Mandatory licensing norms for manufacture of Class C and D medical devices — also called high risk medical devices in non-medical parlance — has been extended by six months.

What this effectively means is now, a manufacturer or importer, if he has applied for the licence, and inspections have not carried out by the authorities so far, will continue to manufacture or import the devices for six months.

Under the New Medical Devices Regulations, 2020, manufacturers were given a transition period of 42 months, starting from April 1, 2020, to complete the licensing of non-notified Class C and D medical devices.

The new rules were aimed at enhancing the quality control of Class C and Class D medical devices. Devices which would come under the purview include ventilators, imaging equipment, nebulizers, x-ray, surgical robots and linear accelerators which are used in oncology and oxygen therapy equipment.

Plea to Centre

Medical device equipment-makers had petitioned to the Centre to ensure compliance to the mandatory licensing norms.

Additional time was sought on the grounds of resource constraints of the Central Drugs Standard Control Organisation in conducting timely inspections and issuing manufacturing licences before the previously stipulated deadline.

The Class A and B devices have been regulated since April 1, and manufacturers who were registered but not licensed on April 1 were allowed to continue manufacturing and selling while State and Central government regulators sought compliance and audit certification.

In a circular dated October 12, the Ministry of Health and Family Welfare clarified that an existing importer or manufacturer — who is already importing and manufacturing — of Class C and Class D devices, and has already submitted an application will continue to import or manufacture the said device or devices for another six months or “till the time the licensing authority takes a decision on the application” (whichever is earlier).

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