- CDSCO Registration Required: All oxygen concentrators — domestic or imported — must be registered under MDR 2017 before entering the Indian market.
- Class-Based Licensing: Risk classification (Class A, B, C, D) determines your application form — MD-3/5 for manufacturers, MD-14/15 for importers, MD-41/42 for wholesale.
- SUGAM Portal Process: All CDSCO medical device license applications are filed digitally via the SUGAM online portal — no physical submissions required.
- 2026 Regulatory Update: CDSCO has tightened QMS and performance standard requirements; non-compliant concentrators face market withdrawal under the MDR 2017 enforcement drive.
Introduction
An oxygen concentrator is a Class B medical device under MDR 2017, requiring CDSCO registration before manufacture, import, or sale in India. Manufacturers need Form MD-3 (application) and MD-5 (license) for Class A/B devices. Importers apply via MD-14 and receive MD-15.
Wholesale distributors use MD-41 and receive MD-42. All applications are filed on the SUGAM portal. Regulatory compliance under the Medical Devices Rules, 2017 is mandatory for all oxygen concentrators sold in India as of 2024–2026.
What Is a CDSCO License for an Oxygen Concentrator?
An oxygen concentrator is a life-supporting medical device that separates oxygen from ambient air and delivers it to patients with respiratory conditions, including COPD, pneumonia, and COVID-19-related hypoxia. In India, oxygen concentrators are regulated as medical devices under the Medical Devices Rules (MDR) 2017 notified under the Drugs and Cosmetics Act, 1940, and the Central Drugs Standard Control Organization (CDSCO) is the apex authority overseeing their registration, import, manufacture, and distribution.
Any company — whether a domestic manufacturer, foreign manufacturer, authorized Indian agent, or wholesale distributor — must obtain the appropriate CDSCO license for oxygen concentrator before undertaking any commercial activity in India. This guide explains every aspect of the licensing process, applicable forms, fee structures, timelines, and compliance requirements as updated through 2026.
Oxygen Concentrator Risk Classification Under MDR 2017
CDSCO classifies medical devices into four risk categories — Class A (lowest risk) to Class D (highest risk) — based on intended use, duration of contact with the body, and potential patient harm. Oxygen concentrators currently fall under Class B of MDR 2017, meaning they are moderately low-risk devices with non-invasive patient contact for short to medium duration.
| Class | Risk Level | License Forms | Regulatory Body | Oxygen Concentrator? |
| Class A | Low Risk | MD-3 / MD-5 | State Licensing Authority | ✗ Not Applicable |
| Class B | Moderate Low Risk | MD-3 / MD-5 | CDSCO (Central) | ✔ Oxygen Concentrator |
| Class C | Moderate High Risk | MD-7 / MD-9 | CDSCO (Central) | ✗ Not Applicable |
| Class D | High Risk | MD-7 / MD-9 | CDSCO (Central) | ✗ Not Applicable |
Important: All portable and stationary oxygen concentrators intended for home or clinical use are classified as Class B medical devices under Schedule I of MDR 2017. Any concentrator with invasive delivery mechanism may attract a higher class — verify with CDSCO before applying.
