India’s new Medical Devices Rules, 2017

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The Ministry of Health and Family Welfare on 31st January, 2017 notified the new Medical Devices Rules 2017 which can have major implications on the cost and accessibility of healthcare in India. This is a much awaited move to regulate and incentivize this nascent but fast growing industry where nearly 70% of domestic demand is met by imports[i]. The recently released National Health Policy 2017 is also looking to encourage the production of medical devices.

The rules seem to have improved on the Draft Medical Device Rules released in October 2016 considering they have incorporated several stakeholder demands including those of bodies such as the Medical Technology Association of India (MTAI). The goal of the new 2017 Rules is two-fold: To harmonize medical device manufacturing regulation with global standards and to increase affordability of healthcare services for the poor.

To achieve these goals, several requirements have been addressed:

  1. The most important change is the separation of medical devices from pharmaceuticals and drugs under The Drugs and Cosmetics Act, 1940 to constitute separate focused rules for medical devices completely. Medical devices are currently treated as drugs under the Act as a result of which only 22 of over 10,000 types of medical devices in India are regulated[ii].
  2. Medical devices have been divided into 4 categories according to risk type so that lower risk devices are subject to lower government regulation and scrutiny. Devices are divided into Class A (low risk), B (low moderate risk), C (moderate high risk) and D (high risk). Class A devices are eligible for obtaining a license prior to the audit of the manufacturing site. The producer is then required to have the audit conducted within 120 days of granting of the license while for Class B devices, the audit is required to be conducted prior to license granting 90 days from the date of application.
  3. Producers of the Class A & B devices are only required to apply to the State Licensing Authority whereas the rules are more stringent for Class C&D devices, requiring producers to apply to the Central Licensing Authority[iii]. Another unique measure is the outsourcing of auditing to third party (government notified) bodies. All of these measures could help promote ease of doing business while at the same time ensure safety standards of high risk devices.
  4. Further to promote the ease of doing business, periodic renewal of licenses has been abolished; a license once granted will remain valid indefinitely unless cancelled or surrendered. A digital interface has been provided for several procedures.
  5. The clinical trial requirements have also been relaxed. The medical device industry earlier had to unnecessarily adhere to the highly stringent 4-phase process applicable to the pharmaceutical industry. The new rules have reduced the clinical trial process to two phases[iv]. The validity term for test licenses for clinical trials has also been extended from the current 1 year to 3 years[v].
  6. To follow international standards, the medical device rules have been drafted in accordance with the International Medical Device Regulators Forum (originally the Global Harmonisation Task Force (GHTF)) framework.

However, the medical device industry still has some concerns regarding lack of regulation regarding the use of import of refurbished parts as well as the limit placed on the shelf life of medical devices to 60 months (5 years) from the date of manufacture. With respect to the latter, the industry feels 5 years is too low given that devices unlike drugs are more stable and also fears that this condition will increase the cost of healthcare[vi].

Overall the notification is an extremely positive move for this highly unregulated sector. The new rules could give a much-needed impetus to the frugal medical devices market and med-tech sectors, both of which are emerging start-up sectors. The government has given companies time till January, 2018 to become compliant with the new rules. At the same time the government must continue to engage with various stakeholders to address the above concerns and any unanticipated issues before the implementation next year.


[iii] MoHFW Notification: Medical Devices Rules 2017

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