India’s Trusted BIS Consultants — 2026
BIS Certification Services in India for Medical Devices & Products
Quick Answer: BIS stands for the Bureau of Indian Standards — India’s national body that checks whether products are safe and of good quality. BIS certification means your product has been tested and approved to meet Indian safety standards. For medical devices, this is now mandatory under India’s rules, and you cannot sell or import them without it.
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What is BIS Certification? (Simple Explanation for Everyone)
BIS full form is Bureau of Indian Standards. It is a government body under the Ministry of Consumer Affairs. When a product gets BIS certification, it means that the product has passed safety and quality tests as per Indian Standards. For medical devices, the BIS Standard ensures that devices used on patients are safe, effective, and meet global-level quality benchmarks. Without BIS certification, your medical device cannot legally be sold in India.
About BIS
Bureau of Indian Standards — India's Quality Backbone
BIS was established in 1986 under the BIS Act and operates from New Delhi. It sets quality standards for thousands of products sold in India, from electronics to food to medical equipment. In 2026, BIS has become even more critical as India tightens regulations on imported and domestically manufactured medical devices.
- BIS operates under the Ministry of Consumer Affairs, Food & Public Distribution
- Governs the IS (Indian Standard) mark used on certified products
- Works with CDSCO for medical device regulation compliance
- Has over 22,000 Indian Standards across industries
- Foreign manufacturers need an Indian Authorized Representative (IAR)
- Product testing at BIS-recognized labs is mandatory
BIS Certification — Key Facts 2026
| Parameter | Details |
|---|---|
| BIS Full Form | Bureau of Indian Standards |
| Governing Act | BIS Act, 2016 |
| Certificate Validity | 1–2 years (renewable) |
| Mark on Product | ISI Mark / IS Mark |
| Mandatory for MD? | Yes (selected devices) |
| Foreign Mfr. Need? | Indian Authorized Representative |
| Timeline | 30–90 days (with consultant) |
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Why It Matters
Why BIS Certification for Medical Devices is Critical in 2026
India’s medical device market is expected to reach $50 billion by 2030. BIS compliance is not just a legal box — it’s your market entry key.
Legal Mandate
Many medical devices in India now fall under mandatory BIS certification. Selling without it can result in fines, seizures, and business shutdown.
Patient Safety First
BIS standards ensure that devices used in hospitals and clinics meet rigorous safety and performance criteria, protecting both patients and healthcare providers.
Market Access
BIS certification opens doors to government tenders, hospital procurement, and export markets by proving your product meets India's top quality benchmarks.
Brand Protection
Certified products cannot be easily copied or sold as counterfeits. The ISI mark is a powerful trust signal that consumers and hospitals actively look for.
Competitive Advantage
Companies with BIS certification win more contracts, command better pricing, and enjoy stronger buyer trust than non-certified competitors in the market.
Align with Global Standards
Indian BIS standards for medical devices are harmonized with ISO 13485 and IEC standards, making it easier to get international regulatory approvals as well.
BIS Standard for Medical Devices
Key BIS Standards for Medical Devices in India
India follows Indian Standards (IS) numbers for different categories of medical devices. Here are the most important ones in 2026:
| Device Category | IS Standard Number | Equivalent International Standard | Mandatory? |
|---|---|---|---|
| Surgical Instruments | IS 7194 | ISO 7153 | Yes |
| Syringes & Needles | IS 10258 | ISO 7886 | Yes |
| Catheters | IS 12476 | ISO 10555 | Yes |
| Blood Pressure Monitors | IS 16649 | IEC 80601-2-30 | Yes |
| Pulse Oximeters | IS 16473 | ISO 80601-2-61 | Yes |
| Diagnostic Ultrasound | IS 15869 | IEC 60601-2-37 | Yes |
| Hearing Aids | IS 16023 | IEC 60118 | Yes |
| Glucometers | IS 16294 | ISO 15197 | Yes |
| Ventilators | IS 17897 | ISO 80601-2-12 | Yes |
| PPE / Protective Masks | IS 9473 | EN 149 | Yes |
Note: This list is updated as of 2026. New device categories are added regularly by BIS. Consult our experts for the latest list.
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Step-by-Step
BIS Certification Process for Medical Devices — 2026
Our certified BIS consultants guide you through every step. No paperwork confusion, no delays.
Device Classification & Eligibility Check
Identify the correct IS standard for your device and confirm whether BIS certification is mandatory or voluntary for your product category.