Oxygen Concentrator Products Classified Under MDR 2017
The following oxygen concentrator types and related products are recognized under the CDSCO medical device classification. The majority fall under Class B. Refer to the table below for the product-wise classification:
| CLASS B — Moderate Low-Risk Oxygen Concentrators (CDSCO Central License) | |||
| S.No. | Product Name | Device Category | Applicable License Forms |
| 1 | Oxygen Concentrator (Stationary) | Life Support / Therapeutic | MD-3/MD-5 (Mfg) | MD-14/MD-15 (Import) | MD-41/MD-42 (Wholesale) |
| 2 | Portable Oxygen Concentrator | Life Support / Therapeutic | MD-3/MD-5 (Mfg) | MD-14/MD-15 (Import) | MD-41/MD-42 (Wholesale) |
| 3 | Pulse Dose Oxygen Concentrator | Therapeutic Device | MD-3/MD-5 (Mfg) | MD-14/MD-15 (Import) | MD-41/MD-42 (Wholesale) |
| 4 | Continuous Flow Oxygen Concentrator | Therapeutic Device | MD-3/MD-5 (Mfg) | MD-14/MD-15 (Import) | MD-41/MD-42 (Wholesale) |
| 5 | Home Oxygen Concentrator | Home Use Therapeutic | MD-3/MD-5 (Mfg) | MD-14/MD-15 (Import) | MD-41/MD-42 (Wholesale) |
| 6 | Clinical / Hospital Oxygen Concentrator | Clinical Therapeutic | MD-3/MD-5 (Mfg) | MD-14/MD-15 (Import) | MD-41/MD-42 (Wholesale) |
| 7 | Neonatal Oxygen Concentrator | Paediatric Life Support | MD-3/MD-5 (Mfg) | MD-14/MD-15 (Import) | MD-41/MD-42 (Wholesale) |
| 8 | High Flow Oxygen Concentrator (up to 10 LPM) | Respiratory Therapy | MD-3/MD-5 (Mfg) | MD-14/MD-15 (Import) | MD-41/MD-42 (Wholesale) |
| 9 | Dual Flow Oxygen Concentrator | Respiratory Therapy | MD-3/MD-5 (Mfg) | MD-14/MD-15 (Import) | MD-41/MD-42 (Wholesale) |
| 10 | Travel / Aviation Oxygen Concentrator | Portable Life Support | MD-3/MD-5 (Mfg) | MD-14/MD-15 (Import) | MD-41/MD-42 (Wholesale) |
Note: Class A devices are handled by State Licensing Authorities (SLAs) and typically include very low-risk accessories. Class C and Class D classifications apply to implantable, high-risk, or active implantable devices and are not applicable to standard oxygen concentrators. However, oxygen delivery systems integrated with invasive respiratory support (e.g., mechanical ventilators) may attract Class C/D classification — always confirm with CDSCO before filing.
All CDSCO License Forms for Oxygen Concentrators — At a Glance
| Form | Purpose | Applicant Type | Device Class | Issued By | Output License |
| MD-3 | Application for Manufacture License | Domestic Manufacturer | Class A / B | CDSCO / SLA | MD-5 |
| MD-5 | Grant of Manufacture License | Domestic Manufacturer | Class A / B | CDSCO / SLA | Final License |
| MD-7 | Application for Manufacture License | Domestic Manufacturer | Class C / D | CDSCO Central | MD-9 |
| MD-9 | Grant of Manufacture License | Domestic Manufacturer | Class C / D | CDSCO Central | Final License |
| MD-14 | Application for Import License | Authorized Indian Agent / Importer | All Classes | CDSCO Central | MD-15 |
| MD-15 | Grant of Import License | Authorized Indian Agent / Importer | All Classes | CDSCO Central | Final License |
| MD-41 | Application for Wholesale License | Wholesale Distributor | All Classes | State Licensing Authority | MD-42 |
| MD-42 | Grant of Wholesale License | Wholesale Distributor | All Classes | State Licensing Authority | Final License |
Manufacturing License for Class A & B: MD-3 Application and MD-5 Grant of License
If your company manufactures oxygen concentrators in India under Class A or Class B, you must apply through Form MD-3 and receive Form MD-5 as the grant of license. Class A devices are regulated by the State Licensing Authority; Class B devices — which include all standard oxygen concentrators — are regulated by the CDSCO Central Licensing Authority (CLA).
What Is MD-3? (Application for Manufacturing License — Class A/B)
MD-3 is the formal application form under MDR 2017, Schedule I, Part I. It is submitted by domestic manufacturers seeking a license to manufacture Class A or Class B medical devices at a specified premises in India. The MD-3 application captures details such as device name, risk class, manufacturing site address, quality management system certification, and technical documentation.
What Is MD-5? (Grant of Manufacturing License — Class A/B)
MD-5 is the manufacturing license certificate issued by CDSCO (for Class B) or the SLA (for Class A) upon successful review of the MD-3 application. It authorizes the holder to manufacture the specified device(s) at the approved premises and is the legal proof of manufacturing permission in India.
Eligibility for MD-3 / MD-5 Manufacturing License
- Registered Indian entity: Must be a company or firm registered in India (Pvt Ltd, LLP, or Proprietorship).
