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Contact : Mr. D. L. Pandya
Classic Computer Services
B-4, Mandir Appt., Opp. P & T Colony, Jodhpur Char Rasta, Satellite Road, Ahmedabad-380 015. India.
Phone : +91 79 26740611 Telefax : +91 79 26754867
M : +91 9825457563
E-mail : mpds00@vsnl.com / dlpandya@gmail.com

Speakers Abstracts

Mr. Siddharth Jain
CEO and Chief Regulatory Advisor
Symbiorph Clinical Trialogy, Ahmedabad

Global Product Registration-Medical Device

Despite the significant presence of domestic players in the industry, the Indian medical devices market is still largely dependent on imports.

However, ‘Local innovation’ by MNCs as well as domestic players is expected to drive indigenous manufacturing and lead to rapid growth of exports.

Export of medical devices have grown at a rate of around 12% over the past five years, reaching a value of USD 1.2 billion in 2014. This indicates strong performance of the domestic manufacturing industry although limited in size. The Consumables and implants segment accounts for more than 40% of exports from India with USA being the leading destination of export of medical devices.

In the recent years, MNCs and domestic players have designed and developed India specific medical devices in their R&D centers located in India. These products have been designed to suit the needs of the developed market – in terms of product specifications and pricing. Interestingly, these products have also created demand in other developing markets outside India.

Challenges across multiple dimensions that were disablers to the export of indigenous medical devices need to be addressed. These include poor knowledge for country specific regulatory requirement, poor regulatory documentation and providing the Marketing Authorization to single distributors are some specific road blocker for Indian medical device export industries.