India Revises Timelines for Manufacturing Medical Devices

The government of India has issued new license timelines for the manufacturing of medical devices. The new amendments proposed are expected to speed up licensing for manufacturers.

The Ministry of Health and Family Welfare has proposed these changes in the Medical Devices Rules, 2017. This aims to reduce the approval time and improve regulatory efficiency as well.

What led to the new proposal?

Medical Devices Rules, 2017 had a comprehensive risk-balanced classification, which is in to categories like Class A, B, C, and D. That is, based on categorizing from high-risk products to low-risk products. The medical devices were required to be licensed or registered through the Central Drug Standard Control Organization (CDSCO).

The current amendment proposed aims to cut short the time taken to grant licenses across various categories of medical devices. Therefore, at present, the categorization has been changed by dividing in to four categories.

For instance, the Class B medical devices include moderate-risk devices. Such as blood pressure monitors, hypodermic needles, and pulse oximeters. The specified timeline has been cut down from 140 days to 115 days.

This will range from high-risk products to low-risk products, like blood pressure monitors and implants. The government has made these changes while keeping the safety and quality of the products maintained and aligned.

Also Read: India’s Defense Manufacturing Opportunity & Evolving Policy Landscape

Changes according to New Policy Renewal

• Shrinking the timeline for licensing medical devices.
• Ensuring exact labeling on the product, offering transparency.
• Manufacturers must update the regulatory fee accurately.
• Actively monitoring post-market safety.

The New Parameters

For low-risk products, the timeline has been cut from 145 days to 115 days, which includes blood pressure monitors and pulse oximeters. Similarly, for high-risk products, the timeline is said to be shortened from 105 days to 90 days. Whereas this category includes cardiac stents and joint implants.

The Ministry quotes that, “the initiative aims to reduce the burden in business, improve regulatory efficiency, thereby ensuring the timely availability of medical devices, with promising quality in the country.”

The proposal also outlines clear stages for the licensing process, which include application, audit by notified bodies, compliance verification, and license issuance. The Ministry states that these measures are expected to improve transparency, predictability, and regulatory efficiency.

According to the Ministry, these proposed changes are expected to ease to both patients and manufacturing companies, as it releases the hurdles for companies and bring quicker medical service for the patients as well.