⏱ 1–2 Days
Document Preparation
Compile all required documents including technical file, manufacturing details, test reports, and company incorporation proof.
⏱ 3–7 Days
Online Application on BIS Portal
Submit the application on manakonline.in, the official BIS portal. Our team fills every field correctly to avoid rejections.
⏱ 1–2 Days
Product Testing at BIS Lab
Samples are tested at BIS-recognized laboratories against the relevant IS standard. We coordinate sample collection and submission.
⏱ 15–30 Days
Factory / Facility Inspection
For domestic manufacturers, a BIS officer visits the factory to verify quality processes. We help you prepare for the audit.
⏱ 5–10 Days
BIS License Grant & Marking
Once approved, you receive your BIS license number and can apply the ISI mark on your products. We provide post-certification support.
⏱ 7–14 Days
Total Timeline Overview
| Stage | Time |
|---|---|
| Preparation | 7–14 days |
| Application | 1–3 days |
| Lab Testing | 15–30 days |
| Factory Audit | 5–10 days |
| Grant of License | 7–14 days |
| Total (with consultant) | 30–60 days |
| Without consultant | 90–180 days |
With Tracc Global, most clients receive BIS certification in 45–60 days — 2× faster than the industry average.
Documentation
Documents Required for BIS Certification for Medical Devices
Missing even one document causes delays. Here’s the complete checklist for 2026:
Company & Legal Documents
- Certificate of Incorporation / MOA / AOA
- GST Registration Certificate
- PAN Card of Company
- Authorized Signatory Letter
- Factory Registration / Shop Act License
- MSME / Udyam Registration (if applicable)
Technical & Product Documents
- Technical File / Device Master Record
- Product Specifications & Drawings
- List of Raw Materials with Sources
- In-Process & Finished Goods QC Reports
- User Manual / Instructions for Use (IFU)
- Labelling Details & Packaging Samples
Manufacturing / Facility Documents
- Factory Layout Plan (detailed)
- List of Manufacturing Equipment
- Calibration Records of Test Equipment
- Quality Control Process Flow Chart
- CDSCO License (if already obtained)
Additional — Foreign Manufacturers
- Appointment Letter for Indian Authorized Representative (IAR)
- Notarized Power of Attorney (India Consulate attested)
- Country of Origin Certificate
- CE Mark / ISO 13485 Certificate (supporting)
- Free Sale Certificate from country of origin
Fees & Costs
BIS Certification Fees for Medical Devices — 2026 Guide
BIS certification involves multiple fee components. Here’s a transparent breakdown:
| Fee Component | Domestic Manufacturer | Foreign Manufacturer | Notes |
|---|---|---|---|
| Application Fee (BIS Portal) | ₹1,000 – ₹5,000 | ₹10,000 – ₹25,000 | Non-refundable |
| Testing / Lab Charges | ₹15,000 – ₹80,000 | ₹30,000 – ₹1,50,000 | Varies by device complexity |
| Factory Inspection Fee | ₹5,000 – ₹20,000 | ₹50,000 – ₹2,00,000 | Includes BIS officer travel |
| Annual Marking Fee | ₹5,000 – ₹50,000 | ₹10,000 – ₹1,00,000 | Depends on production volume |
| Consultant Fee (Tracc Global) | Contact for Custom Quote | Saves 3–6 months & reduces rejection risk | |
⚠ Fees are subject to change by BIS. Always confirm current fees on the official BIS portal (bis.gov.in) or consult our team.
Smart Decision
Self-Application vs. Hiring BIS Certification Consultants
Should you do it yourself or hire experts? Here’s an honest, data-backed comparison:
Self-Application (DIY)
- Certificate of Incorporation / MOA / AOA
- High risk of application rejection (60%+ first-timers fail)
- No expert to guide on correct IS standard
- Risk of incorrect lab selection → wasted testing fees
- Factory audit failures are common without preparation
- Full team bandwidth consumed in compliance work
- Saves consultant fee (but loses time & money on errors)
With BIS Certification Consultants
- Average timeline: 30–60 days
- 98% first-attempt success rate (Tracc Global)
- Correct IS standard identified within 24 hours
- Relationship with BIS-approved labs for faster testing
- Pre-audit factory preparation included
- Your team focuses on business, not paperwork
- Post-certification renewal & surveillance support
Ready to skip the confusion and get certified fast?
