NEW DELHI: With the aim to simplify and expedite the licensing process for medical devices, the Union Health Ministry has issued draft notification proposing amendments in the rules, which will also ensure continued compliances with quality, safety and performance requirements.
The proposed amendments in the Medical Devices Rules, 2017, seek to rationalize the timelines for the grant of manufacturing licences for medical devices across different risk categories.
Among the devices, which fall under low to moderate risk devices like blood pressure monitors, hypodermic needles and pulse oximeters, the timeline for grant of manufacturing licence has been proposed to be reduced from 140 days to 115 days.
Similarly, for those devices which fall under high-risk devices such as cardiac stents, hip and knee implants, and other orthopaedic implants, the grant of manufacturing licence has been proposed to be reduced from 105 days to 90 days.
The initiative is aimed at enhancing the ease of doing business, improving regulatory efficiency, and facilitating the timely availability of quality medical devices in the country, officials said.
The ministry has published the draft notification in the official gazette proposing amendments to the Medical Devices Rules, 2017 and has sought suggestions and feedback from all stakeholders within 30 days.
The rules were published after consultation with the Drugs technical Advisory Board.
Under the Medical Devices Rules, 2017, medical devices are classified into four risk-based categories—Class A, Class B, Class C and Class D.
Class D comprises the highest-risk devices.
The Rules prescribe statutory timelines for processing applications for manufacturing licences for each category.
The proposed amendments seek to reduce these timelines, thus enabling faster regulatory approvals while maintaining the established standards of quality, safety and performance.
Officials said the draft amendments also introduce clearly defined timelines for each stage of the licensing process, including scrutiny of applications, audit by notified bodies, verification of compliance and issuance of licences.
The draft proposal states that the State Licensing Authority (SLA) will complete the scrutiny of the application in Class B devices, which are moderate risk devices, and will assign it to notified bodies within a period of 30 days from the date of online submission of application.
It also proposes that the manufacturing site of the applicant should conform to Quality Management System (QMS) requirements as specified under the Fifth Schedule and all applicable standards as specified under these rules. It adds that this conformity must be verified through an audit by a notified body under rule 13 before licence is granted.
It also states that the SLA will ensure that the audit of the site is carried out by the registered notified body within a period of 30 days from the date it was assigned. The audit report has to be submitted to the SLA. Further, in case of non-conformance of QMS requirements found during the audit, the compliance verification should be carried out within 20 from the date of receipt of compliance report from the manufacturer.
It further specifies that the notified body has to submit its final report along with the recommendations to the SLA within 15 days of the completion of the audit.
For Class C and Class D medical devices, which include high-risk devices, the timeline for granting manufacturing licence has been proposed to be reduced from 105 days to 90 days.
Officials added that the amendments are expected to bring greater transparency, predictability and efficiency to the regulatory framework, benefiting both the medical device industry and patients through faster access to quality-assured medical devices.
