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25 August 2026

Medical device regulation amendments

The topic involves specific amendments to the Medical Devices Rules, 2017, which directly relates to government policy interventions in the health sector and industrial regulatory reforms.

1 min read 2 questions 2 prelims

Notes

  • The Union Health Ministry has proposed amendments to the Medical Devices Rules, 2017, to enhance ease of doing business.
  • Rule 44 amendment: Manufacturers outsourcing sterilisation to a licensed facility no longer require a separate loan licence for that activity.
  • Traceability requirement: Manufacturers must include the licence number of the outsourced sterilisation facility on the product label.
  • A six-month transition period is provided for companies to update labels and packaging.
  • Rule 63 amendment: The European Union (EU) has been added to the list of stringent regulatory jurisdictions whose approvals allow for the waiver of clinical investigation requirements in India.
  • Existing jurisdictions for clinical investigation waivers include the US, UK, Australia, Canada, and Japan.
  • The amendments aim to reduce administrative burden, compliance costs, and regulatory timelines while ensuring patient access to new medical technologies.

Questions

  1. Discuss how the proposed amendments to the Medical Devices Rules, 2017, aim to balance regulatory oversight with the objective of promoting ease of doing business in the healthcare sector. 150 words
    Attempt this — 150 words in 8 min
    0 / 150 words 8:00
  2. The integration of international regulatory standards is crucial for the growth of the medical device industry in India. Elaborate on how recognising global regulatory jurisdictions for clinical investigation waivers impacts the domestic healthcare ecosystem and patient access to technology. 250 words
    Attempt this — 250 words in 11 min
    0 / 250 words 11:00

Prelims

  1. Under the proposed amendments to the Medical Devices Rules, 2017, which of the following is true regarding outsourced sterilisation?

  2. Which of the following regions was recently added to the list of jurisdictions recognised for waiving clinical investigation requirements for medical devices in India?

Syllabus

Topics

Sources

250words.in · https://250words.in/daily/2026-08-25/medical-device-regulation-amendments