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MTaI Statement On Ministry of Health Gazette Notification

“The Health Ministry’s proposal to regulate all medical devices will allow Indian patient the access to quality medical devices also and put a check on garage manufacturing. CDSCO under the Ministry of Health & Family Welfare has the most experience and over time have built the expertise to regulate this intricate medical device sector. Bringing all medical devices under regulation has been a long-pending demand from the industry and it is encouraging to see the government taking cognizance of industry concerns.

The domestic industry would also benefit from this regulatory pathway, as compliance with global standards will open up access to global markets for more domestic manufacturers-and not just the big ones. This Global
harmonization (for which a liberal adjustment time is being given), will go a long way in encouraging foreign investments -facilitating Make in India. It will also boost FDI which had recently fallen drastically in this sector”

Pavan Choudary, Director General and Chairman, Medical Technology association of India (MTaI)