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INDIA SETS REGISTRATION DEADLINE FOR ULTRASOUND EQUIPMENT

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.

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

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 us here with questions or service inquiries.  

INDIA PLANS TO REGULATE ALL MEDICAL DEVICES

At the April 2nd DTAB meeting, the DCGI presented a proposal to regulate all medical devices over a 42-month period. Non-Notified devices would require registration in a phased in approach. This would allow an 18-month voluntary registration period after which class A and B devices would have 12 months to obtain an Import License (MD Form 15) prior to importation.  Class C and D devices would have 24 months to meet the same requirement.

Implementation could happen quickly. The proposed plan closely matches details that were discussed at a meeting hosted by the Central Drugs Standard Control Organization (CDSCO) held on February 8, 2019 with industry stakeholders.  Once the plan is endorsed by the DTAB, the MOHFW is expected to establish the implementation date quickly. Perhaps as early as the third quarter of 2019.

Voluntary registration would involve typical administrative documents such as reference country approval certificate, ISO 13485 certificate, etc.  The voluntary Registration Certificate carries no processing fee and no expiry date.  However, once registered the local license holder would be required notify the CDSCO and Materiovigilance Programme of India (MvPi) of Serious Adverse Events (SEA) occurring in India.

The CDSCO review process to generate a MD Form 15 typically takes 6 to 9 months with 6 to 8 weeks of application preparation. To be safe, manufacturers should begin the MD Form 15 application process 12 months before any deadline.

Manufacturers of non-Notified medical devices are advised to evaluate their products of interest for India and begin to build their application files for a Registration Certificate and Import License.

Asia Actual is available to answer questions or help register your devices when the new requirements take effect. Contact us to arrange an initial conversation.

INDIA TO REGULATE SURGICAL DRAPES AND GOWNS

At the April 2nd Drugs Technical Advisory Board (DTAB) meeting, the board deliberated upon and agreed to add (1) surgical gowns, (2) surgical drapes, and (3) incision drapes to the list of notified medical devices requiring registration with the Central Drugs Standards Control Organization (CDSCO) in India.

Next the Ministry of Health and Family Welfare must issue a Gazette Notification for the requirement to become official. Based on past experience,  it is expected to take approximately 5 months from a positive DTAB board resolution to Notification with a likely 12-month transition period for compliance. Manufacturers of these devices should take urgent action to prepare registration applications to maintain access to the Indian market.

Asia Actual has a strong regulatory team in Delhi to help companies stay informed and ahead of regulatory changes. Visit our market info page for the most up-to-date list of notified medical devices requiring registration.

We also provide efficient, transparent management of medical device regulatory, vigilance and importing activities in this dynamic market.

Please contact us with questions or service inquiries.Attachments area