Tracc Global — India's Most Trusted BIS Certification Consultants since 2010
Real Success Story
Client Case Study — E-E-A-T Proof
Real Case Study — 2025
How a Delhi-Based Medical Device Startup Got BIS Certified in 42 Days
Client: A Delhi-based startup manufacturing non-invasive blood pressure monitors. They had been trying to get BIS certification for 8 months on their own — facing repeated rejections, lab test failures, and audit non-compliances. Their product launch was delayed by almost a year.
Challenge: Wrong IS standard selected (IS 16649 instead of IS 16473), incorrect lab chosen, and factory layout not compliant with BIS audit requirements. They had already lost over ₹3.5 lakhs in wasted fees.
Solution: They engaged Tracc Global. Our team corrected the IS standard selection within 24 hours, arranged testing at the right BIS-recognized lab, prepared a full compliance checklist for the factory audit, and submitted a clean application on the BIS portal.
Result: BIS certification granted in 42 days. The client launched their product across 3 major hospital chains within 60 days of certification. Revenue in the first quarter post-launch: ₹78 lakhs.
42
Days to Certification
₹3.5L
Previous Losses Avoided
₹78L
Q1 Revenue Post-Launch
Avoid These Errors
8 Common BIS Certification Mistakes That Cause Delays & Rejections
These are the most expensive mistakes we see companies make every year:
Wrong IS Standard Selected
Choosing an incorrect Indian Standard is the #1 reason for application rejection. Always verify with a BIS expert before applying.
Incomplete Technical File
Missing device specifications, drawings, or QC records causes BIS to put your application on hold indefinitely.
Non-BIS Recognized Lab Used
Testing at a lab not recognized by BIS means your test reports are invalid and you have to repeat testing — wasting time and money.
Factory Not Ready for Audit
A factory that hasn't been prepared for a BIS inspection will fail. Equipment calibration, layout, and SOPs must all be audit-ready.
Incorrect Product Labelling
Product labels must conform to the applicable IS standard's marking requirements. Non-compliance is a common rejection reason.
Foreign Mfr. Without Proper IAR
Foreign manufacturers applying without a properly appointed Indian Authorized Representative will have their application rejected outright.
Ignoring Renewal Deadlines
BIS licenses expire. Selling certified products after license expiry is illegal and can result in penalty action by BIS enforcement.
Not Updating BIS on Changes
Any change in product design, raw materials, or manufacturing process must be communicated to BIS. Failing to do so voids your certification.
Pro Tips
Expert Tips to Speed Up Your BIS Certification
15 years of BIS consulting experience distilled into actionable tips:
Wrong IS Standard Selected
Choosing an incorrect Indian Standard is the #1 reason for application rejection. Always verify with a BIS expert before applying.
Build a Pre-Audit Checklist
Prepare your factory for the BIS inspection at least 30 days before the audit. Document everything — BIS officers love paper trails.
Choose the Right Test Lab First
Not all labs test all devices. Confirm that your chosen lab is BIS-approved for your specific device category before sending samples.
Keep Documents in One Folder
Create a BIS Documentation Master Folder. Any missing document during review adds 2–4 weeks to your timeline.
Apply During Non-Peak Periods
BIS application processing is faster between January–March and August–September. Avoid applying in December or during festive months.
Hire Consultants Early
Companies that engage BIS certification consultants at the start of the process (not after a rejection) save an average of 3–4 months.
People Also Ask
Frequently Asked Questions — BIS Certification for Medical Devices
These are the most searched questions on Google about BIS certification:
What is BIS full form in medical device context?
BIS full form is Bureau of Indian Standards. In the context of medical devices, BIS is the regulatory body that sets Indian Standards (IS) for the safety, performance, and quality of medical equipment sold or manufactured in India. BIS certification for medical devices ensures that the product has been tested and found to comply with the relevant Indian Standard, making it legally eligible for sale in the Indian market.
Is BIS certification mandatory for all medical devices in India?
No, BIS certification is not yet mandatory for all medical devices in India. However, India has been steadily expanding the list of devices that require mandatory BIS certification. As of 2026, devices like blood pressure monitors, pulse oximeters, syringes, catheters, diagnostic ultrasound equipment, glucometers, hearing aids, and personal protective equipment (PPE) require mandatory BIS certification. The government issues notifications through the QCO (Quality Control Order) mechanism to bring new devices under mandatory BIS requirements. It is advisable to check the latest QCOs or consult a BIS expert to confirm the status for your specific device.
