The Indian government has added a section on the suspension and cancellation of licenses to the Medical Devices Rules, 2017 to empower regulators to act when companies break the rules.
In the new section, the government describes what happens when, “The manufacturer or licensee fails to comply with any of the conditions of an import license, or any provisions of the Act and these rules.” If that happens, the central licensing authority will give the licensee a chance to set out why it should not pass an order against the organization for noncompliance.
Licensees that fail to successfully argue their case could face the cancellation or suspension of regulatory licenses. The suspension can last for as long as the central licensing authority sees fit and may apply “either wholly or in respect of any of the part of medical device.”
Affected licensees may have to stop the import, sale or distribution of their medical devices and destroy their stock in the presence of an officer authorized by the central licensing authority. The licensee can appeal the ruling to the central government within 30 days of receiving the order.
The final text is largely unchanged from the draft version released for consultation earlier this year.
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