque. There are certain issues pertaining to regulation on medical technology. The medical technology industry has no separate legal status. Earlier, it was regulated by the Drug Controller General of India (DCGI) under the Central Drugs Standard Control Organization (CDSCO). It was found that regulation covers few medical devices under the ambit of Drugs and Cosmetic Act 1940 with subsequent amendments. But it was necessary to distinguish medical devices from pharmaceutical products.

Absence of Specific regulation and coverage under the Drugs and Cosmetic Act has resulted in a lack of transparency and clarity about the regulations. These industry face problems pertaining to multiple levels of government authority involved in enforcing the guidelines and inconsistent interpretation of the regulatory guidelines by authorities. It resulted in a prolonged and cumbersome regulatory pathway for new and existing products.

India’s Ministry of Health and Family Welfare released the Medical Device Rules, 2017 which came into force from 2018. It contains the regulations applicable to medical devices and in-vitro diagnostic medical devices. The regulation states that all medical devices will be placed into four classes based on the use of device and the risk of using the device. The government has been selective in the regulation of medical devices as until the device has been notified under Drug Cosmetic Act and Medical Device Rules it will not be regulated. The government has overhauled the regulatory framework and has brought it at par with international norms with the concept of ‘risk-based regulation’.

Under the applicable regulatory framework of medical devices, the function of manufacture, import, sale and distribution of medical devices require licenses or permissions from the Central Drug Licensing Authority and State Drug Licensing Authority.

Manufacturing a medical device requires a separate license for each medical device which is notified. Also, for importing the medical device in India it is necessary to satisfy a few additional legal requirements. The import of all medical devices is governed under the Export and Import Policy.

To understand how the regulatory framework around medical technology is evolving, the comparison of Indian regime with other developed countries can be followed.

In recent years, due to the rapid advancement in scientific discovery and technology developments in the UK, it helps the patient to manage and track their health conditions on the go. Also, the growing number of health technologies available can be adapted to support personal care in terms of electronic devices.

For instance, three-dimensional printers are devices that create three-dimensional objects based on electronic data where printers have opened up the possibility to produce custom made medical devices as and when needed. These types of advances continue to provide solutions to health care problems that seem to be impossible to solve and they generate their own considerations about the procedure to see how these technologies fit into existing regulatory framework.

But the medical technologies do not always fit into the specified standards because they take a step ahead from what it is currently accepted as practised. There are possibilities that innovation may be hurt by the current regulatory system. However, sometimes the existing standards may not be applied or in use and after development in modern technology they are unable to apply. The steps followed for the development and testing the medical device was created with a traditional manufacturing process, at a certain point, the design would be freeze and considered as complete. Repeated change in standards and its requirements may be cumbersome for evolving medical technology.

Even though there has been progressing towards using explanatory method to investigate the context of use, standards are lacking in their treatment. The experience of user relates a context that the important factor in determining how people will accept the technology and interact with it.

There is an opportunity for standards to support consideration of a broader range of context.

Also, there are many issues in the certification of health-related apps. Regulation is required and although guidance on technologies may exist, it may not be clear whether such standards can be covered under regulations.

For medical technology, the standards and regulations are needed to ensure safety for protecting the public and guarantee that products are fit for purpose, the current approach towards regulation is not only feasible but difficult to enforce.

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