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- BIS for medical devices provides a level of safety, compliance, and trust to consumers in India.
- Certain medical devices may require mandatory BIS registration under the BIS Compulsory Registration Scheme (BIS CRS).
- Diligence Certifications provides a complete end-to-end support for registering BIS for medical devices, testing of the products and liaising with BIS upon approval.
- The BIS registration certification process includes product testing in laboratories, submitting documents, site visits/audits, and marking the product.
- Failure to comply with BIS registration will permit products from entering India, including revoked import licenses.
Introduction
A medical device importer for Mumbai recently had all of their goods, an entire shipment of digital thermometers, held at customs. The reason? No BIS Certification. The devices were reputable, qualified products from a company both imported from and exported to several countries. However, the devices could not legally enter the Indian market. This is not a bureaucratic hold up — it is a regulatory requirement to protect safety, quality, and accountability for consumers.
Incidents such as this are inevitably going to become more and more frequent, as India tightens compliance norms for medical devices. If you are a medical device manufacturer, importer, or distributor, understanding BIS Certificate for Medical Devices is not just an afterthought, it has become a requirement.
At Diligence Certifications, we’ve worked with both Indian and global brands, helping them avoid costly delays and penalties. Whether it’s an automatic blood pressure monitor or an X-ray machine, we handle the BIS process so you can focus on what matters: innovation and delivery.
What is BIS Certification for Medical Devices?
The BIS Certification for medical devices is meant to satisfy the regulatory requirement of the Bureau of Indian Standards BIS for medical devices sold or used in India. This is the responsibility of the Bureau of Indian Standards to make sure medical devices that are sold or used in India meet certain safety and quality specifications. This is necessary to protect the patient from faulty, substandard or unsafe equipment
In accordance with the Compulsory Registration Scheme (CRS), medical devices – or more importantly electronic medical devices – cannot be sold, distributed or imported into India if they do not go through a particular testing and certification process under the BIS Testing and Certification Scheme.
It should also be noted that the BIS certification should not be confused with general quality certifications where other countries may have similar specifications, though BIS also sets specifications but typically focus on Indian Standard Specifications (IS) which are qualified against Indian Standards Specification for use in India. An example could be an import ECG machine, which must meet IS 13450 to be acceptable to the BIS.
Whether this is particularly medical device which is imported, domestically manufactured, or newly available into the Indian healthcare market, getting a BIS certification for medical devices is not a negotiable issue.
Categories of Medical Devices Under BIS Scope
Not all medical devices fall under BIS, but several electronic and diagnostic equipment types are covered. As of the latest BIS list, some commonly regulated products include:
- Digital Thermometers (IS 3055)
- Pulse Oximeters (IS 13450)
- Blood Pressure Measuring Equipment (IS 1060)
- Glucometers
- Ultrasound Equipment
- X-ray Machines
- MRI and CT Scanners
- Automated External Defibrillators
Each category is associated with a relevant Indian Standard (IS). Before starting the certification process, it’s important to identify whether your product type falls under CRS and which IS applies. At Diligence Certifications, we help you assess this fit accurately to avoid rejections.
If your product is not yet listed but expected to fall under future regulation, voluntary BIS Certification can be pursued as a proactive step — this also builds buyer trust.
ISI Mark vs FMCS for Medical Devices
BIS offers two main certification routes:
1. ISI Mark Certification (For Indian Manufacturers)
For devices manufactured within India, the ISI mark is granted after product testing from BIS-recognised labs and factory audits. This is a standard domestic route.
2. FMCS (Foreign Manufacturer Certification Scheme)
Foreign manufacturers must apply under FMCS, which includes stringent factory audits, testing from BIS-designated labs in India, and direct coordination with BIS.
At Diligence Certifications, we handle both routes, ensuring:
- Factory inspection readiness
- Pre- and post-audit documentation
- Sample testing as per IS codes
In both cases, the BIS certification for medical devices ensures legal market access, better brand perception, and compliance during import or sales audits.
