The Ministry of Consumer Affairs, through the Bureau of Indian Standards, has officially published the Bureau of Indian Standards (Conformity Assessment) Amendment Regulations, 2026. This update marks a significant shift in how licenses and certificates are maintained, moving toward a proactive, annual “subscription” model for compliance. For medical device manufacturers, these changes are important. Failure to align with the new payment and reporting timelines could lead to immediate suspension or cancellation of your right to sell in the Indian market.
BUREAU OF INDIAN STANDARDS KEY HIGHLIGHTS OF THE 2026 AMENDMENT
The amendment is about ensuring clear financial responsibility and ongoing monitoring. Here are the main parts of the new rule:
1. The Annual Advance Fee Structure
BIS has replaced periodic payments with an annual advance requirement. Pay Upfront: Fees for the grant and continuation of a license must now be paid annually in advance. Production Statements: Licensees must pay annual dues within specified timelines along with a production statement. Renewal Synchronization: Fees must be paid on an annual basis in advance at the time of renewal and for the continuation of a valid license thereafter.
2. Suspension and the 90-Day “Grace” Period
The consequences for missing a deadline are now automated. Automatic Suspension: If the annual fee and production statement are not received by the due date, the license or certificate of conformity stands suspended for 90 days. Late Fee Penalty: To revoke a suspension within this window, manufacturers must pay the outstanding dues plus a late fee of ₹5,000. Mandatory Cancellation: If the annual fee and production statement are not received within the suspension period, the license or certificate shall be cancelled.
3. New Benefits for MSMEs and Start-ups
To support the domestic medical technology ecosystem, the Bureau has introduced significant fee concessions valid until May 31, 2029:
- Micro Enterprises & Start-ups: 80% concession on processing fees.
- Small Enterprises: 50% concession.
- Medium Enterprises: 20% concession.
IMPACT ON MEDICAL DEVICE LABELING (SCHEME-II)
If your devices are registered under Scheme-II (Registration based on self-declaration of conformity), the 2026 guidelines provide specific technical requirements for the “Standard Mark”:
- Display Requirements: The mark must be easily visible on the article, packaging, or as specified by the Bureau.
- Font Specifics: Display of reference to Indian Standards, registration numbers, and words must use Arial font and be at least size 6.
- E-Labelling: Devices with integrated display screens may now present the Standard Mark electronically (e-labelling) instead of a physical presentation.
Detailed dimensions for the SDoC mark are now strictly defined in millimeters, including specific ratios for the “S” monogram and surrounding frame.
WHAT MANUFACTURERS SHOULD DO NOW
Check the expiration and due dates for your current license. Be aware that the 90-day suspension period is strict under the new regulations. Ensure your production data is ready alongside your annual budget for BIS fees, keeping finance and production aligned. For foreign manufacturers, confirm that your Authorized Representative in India is active and authorized to sign the new Form-III affidavits. If you qualify for new concessions, make sure your MSME status is properly documented to take advantage of up to 80% off processing fees.
HOW MORULAA CAN HELP
Navigating the transition from periodic renewals to annual advance compliance can be complex. At Morula HealthTech, we are your trusted partner in ensuring success in the intricate world of medical device compliance. We specialize in medical device regulatory compliance in India, assisting companies with the complex process of product registration and medical device importation. Our expertise spans the entire lifecycle, from market access to distribution, ensuring that your products reach their full potential in the Indian market. We offer comprehensive services such as Annual Compliance Management, where we track your production statements and fee deadlines to help you avoid automatic suspensions. Additionally, we provide AIR Services, acting as your Authorized Indian Representative to handle legal affidavits and Bureau correspondence. We also assist with Labeling Reviews to ensure your physical and e-labels meet the strict Arial-6 font and proportion requirements of the 2026 Gazette. However, our reach doesn’t stop in India. We also offer tailored staffing solutions and AI-based registration services across Europe, the USA, the Middle East, Asia, Africa, and South America.