How long does BIS certification for medical devices take in India?
The timeline for BIS certification for medical devices in India typically ranges from 30 to 90 days when working with an experienced BIS consultant. Without professional help, the process can take 6 to 18 months due to document errors, incorrect lab selection, and audit non-compliances. The major time-consuming steps are product testing (15–30 days) and factory inspection scheduling. At Tracc Global, most of our medical device clients receive BIS certification within 42–60 days on average.
What is the difference between BIS certification and CDSCO registration for medical devices?
BIS certification and CDSCO registration are two separate regulatory requirements for medical devices in India. CDSCO (Central Drugs Standard Control Organisation) registration is required under the Medical Devices Rules, 2017, and focuses on the safety, efficacy, and clinical performance of the device — it is mandatory for all classified medical devices (Class A, B, C, D). BIS certification, on the other hand, is administered by the Bureau of Indian Standards and focuses on whether the product meets the relevant Indian Standard (IS) for quality and safety specifications. For many devices, you will need both: CDSCO registration AND BIS certification. Always verify which regulatory approvals apply to your specific device.
What is the cost of BIS certification for medical devices?
The total cost of BIS certification for medical devices in India includes several components: BIS portal application fee (₹1,000–₹25,000 depending on manufacturer type), product testing charges at a BIS-recognized lab (₹15,000–₹1,50,000 depending on device complexity), factory inspection fee (₹5,000–₹2,00,000 for foreign manufacturers), and annual marking fee based on production volume. Additionally, if you engage a BIS certification consultant, there will be a professional service fee. The overall cost for a domestic manufacturer typically ranges from ₹50,000 to ₹3,00,000, while foreign manufacturers may spend more due to travel and inspection costs.
Can a foreign medical device manufacturer get BIS certification in India?
Yes, foreign medical device manufacturers can obtain BIS certification in India, but they must appoint an Indian Authorized Representative (IAR) to manage the certification process in India on their behalf. The IAR must be a registered entity in India. Foreign manufacturers also face additional requirements such as a notarized Power of Attorney, a Country of Origin Certificate, and a Free Sale Certificate from their home country. BIS may also conduct an overseas factory inspection, which adds to the cost and timeline. Working with a professional BIS consultant who has experience with foreign manufacturer applications is strongly recommended to avoid common pitfalls.
What happens if I sell a medical device in India without BIS certification?
Selling a medical device in India that is covered under a mandatory BIS Quality Control Order (QCO) without having valid BIS certification is illegal and can result in serious consequences. These include: product seizure and destruction by BIS enforcement authorities, heavy financial penalties, criminal prosecution under the BIS Act 2016, import consignment detention at customs ports, and permanent damage to your brand reputation. The penalties under the BIS Act 2016 can include imprisonment of up to 2 years and/or fines up to ₹2 lakhs for first-time offenders, with higher penalties for repeat violations.
What is the validity of BIS certification for medical devices?
BIS certification (license) for medical devices is typically valid for 1 year initially and can be renewed annually. BIS conducts surveillance testing and periodic inspections during the validity period to ensure continued compliance. It is critical to track your BIS license expiry date and apply for renewal well in advance (at least 60 days before expiry). Selling products under an expired BIS license is treated the same as selling without certification. Our team at Tracc Global provides renewal tracking and reminder services for all certified clients.
Which laboratories are recognized by BIS for medical device testing in India?
BIS maintains an official list of recognized (NABL-accredited) laboratories for testing different categories of medical devices against Indian Standards. These labs are listed on the official BIS website (bis.gov.in). The recognition is device and IS standard specific — meaning a lab recognized for testing surgical instruments may not be recognized for testing ECG machines. Using a lab that is not BIS-recognized for your specific device will result in invalid test reports and cause significant delays. Our BIS consultants maintain updated relationships with recognized labs and coordinate the sample submission process on your behalf.
How do I apply for BIS certification online in India?
BIS certification applications are submitted through the official BIS Manak Online portal at manakonline.in. The steps include: creating an account on the portal, selecting the correct product scheme (ISI Mark Scheme for most manufactured goods), uploading all required documents in the specified format, paying the application fee online, selecting a BIS-recognized test laboratory, and scheduling the factory inspection. The portal also allows you to track the status of your application. However, navigating the portal and correctly filling in all details without errors requires familiarity with BIS processes. First-time applicants are strongly advised to work with a certified BIS consultant to avoid rejection.
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