This page covers the regulatory authority, device classification, registration process, local representative requirements and FAQs for medical device registration in India. Medical devices in India are regulated by the Central Drugs Standard Control Organization (CDSCO), and EVERBIZ can support you through the entire process from classification to registration.
1. Regulatory Framework
Medical devices in India are regulated by the Central Drugs Standard Control Organization (CDSCO), which sits under the Directorate General of Health Services (DGHS) of the Ministry of Health and Family Welfare.
Legal basis:
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Drugs and Cosmetics Act, 1940
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Medical Device Rules, 2017 (MDR 2017) – effective 1 January 2018, the core framework for medical device regulation in India
Submissions are made via the SUGAM online portal (cdscomdonline.gov.in). All documents must be in English.
2. Risk Classification
Under the First Schedule of MDR 2017, India uses a four-tier risk classification aligned with the EU MDR framework:
| Indian class | Risk | EU MDR equivalent | Licensing authority |
|---|---|---|---|
| Class A | Low | Class I | State Licensing Authority (SLA) |
| Class B | Low–moderate | Class IIa | State Licensing Authority (SLA) |
| Class C | Moderate–high | Class IIb | Central Licensing Authority (CLA) |
| Class D | High | Class III | Central Licensing Authority (CLA) |
Important update (23 October 2025): CDSCO issued a notice clarifying that the classification of all Class A and Class B devices must first be confirmed by the CLA; state authorities may not issue licenses without referring to the CDSCO classification list. Licenses found to have been issued in error must be revoked and corrected.
3. Prerequisites for Registration
1. Authorized Indian Agent: Foreign manufacturers must appoint a local agent (AIA) holding a valid Indian sales license or import license, who submits applications on the SUGAM portal and liaises with CDSCO. The Power of Attorney (POA) must be notarized or apostilled for India.
2. Manufacturer quality system: ISO 13485 certificate (manufacturing site).
3. Proof of approval in the country of origin: Approval from the country of origin or a GHTF country (US, EU, UK, Japan, Canada, Australia) – not mandatory, but helps speed up review.
4. Main License Types and Application Forms
| License | Application form | Purpose |
|---|---|---|
| MD-15 (import license) | Application on MD-14 | Import of foreign-made products into India |
| MD-5 (Class A/B manufacturing license) | Application on MD-3 | Domestic manufacturing of Class A/B in India |
| MD-9 (Class C/D manufacturing license) | Application on MD-7 | Domestic manufacturing of Class C/D in India |
| MD-10 (loan license) | Application on MD-8 | Contract manufacturing of Class C/D |
| MD-2 (Notified Body registration) | Application on MD-1 | Third-party audits of Class A/B manufacturers |
5. Registration Process (Import License Example)
Step 1 — Appoint an Authorized Indian Agent (AIA): The AIA must hold a valid import license (Form 10 or MD-15) or a wholesale license.
Step 2 — Determine the device class: Check the CDSCO classification database; if the device is not listed, from 27 November 2025 a classification request can be submitted through the new online mechanism (the IVD classification request system went live on 18 February 2026).
Step 3 — Prepare the Device Master File (DMF) and Plant Master File (PMF): The DMF contains the technical file, risk management, clinical evidence, etc. (it can be adapted from technical files for GHTF countries); the PMF describes the manufacturing site and quality system.
Step 4 — Submit the MD-14 application (SUGAM portal) with:
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POA (notarized)
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ISO 13485 certificate
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Free Sale Certificate (FSC) – issued by the competent authority of the country of origin
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DMF and PMF
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Draft labeling and IFU
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Clinical evidence / performance evaluation
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CE / FDA / TGA approvals (if any)
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Test reports
Step 5 — CDSCO review: Reviewers may issue queries, which must be answered on time.
Step 6 — Obtain the MD-15 import license
Step 7 — Obtain a customs NOC: Before import, a No Objection Certificate is issued by the ADC (Assistant Drugs Controller).
