India Overhauls Medical Device Marking Rules, Introducing E-Labeling and New Fee Structure

India’s medical device market is facing a significant regulatory shift following new rules published by the Bureau of Indian Standards (BIS) that modernize labeling requirements while tightening compliance for manufacturers. The changes, detailed in the Bureau of Indian Standards (Conformity Assessment) Amendment Regulations, 2026, introduce both digital-friendly options and stricter physical marking standards that will impact all medical device makers selling in the country.

According to a report from Morulaa HealthTech, a key change for manufacturers registered under Scheme-II is the introduction of specific technical requirements for the ‘Standard Mark’. In a nod to technological advancement, the regulations now permit the use of e-labelling. This allows the mandatory Standard Mark to be presented electronically on devices that have an integrated display screen, forgoing the need for a physical mark.

However, for devices requiring a physical label, the rules have become more stringent. The amendment mandates that the mark must be easily visible and legible, specifying the use of Arial font at a minimum size of 6. This requirement will force manufacturers to review and potentially redesign their current physical labeling processes to ensure compliance.

Perhaps the most significant business impact comes from a change in how licenses are maintained. The amendment moves the system to an annual advance fee structure for the maintenance of licenses and certificates. As reported by Morulaa HealthTech, failure to pay this fee on time could lead to severe consequences, including the suspension or outright cancellation of a company’s right to sell its products in the vast Indian market. This change requires medical device firms to adapt their financial planning and administrative processes to avoid disruptions to their operations in India.