India BIS Certification for Medical Devices (2026): Complete Process, Applicable Standards, Costs, Timelines & CDSCO Relationship

Overview of BIS Certification for Medical Devices in India

India's medical device market is projected to reach $50 billion by 2030–2031, up from approximately $18 billion in 2026, making it one of the fastest-growing medtech markets globally. With approximately 70% of medical devices imported, India presents significant opportunities for foreign manufacturers — but market access requires navigating a dual regulatory system.

Two regulatory bodies govern medical device market entry in India:

1. CDSCO (Central Drugs Standard Control Organization) — handles regulatory and clinical licensing under the Medical Devices Rules (MDR) 2017
2. BIS (Bureau of Indian Standards) — handles product quality and safety certification under the BIS Act 2016

Many manufacturers assume that obtaining a CDSCO import license (Form MD-15) is sufficient. It is not. If your device falls under a notified Indian Standard (IS), BIS certification is also mandatory. Selling a device that requires BIS certification without it is illegal under Indian law.

This guide explains which devices require BIS certification, how the process works, costs, timelines, and how BIS certification relates to CDSCO approval.

What Is BIS Certification?

The Bureau of Indian Standards (BIS) is India's national standards body, established under the BIS Act 2016. BIS certification (also known as the ISI mark certification) verifies that products meet applicable Indian safety and quality standards before they can be sold or imported.

For medical devices, BIS certification primarily applies under:

• BIS Conformity Assessment Scheme-I (ISI Mark) — for products covered by mandatory Indian Standards
• Foreign Manufacturers Certification Scheme (FMCS) — for overseas manufacturers seeking the ISI mark

In 2026, BIS compliance is increasingly linked with CDSCO registration and government procurement eligibility. The two systems are complementary, not interchangeable.

BIS vs. CDSCO: What's the Difference?

Aspect	BIS Certification	CDSCO Approval
Focus	Product quality, safety, and performance standards	Regulatory and clinical control
Authority	Bureau of Indian Standards	Central Drugs Standard Control Organization
Governing Law	BIS Act 2016	Medical Devices Rules (MDR) 2017
Applies To	Products with notified IS standards	All medical devices (Class A–D)
Mandatory When	IS standard exists for the product type	Always required for import/manufacture
Output	ISI mark / BIS license number	Import/manufacturing license (Form MD-15)
Process	Product testing + factory audit + documentation review	Application via SUGAM portal + review

Key point: In many cases, both CDSCO approval and BIS certification are required for legal sale of a medical device in India.

Which Medical Devices Require BIS Certification?

BIS certification is mandatory for medical devices that fall under notified Indian Standards. The Bureau of Indian Standards has published over 1,700 healthcare-related standards, including more than 1,200 that directly apply to medical device categories.

Major Device Categories Under BIS Scope

By December 2025, 214 critical medical devices were brought under mandatory BIS certification scope. Key categories include:

Category	Examples of Devices	Applicable IS Standards
Medical electrical equipment	Patient monitors, ECG machines, defibrillators, ventilators	IS/IEC 60601 series
Diagnostic imaging	X-ray equipment, ultrasound systems, CT scanners	IS 7620 series, IS 12236
Surgical instruments	Scalpels, forceps, needle holders, retractors	IS 4140 series, IS 5405
Orthopedic implants	Bone plates, screws, joint replacements	IS/ISO 5835, IS/ISO 5836
Ophthalmic devices	Intraocular lenses, ophthalmoscopes	IS/ISO 11979 series
Dental devices	Dental amalgam, orthodontic brackets, dental cements	IS/ISO 24234, IS/ISO 27020
Cardiovascular devices	Heart valves, stents, cardiac prostheses	IS/ISO 5840 series
Sterilization equipment	Autoclaves, sterilization wraps	IS 7900, IS 8602
Patient safety	Thermometers, blood pressure monitors, syringes	IS 3574, IS 3611
Consumables	Sanitary napkins, baby diapers, surgical gloves	IS 5405, IS 13113

How to Check if Your Device Requires BIS

1. Visit the BIS website (bis.gov.in) and check the list of products under mandatory certification
2. Search the Manakonline portal for applicable IS standards
3. Check CDSCO's published list of standards forwarded from BIS (updated October 2025)
4. Cross-reference your device's product code against the notified IS numbers

If an IS standard exists for your device type and it is listed as mandatory, BIS certification is compulsory.