6. Registration Timelines and Validity
| Item | Time |
|---|---|
| Class A / B (SLA approval) | Relatively fast |
| Class C / D (CLA approval) | 6–9 months or longer |
| MD-15 import license | Usually 6–9 months |
MD-15 import license validity: perpetual (unless suspended or cancelled), with no renewal required – a major advantage of India compared with other Asia-Pacific markets. Manufacturing licenses (MD-5/MD-9): perpetual, with a retention fee payable every 5 years.
7. Special Requirements
1. Local IVD performance evaluation: New IVDs (Class B–D) must undergo clinical/performance evaluation in India regardless of approvals obtained abroad. This is a requirement specific to India.
2. Labeling
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Must include the name and address of the Authorized Indian Agent
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Must include the MD-15 license number
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Packaging levels, warnings and traceability information must comply with Chapter VIII of MDR 2017
3. Testing: Some products may need to be tested in local laboratories recognized by CDSCO.
8. Medical Device Software (SaMD/SiMD)
On 21 October 2025, CDSCO issued a draft guidance on medical device software:
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SiMD (embedded software) – inherits the risk class of the hardware it belongs to
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SaMD (standalone software) – classified independently according to intended use
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Risk management must comply with ISO 14971
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An Algorithm Change Protocol (ACP) must be submitted to manage AI/ML model changes
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Where several rules apply, the strictest classification applies
9. Post-Market Obligations
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PSUR (Periodic Safety Update Report) – submitted periodically according to risk class
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Adverse event reporting under the Materiovigilance Programme of India (MvPI)
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Field Safety Corrective Action (FSCA) notifications
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Market Standing Certificate (MSC) and Non-Conviction Certificate (NCC) – can now be generated automatically via SUGAM
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Change notifications – according to the Sixth Schedule of MDR 2017
10. Recent Key Changes
| Time | Change |
|---|---|
| April 2025 | CDSCO publishes MDR 2017 FAQ Addendum No. 01, clarifying many compliance details |
| 21 October 2025 | Draft guidance on medical device software issued, introducing SaMD/SiMD classification and the ACP mechanism |
| 23 October 2025 | CDSCO tightens Class A/B manufacturing licensing – SLAs must issue licenses according to the CLA classification list |
| 31 October 2025 | Official classification list for Class A (non-sterile, non-measuring) devices published |
| 27 November 2025 | Online mechanism for medical device classification requests launched |
| 18 February 2026 | Online mechanism for IVD classification requests launched |
Strategic Value and Challenges
Opportunities:
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One of the world’s largest medical device markets, driven by population and growing healthcare demand
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Import/manufacturing licenses are perpetual, keeping long-term compliance costs low
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Classification aligned with the EU MDR, so EU technical files can be largely reused
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The Make in India policy offers incentives for local production
Challenges:
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Relatively long CDSCO review times
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Mandatory local performance evaluation for IVDs
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The two-tier central/state licensing system creates compliance hurdles for Class A/B manufacturers
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The choice of AIA determines who holds the license – changing distributors may raise license transfer issues
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Strict labeling requirements (license number and AIA details must be shown)
How EVERBIZ Can Help
EVERBIZ has offices in Shanghai, Hong Kong, Germany, Austria, Singapore, Malaysia, Thailand and Vietnam. For the India market, we offer:
- Product classification and registration pathway planning
- Preparation and review of registration dossiers
- Local authorized representative / registration holder arrangements
- Submission, responses to deficiency letters and progress tracking
- Post-market compliance maintenance (changes, renewals, adverse event reporting)
Contact us for a India medical device registration plan and quote, or see our registration services for other countries and regions.
India Medical Device Registration FAQs
Which authority regulates medical devices in India?
The Central Drugs Standard Control Organization (CDSCO), under the Medical Devices Rules, 2017.
How can foreign manufacturers enter the Indian market?
They must appoint a local Authorized Agent in India and apply for an MD-15 import license through the SUGAM system.
How are medical devices classified in India?
By risk into Classes A, B, C and D; Class A/B and Class C/D are approved by licensing authorities at different levels.
How long is an Indian medical device import license valid?
The MD-15 import license is perpetual (unless suspended or cancelled) and does not need renewal, but a retention fee must be paid as required.