Medical Devices Rules 2017

Medical Devices Rules 2017

Subject – Governance

Context – Industry seeks role in framing regulations for medical devices

Concept –

• The proposed drugs, cosmetics and medical devices Bill should align with the Medical Devices Rules (MDR), 2017, experts have said.
• Medical devices were governed by the MDR 2017, which were meticulously developed by the Central Drugs Standard Control Organisation (CDSCO) after extensive consultations with stakeholders.
• These rules also follow the World Health Organisation Regulatory Framework for Medical Devices (including in vitro diagnostics) and adhere to the step-wise approach to regulating medical devices based on guidance documents developed by the Global Harmonization Task Force (GHTF) and the International Medical Device Regulators Forum (IMDRF).
• The harmonised regulations also enable Indian manufacturers to get greater acceptability of their products in global markets, furthering the Make in India objective of the Government and keeping India aligned to global supply chains.

Medical Devices Rules, 2017

• The industry manufacturing medical devices in India was governed under the stringent laws of The Drugs and Cosmetics Rules, 1945, up until recently, when the government decided to heed to the industry’s plea for a separate regulation.
  • The defect in the prior regulation was that the medical devices listed in the Schedule C of The Drugs and Cosmetics Rules, 1945, was governed being considered same as the drug manufactures in India.
  • This defect was considered as a major turnoff by the medical device manufacturers who believed strongly that medical devices be considered separate from the drugs.
• The Medical Devices Rules aim to ease the rules regarding medical devices, including but not limited to obtaining licenses, clinical trials etc.
• The Medical Devices Rules notified by the Ministry of Health and Family Welfare has been formulated to be in conformity with the Global Harmonisation Task Force framework and the international practices.
• The Medical Devices Rules 2017 has been formulated with an aim to simplify the rules regarding medical devices in India. In light of the same aim, the rules have provided for self-assessment/ self-certification of compliance for manufacturers belonging to Class A of categories prescribed under Medical Devices Rules 2017.

Medical Devices (Amendment) Rules, 2020

• The Medical Devices (Amendment) Rules, 2020, are applicable to devices “intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals” and
• require online registration of these devices “with the Central Licensing Authority through an identified online portal established by the Central Drugs Standard Control Organisation for this purpose”.
• Every medical device, either manufactured in India or imported, will have to have quality assurance before they can be sold anywhere in the country.
• Manufacturer shall mention the registration number on the label of the medical device.

What are the items covered under the Medical Device Rules?

• Items covered includes: hypodermic syringes and needles, cardiac stents, perfusion sets, catheters, orthopaedic implants, bone cements, lenses, sutures, internal prosthetic replacements etc.and will have to comply starting April.

What are the penal provisions under Indian law?

• Manufacture or sale of substandard items is punishable with imprisonment of at least 10 years, which may extend to imprisonment for life.
• There is also a provision for fine that will “not be less than Rs 10 lakh rupees or three times value of the confiscated items”.