New Delhi, 28 June (H.S.):

The Central Government has proposed amendments to the Medical Devices Rules, 2017, aimed at making the manufacturing licence approval process for medical devices faster and more streamlined. Under the draft amendments, the timeline for issuing manufacturing licences for Class B medical devices is proposed to be reduced from 140 days to 115 days, while the approval period for Class C and Class D devices is proposed to be shortened from 105 days to 90 days.

According to the Ministry of Health and Family Welfare, the proposed changes are intended to improve the ease of doing business, enhance the efficiency of the regulatory framework, and ensure the timely availability of high-quality medical devices across the country. The ministry said the existing standards relating to quality, safety, and performance would remain unchanged.

Under the current Medical Devices Rules, medical devices are classified into four categories—Class A, Class B, Class C, and Class D—based on the level of risk they pose. Class D devices are considered the highest-risk category, and separate timelines have been prescribed for processing manufacturing licence applications for each class.

As part of the proposed amendments, the approval period for manufacturing licences of Class B medical devices would be reduced from 140 days to 115 days. This category includes low- to moderate-risk devices such as blood pressure monitors, hypodermic needles, and pulse oximeters.

Similarly, the processing time for manufacturing licences of Class C and Class D medical devices is 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 application scrutiny, audits by notified bodies, compliance verification, and the final issuance of licences. The government said these measures are expected to improve transparency, predictability, and efficiency within the regulatory framework while benefiting both the medical device industry and patients.

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Hindusthan Samachar / Jun Sarkar