India Extends Deadline for Device Labeling Rules

May 17, 2017

Devicemakers importing products into India will have six more months to comply with new device labeling rules.

New labeling rules for imported devices were scheduled to take effect May 25, but devicemakers requested an extension of the requirements, which will now take effect on Jan. 1, 2018.

The Drugs Controller General of India said international labeling rules requiring the expiration date and date of manufacture on the device label conflicted with India’s labeling requirements. As a result, importers will be allowed to affix a sticker indicating the manufacturing date and expiration date on device labels.

India recently finalized new regulations that separate out devices for the first time from broader drug regulations, which also go into effect on Jan. 1, 2018. Previously, device manufacturers had to comply with regulations written for pharmaceuticals.

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