The Union Ministry of Health and Family Welfare has suggested changes to the Medical Devices Rules, 2017, aimed at reducing the time required to issue manufacturing licences for medical devices in various risk classes. The draft notification, released in the official gazette, intends to streamline and speed up the approval process while upholding standards for quality, safety, and performance, according to the ministry on Sunday. These changes focus on shortening approval periods across risk categories to support business operations, boost regulatory effectiveness, and ensure quicker access to reliable medical devices nationwide. Medical devices fall into four risk-based groups under the 2017 rules: Class A, Class B, Class C, and Class D, where Class D covers the highest-risk items. The rules set fixed periods for handling licence applications in each group. The proposals would shorten these periods to allow quicker approvals without lowering quality, safety, or performance benchmarks. For Class B devices, covering low to moderate risk items such as blood pressure monitors, hypodermic needles, and pulse oximeters, the suggested timeline drops from 140 days to 115 days. For Class C and Class D devices, including higher-risk products like cardiac stents, hip and knee implants, and other orthopaedic devices, the timeline would decrease from 105 days to 90 days. The draft also sets specific deadlines for each step in the process, such as application review, audits by notified bodies, compliance checks, and licence issuance. This aims to increase clarity, consistency, and speed in the regulatory system, helping manufacturers and patients gain faster access to verified devices. The draft notification is open for public feedback from stakeholders and can be found in the official gazette as well as on the Central Drugs Standard Control Organisation website. Comments must be submitted within the given timeframe.
