Medical Devices

Introduction

The medical device industry has been identified as a sun-rise industry by the Government of India. This recognition indicates that it has special attention of the government because of its future growth potential. Over the years, it has consistently recorded faster growth than India’s much respected pharmaceutical industry. India’s medical device market, unlike the market for medicine, is still import dependent. The government is taking steps to reduce India’s import dependency for medical devices.

Most important laws

  • The Medical Devices Rules, 2017 regulates the quality of notified medical devices that are imported, manufactured and sold in India in accordance with its risk classification.
  • The Drugs (Prices Control) Order, 2013 regulates the price of notified medical devices sold in India.
  • The Competition Act, 2002 regulates anti-competitive behaviour amongst manufacturers, supply chain and other stake holders.
  • The Consumer Protection Act, 1986 / the Consumer Protection Act, 2019 regulates unfair trade practices and restrictive trade practices, and imposes product liability for manufacturing defects in product that cause harm
  • The Patents Act, 1970 provides for patent over innovative medical devices, but does not allow ever-greening.
  • Trade Marks Act, 1999 provides trade mark protection, in addition to common law protection for passing-off that exists India.
  • The Bureau of Indian Standards Act, 2016 prescribes standards for both regulated and unregulated medical devices
  • The Legal Metrology (Packaged Commodity) Rules, 2011 prescribe numerous labelling requirements, including declaration of customer care number, on the package

Key things to remember

  • Only those medical devices that are notified by central government are regulated. However, manufacturers and importers should be aware of voluntary standards set by Bureau of Indian Standards for unregulated medical devices.
  • The prices of notified medical devices are regulated in India. The ceiling price for coronary stents and knee implant systems have been fixed by the government.
  • It is unethical in India to  pay for personal expenses of a Doctor’s hotel accommodation and travel cost incurred during a training event.
  • All medical devices manufactured or imported into India must carry all prescribed declarations on its label. For imported medical devices, it is common to repeat one or more declarations on the same label if the declarations do not appear at the prescribed areas of the label.
  • The Government is planning to formulate rules for putting in place a data registry for tracking implants sold, used on patients and Doctors / Hospitals involved. 

Important sub-segments and related industries

  • Med Tech
  • Implants
  • Wearables
  • Equipment
  • Disposables
  • Materiovigilance

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