Step-by-Step BIS Certification Process for Medical Devices
Getting BIS certification for medical devices is a procedural task involving regulatory, technical, and documentation checkpoints. At Diligence Certifications, we simplify it into these 7 core steps:
Step 1: Product Categorization
We first identify the IS code applicable to your device. This determines the test requirements, documents, and BIS route (ISI or FMCS).
Step 2: Documentation Preparation
Compile all necessary legal and technical documents such as business registration, device manuals, test protocols, prior certifications (if any), and product photos.
Step 3: Sample Testing
Product samples are sent to BIS-recognised labs in India for testing. The test checks compliance with applicable IS standards.
Step 4: BIS Portal Filing
We create your manufacturer profile, upload all documents, submit test reports, and pay the necessary BIS fees.
Step 5: Factory Audit (If Required)
For both FMCS and ISI, BIS may conduct an audit of the production site. We prepare you for the audit and assist during the on-ground process.
Step 6: Certification Approval
If the application and inspection pass, BIS grants the certification. Your device now receives a license number and can bear the BIS Standard Mark.
Step 7: Market Entry Support
We help with packaging, labeling (as per BIS), and compliance handholding for shipments and marketing.
From application to approval, our role is to make BIS certification for medical devices seamless, error-free, and quick.
Documents Required for BIS Certification for Medical Devices (ISI & FMCS)
Documents Required for ISI Certification (For Indian Manufacturers)
- Certificate of Registration and registered address proof of the manufacturing unit
- BIS-authorised laboratory test reports of the medical device
- List of all testing equipment installed on the premises
- Manufacturing process flowchart
- Government-approved ID proofs of authorised signatory
- Trademark Registration Certificate
- Recent utility bills (electricity/water) as operational proof
Documents Required for FMCS Certification (For Foreign Manufacturers)
- Factory registration and incorporation proof
- Detailed manufacturing process and flow chart
- Manufacturing capacity or outsourcing agreements
- On-site testing facilities and equipment list
- Internal quality control procedures and systems
- BIS-approved product test reports from Indian labs
- Identity proof and declaration from the authorised representative
These documents provide the backbone for verifying product authenticity, manufacturing standards, and regulatory compliance.
BIS Certification Workflow (Side-by-Side: ISI vs FMCS)
ISI Certification Process (Indian Manufacturers):
- Application form submission
- Factory inspection and infrastructure audit
- Product sample withdrawal for BIS lab testing
- Sample test report evaluation
- Certification granted if all standards are met
FMCS Certification Process (Foreign Manufacturers):
- Application submission and payment of requisite fee
- BIS audit of the foreign manufacturing facility
- Product sample collection for Indian BIS lab testing
- Evaluation of test results and audit observations
- License fee and marking fee payment
- Grant of BIS License issued upon compliance
Whether domestic or global, Diligence Certifications handles the full BIS certification for medical devices with precision and end-to-end support.
Why Choose Diligence Certifications for BIS Compliance?
At Diligence Certifications, we don’t just file paperwork — we provide full-spectrum consultancy to ensure your medical devices get BIS certified the first time, without delays or errors.
We’ve worked with:
- A Noida-based startup launching its first portable ECG monitor
- A European brand importing digital thermometers for pan-India retail
- An Indian manufacturer exporting BP monitors across South Asia
In every case, our experts:
- Identified applicable IS standards
- Coordinated testing with BIS-approved labs
- Handled factory audits and BIS communication
- Trained staff on BIS labeling requirements
Our edge lies in our experience, up-to-date regulatory knowledge, and dedicated support team. With us, you’re not navigating the BIS system alone.
Common Challenges and How We Solve Them
Challenge 1: Unclear Product Classification
Many businesses don’t know whether their product falls under BIS or not. We evaluate this accurately and share documented proof.
Challenge 2: Testing Delays
Lab backlogs can delay sample testing. We help prioritize your batch using relationships with top BIS-accredited labs.
