New Delhi, June 28 (HS): The Central Government has proposed amendments to the Medical Devices Rules, 2017 to expedite and simplify the process of granting manufacturing licences for medical devices. The proposed changes seek to reduce the licensing timeline for Class B medical devices from 140 days to 115 days and for Class C and Class D devices from 105 days to 90 days.

According to the Ministry of Health and Family Welfare, the draft amendments are aimed at promoting ease of doing business, making the regulatory process more efficient and ensuring the timely availability of quality medical devices in the country, while maintaining the existing standards relating to quality, safety and performance.

Under the existing rules, medical devices are classified into Class A, Class B, Class C and Class D categories based on the level of risk, with Class D representing the highest-risk category. Separate timelines have been prescribed for processing manufacturing licence applications for each category.

The proposed amendments provide for reducing the licensing timeline for Class B devices, which include low- to moderate-risk products such as blood pressure monitors, hypodermic needles and pulse oximeters, from 140 days to 115 days.

Similarly, the licensing timeline for Class C and Class D medical devices has been proposed to be reduced from 105 days to 90 days. These categories include high-risk medical devices such as cardiac stents, hip and knee implants and other orthopaedic implants.

The draft amendments also propose clearly defined timelines for every stage of the licensing process, including scrutiny of applications, audits by notified bodies, compliance verification and issuance of licences. The Ministry said the changes would enhance transparency, predictability and efficiency in the regulatory framework, benefiting both the medical device industry and patients.

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Hindusthan Samachar / Jun Sarkar