The Union Ministry of Health and Family Welfare on Sunday proposed amendments to the Medical Device Rules to speed up licensing approvals for medium to high-risk medical devices, according to people familiar with the matter.
“The Ministry of Health and Family Welfare has published a draft notification in the Official Gazette proposing amendments to the Medical Devices Rules, 2017, with the aim of simplifying and expediting the medical device licensing process while ensuring continued compliance with quality, safety and performance requirements.”
The draft notification has been issued based on suggestions made by the Drugs Technical Advisory Board (DTAB) after detailed consultation.
According to the Ministry of Health, the proposed amendments seek to rationalize timelines for granting licenses to manufacture medical devices across different risk categories.
The initiative also aims to enhance the ease of doing business, improve regulatory efficiency, and facilitate the timely availability of high-quality medical devices in the country.
Under the Medical Devices Rules 2017, medical devices are classified into four categories based on risk – Class A, Class B, Class C and Class D – with Class D comprising the highest risk devices.
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The rules set statutory timelines for processing manufacturers’ applications for manufacturing licenses for each category. The proposed amendments seek to reduce these timelines, thus enabling faster regulatory approvals while maintaining established standards of quality, safety and performance, the statement said.
For Class B medical devices, which include low- to moderate-risk devices such as blood pressure monitors, hypodermic needles and pulse oximeters, the timeline for granting a manufacturing license has been proposed to be reduced from 140 days to 115 days.
Likewise, for Class C and D medical devices, which include high-risk devices such as heart stents, hip and knee implants, and other orthopedic implants, the timeline for granting a manufacturing license has been proposed to be reduced from 105 days to 90 days.
For the Category A category, which includes low-risk devices such as medical thermometers and stethoscopes, there is no change.
The draft amendments also provide clearly defined timelines for each stage of the licensing process, including screening of applications, audit by notified bodies, compliance verification and issuance of licences.
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According to the draft notification, the applicant’s manufacturing site must comply with the requirements of the quality management system and will be verified through audit by a notified body before the license is granted. The State Licensing Authority ensures that the site audit is carried out by the registered body and that the audit report is duly submitted to the State Licensing Authority.
“This is expected to bring greater transparency, predictability and efficiency to the regulatory framework, benefiting the medical device industry and patients through faster access to quality-assured medical devices,” the Ministry of Health statement said.
The draft notification has been placed in the public domain for comments and suggestions from all stakeholders. The final notification will be published in the Indian Gazette after reviewing comments and suggestions.
