September 2014 Compliance Deadline for Indian Medical Device Labeling Rules

India’s drug and medical device market regulators will begin requiring importers to affix labeling information to their products before shipping to the country in September 2014.

The Drugs Controller General’s (India) Central Drugs Standard Control Organization (CDSCO) currently requires “India-specific” labeling to be attached to imported devices at their Indian ports of entry by distributors. India-specific labeling information should include importer and/or distributor names and Import License numbers.

In order to allow affected importers enough time to come into compliance, as well as to avoid any short-term shortages of medical devices in the Indian market, the CDSCO will begin enforcing the new label requirements starting September 28, 2014.

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