Gunjan Verma- India

“As anticipated the CDSCO responded to industry’s request to postpone the registration deadline for ultrasound equipment consistent with treatment of other newly notified devices.”
Gunjan Verma
Asia Actual India 

Come grow with us in the US in Thailand in China in Korea in the Philippines in Taiwan in Hong Kong

Important Documents and Links

INDIA SETS REGISTRATION DEADLINE FOR ULTRASOUND EQUIPMENT

Initially published on: October 22, 2019

Updated on: October 26, 2020

UPDATE: Deadline for the registration of Ultrasound scanners postponed by 12 months to November 1, 2021.  

India’s Central Drugs Standards Control Organization (CDSCO) has officially added ‘ultrasound equipment’ to the Notified list of medical devices that require pre-market approval in India. As seen in previous Notifications, the CDSCO is expected to release guidance of risk classification and generic intended use for ultrasound equipment.

Manufacturers and importers of these devices will need to obtain an Import Licenses (Form MD-15) under the Medical Device Rules, 2017 to maintain market access. Products without valid license may not be imported and marketed after November 1, 2020 (UPDATED: November 1, 2021).

Suggested actions:

  • Identify any devices in your portfolio that utilize ultrasound technology
  • Confirm if the intended use matches those listed in the CDSCO guidance document (when available)
  • Prepare for application submission for applicable devices no later than January 1, 2020 to ensure licenses are in place by November 1, 2020 (UPDATED: November 1, 2021).

The mandate was published in the Gazette of India on October 16th, 2019 by the Ministry of Health and Family Welfare (Department of Health and Family Welfare). The published announcement constitutes Gazetting, officially implementing the new policy.The resolution to regulate ultrasound equipment was originally raised 21 months earlier at the February 12th, 2018 Drugs Technical Advisory Board (DTAB) meeting.

Asia Actual has a strong regulatory team in India helping companies stay informed and navigate the regulatory changes in India’s dynamic and complex market. Please contact Asia Actual with questions or service inquiries.

Blog Posts

India Grants Import License Grace Period for Class A/B Devices

Released on September 30, 2022, the Central Drugs Standard Control Organisation (CDSCO) issued Circular File No. 29/Misc/03/2022-DC (257) providing an Import License grace period to all Non-Regulatory Class A and B medical devices.
Class A Exempt Instruments

India Issues Draft Notification for Exempting Certain Class A Medical Devices

The Indian Ministry of Health and Family Welfare (Department of Health and Family Welfare) issued the draft Notification G.S.R. 710(E) on 20 September, 2022 that, if formalized, would exempt Class A non-measuring and non-sterile medical devices.

Transfer of Product Registration of Alcohol Swabs from CDRRHR to CDRR

Announced on September 6, 2022, FDA Advisory 2022-1576, the Philippines FDA has announced that the alcohol swabs with at least 70% isopropyl alcohol intended for antiseptic use now falls under the jurisdiction of the Center for Drug Regulation Research (CDRR) under Household Remedy Products.