In an effort to enhance the clarity and efficiency of the approval process for manufacturing licenses in medical device sectors, the central government is planning revisions to the Medical Device Rules (MDR), 2017. These changes will incorporate specific timelines related to the issuance of manufacturing licenses for the four categorized medical devices in the nation.
By making these adjustments to the current regulations, the government aims to enhance industry transparency regarding the processes involved in securing manufacturing licenses.
The Drugs Technical Advisory Board (DTAB), during its meeting on August 14, 2024, considered and agreed on a prospective modification to incorporate these timeframes. This proposal encompasses timelines for state regulatory approvals for Class A and B devices and the central regulator’s validation for Class C and D devices.
Licensing for the production of Class A and Class B medical devices is overseen by the State Licensing Authority (SLA) as outlined in Rule 20 of MDR, 2017, which specifies the duration allowed for applications review, compliance of Quality Management System (QMS) audit pursuant to the Fifth Schedule.
However, the timeline specifying the audit execution and compliance verification of any previous non-conformance isn’t currently detailed within the rule, leading to QMS inspection and compliance confirmation delays by registered notified bodies for Class A and B devices. Consequently, the central authority has suggested amendments to Rule 20 of MDR, 2017.
According to the new proposal, the State Licensing Authority should decide whether to issue or deny a license for Class B medical devices within 45 days of receiving the application, while providing written reasons for any rejection. A provision suggests that if rectifiable deficiencies are identified and shared by the SLA within the given timeframe, the countdown restarts from the date those deficiencies are resolved. Additionally, the SLA must arrange an inspection by a registered notified body of the manufacturing site.
The proposal further demands that SLAs facilitate site audits by the registered notified body, per regulation, within 45 days of assigning applications. If the notified body’s audit reveals QMS non-compliance, verification must occur within 20 days from receiving the manufacturer’s compliance report. Completed audit reports should be submitted to the SLA within 15 days.
For Class C and D devices, however, despite rules prescribing application scrutiny and QMS inspection timelines, exact inspection scheduling wasn’t previously detailed.
To address this, regulators propose amending Sub-rule (1) of Rule 23 of MDR, 2017, to specify that Class C and D device manufacturing sites must be inspected within 60 days following application review by a team of at least two medical device officers. Initially, the mandate required site inspections within 60 days of application submission.
DTAB deliberated on these matters and endorsed the proposed MDR, 2017 amendment to incorporate timelines for manufacturing license issuance.
It’s noteworthy that as medical devices have been categorized as drugs, the government continues to revise and supplement these rules to strengthen the regulatory landscape. Additionally, in the same meeting, DTAB reviewed multiple other proposals concerning MDR, 2017 adjustments and manpower strategy improvements to better regulate the sector.