Update on India

The requirements for medical device regulation in India continue to evolve.  The Indian Central Drugs Standard Control Organization have recently published the draft Guidance Document on Common Submission Format for Registration of Medical Devices in India.  This guidance sets out in detail the expectations of the Indian authorities for Device technical file, manufacturing information and certifications that must be submitted in support of Indian licensing application.  The content is based very much on the AHWP CSTD template and the GHTF STED.  The Submission requires specific information on overseas regulatory status - including both product registrations AND postmarket history.  This reflects a trend for emerging jurisdictions to look specifically at the overseas postmarket track record of new products. 

Arthur Brandwood
Arthur@brandwoodbiomedical.com.au