BIS Gives 6-Month Relief to Medical Device Makers – Here’s What It Means

In a recent update that has caught the attention of the entire healthcare industry, the Bureau of Indian Standards has issued a six-month extension of mandatory certification of some medical devices. This decision is a follow-up to the unfavourable plea by industries to have more time to comply with stringent quality and safety standards as stipulated by BIS Quality Control Order. Its aim in extension is to facilitate ease of compliance by manufacturers and importers, as well as ensure that only BIS-certified safe, performance, and reliable devices are introduced into the Indian markets

Why This Extension Matters

The medical device sector in India is rapidly growing, motivated by growing healthcare needs and government Programs to increase local manufacturing. However, BIS certification is mandatory for some categories of medical devices to ensure product quality, patient safety, and regulatory compliance.

The sudden execution of certification deadlines often puts manufacturers—especially small and medium enterprises—under pressure. The six-month relief provides:

• Extra time to complete testing and documentation
• Opportunity to clear existing inventory without compliance violations
• Better preparation for BIS audits and inspections

Understanding BIS Certification for Medical Devices

BIS certification is not just a formality—it is a mark of quality confidence that ensures the product meets the required safety, accuracy, and performance benchmarks. This is especially key for medical devices, where substandard products can compromise patient health and treatment outcomes.

Under the BIS QCO, certain medical devices must meet specific Indian Standards (IS codes) before they can be manufactured, imported, or sold in India. For example:

Medical Device	Applicable Standard (Example)
Blood Pressure Monitoring Equipment	IS/ISO 81060-1
Glucose Monitoring Systems	IS/ISO 15197
Sterile Surgical Gloves	IS 13422

Read More: BIS Certification For Medical Devices

Impact on Manufacturers and Importers

For domestic manufacturers, this extension allows more time to schedule testing, update labelling, and make necessary changes to product design.

For importers, it offers a chance to coordinate with foreign manufacturers to arrange product specifications with Indian standards, avoiding delivery rejections at customs.

However, experts caution that this is not a request to delay action—testing labs are likely to see a surge in demand closer to the new deadline, which could cause delays again.

BIS Certificate for Medical Device – A Quick Recap 

BIS certification ensures that a medical device meets the prescribed Indian Standards for safety

Performance and quality. Under the Quality Control Order issued by the Government of India, several medical devices must obtain BIS approval before being sold in the market 

Key Steps in BIS Certificate: 

1. Identify Applicable Standard – Each device must comply with a specific IS code.
2. Products Testing – Conducted at BIS-recognised labs.
3. Applicable Filing – Submit required documents via BIS online portal 
4. Factory Inspection – BIS officials verify manufacturing facilities.
5. Grant of License – Upon compliance confirmation, the BIS license is issued.

How Manufacturers Should Use This 6-Month Window

Ensures most of the ease period, manufacturers should:

1. Begin Product Testing Immediately – Submit samples to BIS-recognised labs to avoid last-minute delays.
2. Update Documentation – Make sure all test reports, Device Master Files, and quality certifications are up to date.
3. Review Labeling and Packaging – Ensure compliance with BIS and CDSCO labeling rules.
4. Train Internal Teams – Build awareness among quality and production staff about BIS requirements.
5. Work with Expert Consultants – Streamline the approval process by engaging professionals experienced in BIS compliance.

Who Benefits From This Extension?

The relief will benefit:

• Domestic manufacturers struggling with testing slot availability in BIS labs.
• Importers need time to align foreign-made products with Indian standards.
• SMEs & Startups with limited resources for immediate compliance.

What Medical Devices Are Covered?

The extension applies to device already notified under BIS Quality Control Order. This may include:

• Blood Pressure Monitoring Equipment 
• Glucose Monitoring System 
• Surgical Drapes and Gowns 
• Stents, Catheters, and Other Implantable Devices 
• Stents, Catheters, and Other Implantable Devices

Consequences Of Missing the New Deadline

After the extended deadline, selling non-certified products will be illegal. Violations can lead to:

• Products recalls 
• Penalties and fines 
• Loss of market credibility 

Final Thoughts

The 6-month relief from BIS gives 6-month relief to medical device makers is a planned opportunity for medical device makers to streamline compliance without disrupting market supply. Instead of waiting for the last few weeks, businesses should act now to ensure a smooth transition to BIS-certified operations.

If you need expert assistance in BIS certification for medical devices, ELT Corporate can help you with end-to-end service from identifying applicable standards to securing your BIS license.