Indian Regulators, Medical Device Associations Focus on New Guidelines, Increasing Exports

Posted 11 December 2015 | By Zachary Brennan 

Indian Regulators, Medical Device Associations Focus on New Guidelines, Increasing Exports

India’s Ministry of Health and Family Welfare (MOHFW) and the Central Drugs Standard Control Organization (CDSCO) met with medical device association representatives earlier this month to discuss how the country can become a hub for device manufacturing and begin to align with global regulations.

According to the minutes of the meeting, most of the discussion centered on increasing device exports and evaluating new guidance for industry.

Draft guidance on good manufacturing practices and facility requirements, known as Schedule MIII, which was originally prepared back in 2014, was re-circulated and the government bodies requested that the associations offer further comment on the draft by 14 December.

The Association of Indian Medical Device Industry also circulated draft guidance documents on:

  • Initial Factory Audit of Quality Management System & Infrastructure.
  • Export Labeling, Additional Brand, Neutral Code, Free Sales Certificate
  • Clarification for Import and Sale of Non-sterile Assembled Devices (Bulk)
  • Clarification for Clinical Evaluation and Adverse Event Reporting

Free Sale Certificates

Discussions between the associations and CDSCO also centered on the use of free sales certificates, which countries often require from foreign manufacturers to show that products are approved.

Both sides agreed that “a circular may be issued to all State Licensing Authorities by Drugs Controller General (India) for extending the validity from of Free Sale Certificate from 2 years to 5 years subject to the validity of manufacturing license held by the firm,” according to the meeting minutes.

In addition, regulators will also begin charging manufacturers a fee of Rs. 5000 ($74) per application to obtain the certificates from the state licensing authorities.

Associations also raised concerns that Indian manufacturers were losing considerable export opportunities for devices because these certificates “have not been notified as drugs by the Ministry of Health and Family Welfare,” which is required by many importing countries.

After discussions, both sides agreed that a new online database could be created to allow for basic information on manufacturers to be included to ensure “the authenticity of the manufacturer,” which would need to have at minimum some degree of quality management system compliance.

Discussions on India Medical Devices

Categories: Regulatory News

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