To streamline the approval process for granting manufacturing licenses to medical device units, the Central Government is considering amendments to the Medical Device Rules (MDR), 2017. These changes aim to introduce specific timelines for granting licenses for the four classes of medical devices, ensuring greater transparency and efficiency in the approval process.
The proposed amendments, endorsed by the Drugs Technical Advisory Board (DTAB) during its meeting on August 14, 2024, outline timelines for approvals by both state and central regulators. The state regulators handle approvals for Class A and B devices, while the central regulator oversees Class C and D devices.
Changes Proposed for Class A and B Devices
Under Rule 20 of MDR, 2017, the State Licensing Authority (SLA) is responsible for granting manufacturing licenses for Class A and B devices. While the rule currently prescribes procedures for application review and compliance audits of the Quality Management System (QMS) as per the Fifth Schedule, it lacks specific timelines for conducting audits and verifying compliance in cases of non-conformance. This gap often delays inspections and compliance checks.
To address these issues, the proposed amendments to Rule 20 include:
Decision Timeline: SLAs must decide on granting or rejecting licenses for Class B devices within 45 days of receiving the application, recording reasons in writing for any rejection. If deficiencies are identified, the timeline will restart once the deficiencies are rectified.
Audit Timeline: Registered notified bodies must conduct manufacturing site audits within 45 days of being assigned the application.
Compliance Verification: For non-conformance issues identified during audits, compliance verification must be completed within 20 days of receiving the manufacturer’s compliance report. Notified bodies are required to submit audit reports to the SLA within 15 days of completing the audit.
Amendments for Class C and D Devices
Class C and D devices are governed by Rule 23 of MDR, 2017. While existing rules specify timelines for application scrutiny and QMS compliance inspections, they do not define deadlines for site inspections.
The proposed amendment to Sub-rule (1) of Rule 23 mandates:
Inspection Timeline: Manufacturing sites for Class C and D devices must be inspected by a team of at least two medical device officers within 60 days of application scrutiny. This replaces the earlier provision of inspecting sites within 60 days of receiving the application.
Broader Regulatory Reforms
These changes are part of the government’s ongoing efforts to enhance the regulatory framework for medical devices, which were categorized as “drugs” under the law. The DTAB has also discussed other proposals to amend the MDR, 2017, and address manpower requirements to better regulate the medical device sector.
As reported by pharmabiz.com, by introducing these amendments, the government seeks to improve operational clarity and expedite the approval process, ultimately fostering a more supportive environment for the medical device industry.