Challenge 3: Failed Factory Audits
Small gaps in quality controls often lead to failed audits. We pre-audit your facility and resolve all red flags beforehand.
Challenge 4: Miscommunication with BIS Officials
BIS language can be complex. We handle all correspondence, translate technicalities, and ensure your responses are correct and timely.
Challenge 5: Cost Overruns
We give a clear budget upfront and help you avoid reapplication, penalties, or additional tests due to errors.
With Diligence Certifications, these obstacles turn into minor checkpoints.
Cost & Timeline for BIS Certification
The cost of BIS certification for medical devices depends on the certification route (ISI or FMCS), testing fees, number of product categories, and BIS licensing charges. On average:
- Testing fees per product category.
- BIS application fees
- Additional charges apply for audits (especially FMCS) and document verifications.
Timelines:
- ISI Certification: 30–60 days
- FMCS Certification: 60–90 days (including factory audit coordination)
We provide fixed quotes after assessing your device type, helping you avoid hidden costs and ensuring a smooth budgeting process.
Conclusion
BIS Certification for medical devices is about so much more than regulation — it is a promise of trust, quality, and accountability in India’s developing healthcare space.
Diligence Certifications can help you make the process straightforward, accurate, and cost-effective. We assess your product for BIS certification, we manage the BIS portal, facilitate testing, support your audits, and manage your renewal — we work with you as your certification partner.
Whether you’re a first time importer, an innovative startup, or a global brand establishing in India, we help to create a certification path that fits your business objectives.
Have you decided to start the process toward BIS Certification for medical devices? Reach out to Diligence Certifications today
and get a free eligibility check + expert quote.
Frequently Asked Questions (FAQs)
Is BIS certification compulsory for all medical devices in India?
No, BIS certification is compulsory only for selected categories of electronic medical devices and diagnostic medical devices outlined in the CRS list. The Ministry of Health and BIS are actively working on adding to this list though. Therefore, it is wise to find out if your device is currently regulated or will be regulated. Diligence Certifications offers free product eligibility checks.
What is the difference between BIS and CDSCO certification?
CDSCO represents clinical safety and medical efficacy, whereas BIS represents technical and electrical safety regulations. Depending on the product, it may require one or both. For example, a blood pressure monitor would require CDSCO registration and BIS certification at the same time to legally sell the product in India.
Can startups apply for BIS certification for medical devices?
Yes, startups and MSMEs can apply. We help many first time applicants understand IS codes, submit applying documents and arrange for lab testing. Startups can even ask for our assistance developing a BIS compliant product design and manual.
How long is BIS certification valid?
Typically, BIS certification is valid for 2 years and can be renewed after re-evaluation. Renewal will request an updated compliance record and additionally, some sample retesting may be requested. We help clients with registration and renewal applications on time.
Is testing every batch of medical devices required?
No. Once certified, you can produce or import under that license number. However, the BIS may conduct random surveillance of your products post-certification or market check them to make sure you are still compliant.
How do I find out if a medical device is BIS certified?
Check to see if the BIS Standard Mark with the license number is packaged with the product, displayed, or on the device itself. Diligence Certifications guides our clients on proper label and mark use to avoid objections by the BIS.
What can happen if I sell a device without BIS certification?
Selling a device that is not BIS certified is a legal breach. The BIS may detain and destroy products, cancel BIS licenses, impose monetary penalties, or stop your imports. Diligence Certifications ensures complete compliance to avoid suppression actions
Can I export medical devices that are BIS certified?
Yes. BIS compliance is highly recognized in many countries especially in South Asia and the Middle East. Being BIS compliant is adds worth during international trading.
Will medical devices that I am importing need to be tested locally?
Yes. You will need to proceed with testing because for FMCS, samples need to be tested in a BIS-accredited lab in India even if tested in another country. Diligence Certifications will manage all logistics and communications for you.
How soon should I apply for BIS if I’m launching a new device?
Apply at least 90 days before your planned market launch. BIS certification involves testing, documentation, and possible audits. Early application avoids delays and ensures timely launch.
