Six-month extension for high-risk medical device licensing

A six-month extension has been granted for the compulsory licensing requirements associated with the production of Class C and D medical devices, which are commonly known as high-risk medical devices in non-medical terminology.

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The mandatory licensing norms which are used for the production of Class C and D medical devices, often colloquially termed high-risk medical devices outside of medical jargon, have been prolonged by six months.

The extension implies that if a manufacturer or importer has already applied for the license and inspections have not been conducted by the authorities up to this point, they are permitted to continue manufacturing or importing these devices for an additional six months.

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

The primary objective of these new regulations was to enhance the quality control standards for Class C and Class D medical devices. Such devices encompass a range of equipment, including ventilators, imaging equipment, nebulizers, x-ray machines, surgical robots, linear accelerators used in oncology, and oxygen therapy equipment.

Medical device equipment manufacturers had submitted a petition to the Central government, urging them to enforce compliance with the obligatory licensing regulations. Their request for an extension was based on the resource limitations faced by the Central Drugs Standard Control Organisation, making it challenging to conduct inspections and issue manufacturing licenses within the originally set deadline.

Class A and B devices have been subject to regulation since April 1, and manufacturers who were registered but hadn’t obtained licenses by that date were permitted to continue their manufacturing and sales activities. This was allowed while State and Central government regulators pursued compliance and conducted audit certifications.