BIS Certification Schemes

Scheme-I: ISI Mark Certification (Indian Manufacturers)

For manufacturers with production facilities in India:

1. Application to BIS with required documentation
2. Factory inspection by BIS officers
3. Product samples drawn and tested at BIS-recognized laboratories
4. Grant of license to use the ISI mark

Foreign Manufacturers Certification Scheme (FMCS)

For overseas manufacturers without production facilities in India:

1. Application through BIS headquarters in New Delhi
2. Factory inspection by BIS officers (at manufacturer's overseas facility)
3. Product testing at BIS-recognized Indian laboratories
4. Appointment of an Authorized Indian Representative (AIR)
5. Grant of license to use the ISI mark for imported products

BIS Certification Process: Step-by-Step

Step 1: Identify Applicable BIS Standard

Determine which Indian Standard (IS) applies to your device. This involves:

• Identifying the device category and product code
• Searching the BIS standards database
• Checking if the standard is notified as mandatory

Step 2: Assess Factory Readiness

Ensure your manufacturing facility meets BIS requirements:

• Functional in-house testing laboratory
• Calibrated testing equipment with valid calibration certificates
• Qualified technical personnel
• Documented quality management system

Note: Under the updated BIS GoL Guidelines 2026 (issued February 26, 2026), the certification process now requires stronger documentation controls and fully functional in-house laboratories.

Step 3: Product Testing in BIS-Recognized Lab

Send product samples to a BIS-recognized laboratory for testing against the applicable IS standard. Testing covers:

• Electrical safety (for electronic devices)
• Electromagnetic compatibility (EMC)
• Biocompatibility (for devices contacting the body)
• Mechanical performance
• Environmental testing
• Software verification (for software-driven devices)

Step 4: Register on Manakonline Portal

Create an account on the Manakonline portal (BIS's digital platform) and submit:

• Device details
• Test reports
• Technical specifications
• Manufacturing process documentation

Step 5: Submit BIS Application

Submit the complete application package including:

• Application form (online via Manakonline)
• Test reports from BIS-recognized lab
• Factory layout and machinery list
• Quality manual
• Manufacturing process flow
• Authorized signatory documents

Step 6: Factory Inspection (If Applicable)

BIS officers conduct an on-site inspection of the manufacturing facility to verify:

• Production capability and consistency
• Quality control processes
• Testing equipment and calibration
• Compliance with the applicable standard

For foreign manufacturers under FMCS, BIS officers will inspect the overseas facility.

Step 7: Grant of BIS License

Upon satisfactory review of test results and factory inspection:

• BIS issues a license to use the ISI mark
• The license number must be displayed on the product and packaging
• The ISI mark can be applied to certified products

Documents Required

Document Category	Specific Documents
Product technical	Device description, technical specifications, intended use, model/variant details
Test reports	Test reports from BIS-recognized laboratory for each applicable IS standard
Manufacturing	Manufacturing process flow chart, factory layout, machinery list
Quality	Quality manual, in-house test procedures, calibration records
Regulatory	CDSCO registration (if already obtained), ISO 13485 certificate
Authorization	Authorized signatory documents, AIR appointment (for foreign manufacturers)
Application	Completed BIS application form, photographs of product and factory

Costs and Timelines

BIS Certification Costs (Estimated 2026)

Cost Component	Estimated Range
Application fee	INR 5,000–INR 10,000
Testing fees (BIS-recognized lab)	INR 50,000–INR 500,000+ per standard (varies by device complexity)
Factory inspection	INR 20,000–INR 50,000 (domestic); travel costs for foreign inspections
License fee	INR 5,000–INR 10,000 per year
Minimum Marking Fee (MMF)	Payable in two installments under 2026 guidelines: 50% at application, 50% at grant
Consultant fees (if engaged)	INR 100,000–INR 500,000
Total estimated cost	INR 200,000–INR 1,500,000+ ($2,400–$18,000) depending on device complexity and number of standards

Timeline

Stage	Duration
Standard identification and preparation	2–4 weeks
Sample testing at BIS lab	4–12 weeks (depends on test complexity)
Application submission and review	4–8 weeks
Factory inspection and follow-up	2–4 weeks
Grant of license	2–4 weeks
Total estimated timeline	4–8 months from start to ISI mark

Key 2026 Updates

BIS GoL Guidelines 2026 (Effective February 26, 2026)

The Bureau of Indian Standards issued updated Grant of Licence (GoL) Guidelines on February 26, 2026, introducing significant changes:

• Minimum Marking Fee (MMF): Now split into two installments — 50% payable at application stage and 50% at grant of license. A refund clause is defined in case of rejection or closure.
• Testing fee options: Two options available — testing fee borne by applicant, or verification sample testing cost subsumed within MMF.
• Stricter documentation controls: Fully functional in-house laboratories and calibrated testing equipment are now mandatory.
• Digital tracking: Improved digital tracking mechanisms throughout the certification process.
• Tighter timelines: Compliance deadlines are more strictly enforced.

CDSCO Risk Classification Updates (2025–2026)

CDSCO published new risk classification lists that interact with BIS requirements:

• Oncology device classification (January 2026)
• Radiotherapy devices (November 2025)
• Interventional radiology devices (November 2025)
• Class A (non-sterile, non-measuring) updated list (October 2025)

SUGAM Portal Modernization

The SUGAM portal was relaunched (April 9, 2025) as a fully automated platform. Key features:

• Auto-generated Market Standing Certificates (MSC)
• Auto-generated Non-Conviction Certificates (NCC)
• Digital-first certificate management

Draft Guidance on Medical Device Software

CDSCO published a draft guidance document on medical device software under MDR 2017 (October 2025), which may introduce additional BIS testing requirements for software-driven devices.

