India Medical Device Labeling

Medical device labeling requirements in India are prescribed in Chapter VI of the Medical Devices Rules, 2017. Most of the requirements are and can be addressed by international medical device labeling requirements. However, requirements specific to India include:

1. Device registration number
2. Contact specifics of the initial importer
3. Local customer contact telephone number
4. Manufacturer Suggested Retail Price (MSR)
5. Batch/lot number

As per regulations, registered medical devices must have India-specific labeling affixed prior to clearance by the Indian Customs office. However, it had been common practice for Customs to release a shipment without local labeling if the importer provided a Letter of Guarantee (LG), committing to meet labeling requirements after Customs clearance. This practice is now unreliable.

Per G.S.R. 30, which went into effect on January 15, 2019, Electronic IFUs are now accepted by the CDSCO. Instructions for use can be provided as an electronic format downloadable from the internet.

Asia Actual has established a system for the local labeling of registered medical devices in India prior to customs clearance. This service is available to companies that cannot or do not wish to apply India-specific labeling at their factory.

Asia Actual can also provide local labeling services for shipments that have been sequestered at Customs, but only if customs duties have not yet been paid.
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Contact Asia Actual to see if our India labeling solutions are right for your needs.