CDSCO Extends Deadline for Class C & D Medical Devices Cos by 3 Months

The move addresses concerns raised by stakeholders regarding potential disruptions to business operations following the implementation of the mandatory licensing regime on October 1, 2023.

The Central Drugs Standard Control Organisation (CDSCO) has extended the deadline for Class C and D medical device companies, allowing them to continue operations for three months despite pending license applications.

The Drugs Controller General of India (DCGI), Dr Rajeev Singh Raghuvanshi, informed us of the development, which, according to him, ensures the industry's business continuity amidst regulatory transitions.

Facing teething troubles in the licensing process, the medical device sector welcomed the CDSCO's decision to grant an extended grace period.

The move addresses concerns raised by stakeholders regarding potential disruptions to business operations following the implementation of the mandatory licensing regime on October 1, 2023.

"If an existing importer/manufacturer submits an application on or before September 30, 2023, the said application shall be deemed valid, allowing continued importation or manufacturing for up to three months or until a decision is reached by the Central Licensing Authority," the DCGI stated.

Challenges in Regulatory Transition

The transition to a licensing regime for medical devices has been marked by challenges, including the availability of quality testing laboratories nationwide and initial shortages of skilled manpower.

Concerns have been raised regarding the high fee structure for licensing and testing, particularly impacting micro and small-scale manufacturers.

Regarding these challenges, industry stakeholders have urged for streamlined processes and more accessible resources to facilitate compliance with regulatory requirements.

Emphasis on Timely Compliance

In a recent circular, CDSCO highlighted the importance of timely payment of license retention fees and registration certificates under the Medical Devices Rules (MDR), 2017.

Failure to comply with fee payment deadlines may result in the suspension or cancellation of licenses or certificates, noted CDSCO.

The reminder is a proactive measure to prevent medical device manufacturing, importation, and quality management disruptions due to non-compliance with regulatory obligations.

Focus on Adverse Event Reporting

As part of the transition to a licensing regime, CDSCO issued directives urging stakeholders to ensure timely reporting of adverse events related to medical devices to the Materiovigilance Programme of India (MvPI).

This initiative underscores the commitment to monitoring and enhancing post-market surveillance to safeguard public health.

Under the current regulatory framework, all medical devices, including in-vitro diagnostic devices, are regulated by the Drugs and Cosmetics Act, 1940, and Medical Devices Rules, 2017.

The phased implementation of mandatory licensing aims to strengthen regulatory oversight and enhance the quality and safety standards of medical devices available in the market.

Further, CDSCO's decision to extend the deadline for Class C and D medical devices offers a reprieve for industry players amidst regulatory uncertainties.

However, stakeholders are reminded of the need to comply with regulatory requirements on time to maintain the integrity and safety of medical devices in the market.