Relationship Between BIS and CDSCO

How They Work Together

1. BIS certification strengthens CDSCO submissions — BIS test reports and the ISI mark provide evidence of compliance with Indian standards during CDSCO review
2. Both may be required simultaneously — For devices with notified IS standards, you need both BIS certification and CDSCO registration
3. Government procurement — BIS certification is increasingly required for government tender eligibility
4. CDSCO references BIS standards — CDSCO's published standards lists are sourced from BIS

Recommended Sequencing

Approach	Sequence	Rationale
For devices with mandatory IS standards	BIS first → then CDSCO	BIS test reports support CDSCO application
For devices without mandatory IS standards	CDSCO only	BIS certification not required
For time-sensitive market entry	Parallel BIS + CDSCO	Start both simultaneously (requires careful coordination)

Common Challenges and Solutions

Challenge	Impact	Solution
Identifying the correct IS standard	Wrong standard = wasted testing time and cost	Cross-reference BIS database, CDSCO lists, and engage a local consultant
Incomplete documentation	Application delays of weeks or months	Use a comprehensive document checklist; engage experienced BIS consultants
Laboratory capacity constraints	BIS-recognized labs may have backlogs	Book testing slots early; consider multiple labs
Factory inspection failures	License denied; must reapply	Pre-audit the facility against BIS requirements before the official inspection
Confusion between BIS and CDSCO	Missing one certification = illegal sale	Map out requirements for your specific device category early in the planning process
Foreign manufacturer complexity	FMCS requires India-based representative and potential travel by BIS officers	Appoint a reliable Authorized Indian Representative early; budget for inspection logistics
2026 guideline changes	New MMF payment structure and documentation requirements	Review the updated BIS GoL Guidelines 2026 before submitting

Practical Strategy for Foreign Manufacturers

Step-by-Step Market Entry Plan

1. Month 1–2: Identify applicable IS standards and CDSCO classification; engage an Authorized Indian Representative
2. Month 2–4: Prepare documentation; send samples to BIS-recognized lab for testing
3. Month 3–5: Submit BIS application via Manakonline; prepare CDSCO application via SUGAM
4. Month 4–6: BIS factory inspection; respond to any CDSCO queries
5. Month 6–8: Receive BIS license (ISI mark); obtain CDSCO import license (Form MD-15)
6. Month 8+: Begin importing and selling in India

Key Partners You Need

• Authorized Indian Representative (AIR) — Required for FMCS; acts as liaison with BIS
• Indian Authorized Agent (IAA) — Required for CDSCO import license; cannot apply without one
• BIS-recognized testing laboratory — Must be on BIS's approved list for the specific standard
• Local regulatory consultant — Strongly recommended for navigating both BIS and CDSCO simultaneously

FAQ

Is BIS certification mandatory for all medical devices in India?

No. BIS certification is mandatory only for devices covered by a notified Indian Standard (IS). However, CDSCO registration is mandatory for all medical devices (Class A–D) as of 2026. If your device has a notified IS standard, you need both.

How is BIS certification different from ISO 13485?

ISO 13485 is a quality management system standard that covers your entire manufacturing process. BIS certification is product-specific — it verifies that a particular device meets the applicable Indian Standard. They are complementary; having ISO 13485 may facilitate BIS certification but does not replace it.

Can I use test reports from international labs for BIS certification?

Generally, BIS requires testing at BIS-recognized laboratories. Some international test reports (e.g., IEC 60601-series electrical safety tests) may be accepted as supporting documentation, but confirm with BIS before relying on them.

How long is a BIS license valid?

BIS licenses are typically valid for 1–2 years and must be renewed. The renewal process involves a fresh factory inspection and may require re-testing of product samples.

What happens if I sell a device without BIS certification when it's required?

Selling a non-certified device that requires BIS certification is a violation of the BIS Act 2016. Consequences include product seizure, fines, and potential imprisonment. The device is treated as non-compliant and illegal.

Does the ISI mark apply to all product packaging?

Yes. Once certified, the ISI mark (including the BIS license number) must be displayed on the product and its packaging. The specific marking requirements are detailed in the applicable IS standard and the BIS license terms.

Key Takeaways

• BIS certification is separate from and additional to CDSCO registration — both may be required for your device
• 214 critical medical devices are now under mandatory BIS certification scope (as of December 2025)
• BIS GoL Guidelines 2026 introduce stricter documentation, new fee payment structures, and digital tracking
• Start early — the BIS process takes 4–8 months and should run in parallel with CDSCO registration
• Testing at BIS-recognized labs is mandatory — international lab reports are generally not sufficient
• The Manakonline portal is the central digital platform for all BIS submissions
• Foreign manufacturers need an Authorized Indian Representative for the FMCS pathway