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High-risk medical gear makers get more time for licence compliance

The Drugs Controller General of India (DCGI) has announced that manufacturers and importers of high-risk medical devices who have applied for a license before September 30 can continue to supply them in the market for another six months. New regulations state that medical devices in the class C and class D categories cannot be sold without a license. Many manufacturers have applied for licenses but have not received them on time. The government s think tank, NITI Aayog, has recommended that all medical devices meet safety and quality standards.

Medical device makers get six-month extension for imports

The Central Drugs Standard Control Organisation (CDSCO) had set the October 1 deadline for bringing ‘class C and ‘class D medical devices under regulation as part of quality control efforts. To obtain the licences several manufacturers had submitted applications, but the government failed to provide them on time.

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