India Blog Posts

India Officially Proposes Expansion of Regulatory Oversight to More Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • Indian regulator CDSCO to formalize proposals to expand registration requirements to more types of medical devices.
  • Affected manufacturers will have one year following publication of new requirements in the Gazette of India to comply.
  • Types of devices to fall under CDSCO oversight include implantable devices, CT and MRI equipment and dialysis systems.
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India’s CDSCO Plans to Regulate Additional Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • Indian regulators intend to expand oversight to additional types of medical devices.
  • The Indian CDSCO has identified ultrasound and related imaging equipment as additions to its List of Notified Medical Devices.
  • CDSCO has not provided any timeframes for when these products will become regulated devices.
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Indian Regulators Issue FAQ on Medical Device Rules

EMERGO SUMMARY OF KEY POINTS:

  • A new FAQ from the Indian CDSCO addresses several questions regarding compliance with the new Medical Device Rules 2017.
  • Issues covered in the FAQ include status of medical device registration applications still under review at CDSCO, notified medical device listing changes and standards compliance.
  • India’s Medical Device Rules 2017 went into effect in January 2018.
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India: Draft Essential Principles for Medical Device Safety and Performance Out for Comment

EMERGO SUMMARY OF KEY POINTS:

  • The Indian CDSCO has published draft Essential Principles for medical device and IVD safety and performance.
  • Indian regulators are seeking industry comment through August 2017 on the proposed Essential Principles.
  • The draft Essential Principles are part of India’s new Medical Device Rules, 2017 slated for early 2018 implementation.
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India’s CDSCO Issues New List of Medical Devices and their Classifications

EMERGO SUMMARY OF KEY POINTS:

  • Draft CDSCO list clarifies medical device and IVD types notified for Indian market registration
  • More types of IVD products would fall under Medical Device Rules 2017 notification requirements
  • Formal inclusion of devices requiring registration but not previously added to notification list
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India Authorized Agent Role Changes under New Medical Device Rules

EMERGO SUMMARY OF KEY POINTS:

  • India’s new Medical Device Rules include expanded responsibilities for India Authorized Agent in-country representatives.
  • India Authorized Agents will have added importation responsibilities, and CDSCO will allow multiple Agents for imported devices.
  • Agent role changes will go into effect assuming that Indian regulators are able to meet their own early 2018 implementation timeframe.
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India Update: New Medical Device Rules Will Apply Only to Products Currently Regulated by CDSCO

EMERGO SUMMARY OF KEY POINTS:

  • New Indian Medical Device Rules will cover only those device types that already fall under CDSCO oversight.
  • Existing Indian registrations will remain valid until 2020, according to informal discussions with the CDSCO.
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First Take: New Indian Medical Device Regulations

EMERGO SUMMARY OF KEY POINTS:

  • India’s new Medical Device Rules 2017 will introduce more formalized registration requirements compared to the country’s current system.
  • The new rules include risk-based classification, unique identification requirements and manufacturing quality audits by Notified Bodies.
  • Companies with devices currently registered for sale in India can anticipate a transition period in order to comply with the new rules following their 2018 implementation.
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Indian Regulators Publish New Medical Device Rules

EMERGO SUMMARY OF KEY POINTS:

  • The Indian government has published new medical device and IVD regulations to replace the country’s Drugs and Cosmetics Act.
  • The new rules will go into effect January 1, 2018.
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Indian Regulators Open Comment Period for Proposed Medical Device Rules

EMERGO SUMMARY OF KEY POINTS:

  • Draft medical device regulations have been published in India’s Official Gazette.
  • Industry has 30 days (until mid-November 2016) to comment on proposed regulatory changes.
  • Draft regulations would create separate registration and oversight systems for drugs and medical devices.
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