- Manufacturing premises: Dedicated, GMP-compliant production facility within India.
- QMS certification: ISO 13485:2016 quality management system certification is mandatory for Class B devices.
- Qualified personnel: Designated responsible technical person (RTP) with requisite qualifications.
- Device approval: Either a valid CDSCO device registration or type approval for the oxygen concentrator model(s) to be manufactured.
Documents Required for MD-3 Application (Oxygen Concentrator Manufacturing)
| S.No. | Document | Notes |
| 1 | Completed Form MD-3 | Signed by authorized signatory |
| 2 | Certificate of Incorporation / Partnership Deed / GST Registration | Proof of legal entity |
| 3 | ISO 13485:2016 Certificate | Valid and covering oxygen concentrator |
| 4 | Site Master File / GMP Compliance Certificate | Manufacturing premises details |
| 5 | Technical Documentation / Design Dossier | IEC 80601-2-69 compliance preferred |
| 6 | Biocompatibility / Safety & Performance Test Reports | From NABL/accredited lab |
| 7 | List of Equipment / Instruments in Manufacturing Unit | Calibrated and validated |
| 8 | Qualified Person Details (RTP) | Educational certificates + experience proof |
| 9 | Layout Plan of Manufacturing Premises | Dimension-wise floor plan |
| 10 | Declaration of Conformity | Self-declaration on safety & performance |
| 11 | Undertaking as per MDR 2017 | Compliance undertaking on prescribed format |
| 12 | Challan / Fee Payment Receipt | Paid via SUGAM portal |
MD-3 / MD-5 Fee Structure (2026)
| Application Type | Device Class | Govt. Fee (₹) | Per Additional Device (₹) |
| MD-3 (New Manufacturing License) | Class A | 2,500 | 500 |
| MD-3 (New Manufacturing License) | Class B | 5,000 | 1,000 |
| MD-3 Amendment / Variation | Class A/B | 2,500 | — |
| MD-5 Renewal | Class A/B | 5,000 | 1,000 |
Manufacturing License for Class C & D: MD-7 Application and MD-9 Grant of License
For completeness, manufacturers of high-risk Class C and Class D medical devices apply via Form MD-7 and receive Form MD-9 as the grant of license from CDSCO Central. While standard oxygen concentrators are Class B, some advanced oxygen therapy systems integrated with invasive respiratory support or active implantable components may warrant a Class C or D classification.
What Is MD-7? (Application for Manufacturing License — Class C/D)
MD-7 is the prescribed application form under MDR 2017 for manufacturers seeking a license to produce Class C (moderate-high risk) or Class D (high risk) devices. The documentation and audit requirements for MD-7 are more stringent than MD-3, including mandatory clinical data, performance evaluation reports, and a pre-market inspection by CDSCO officers before the license is granted.
What Is MD-9? (Grant of Manufacturing License — Class C/D)
MD-9 is the manufacturing license certificate issued by CDSCO Central after successful evaluation of the MD-7 application. It is the highest-tier manufacturing authorization under MDR 2017 and carries more rigorous post-market obligations including periodic CDSCO inspections and adverse event reporting.
| Criterion | MD-3 / MD-5 (Class A/B) | MD-7 / MD-9 (Class C/D) |
| Target Devices | Class A, Class B (incl. Oxygen Concentrators) | Class C, Class D (High-risk devices) |
| Licensing Authority | SLA (Class A) / CDSCO (Class B) | CDSCO Central only |
| QMS Requirement | ISO 13485 mandatory for Class B | ISO 13485 + clinical data + CDSCO audit |
| Government Fee (New) | ₹5,000 (Class B) | ₹50,000 (Class C/D) |
| Pre-license Inspection | May be waived for Class B | Mandatory site inspection by CDSCO |
| Processing Time | 45–90 working days | 90–180 working days |
Import License for Oxygen Concentrator: MD-14 Application and MD-15 Grant of License
If you are importing oxygen concentrators from an overseas manufacturer into India, you must obtain an Import License (Form MD-15) by filing Form MD-14 with CDSCO Central. The Authorized Indian Agent (AIA) of the foreign manufacturer or the Indian importer is the applicant. Without a valid MD-15, no oxygen concentrator can legally be imported, sold, or distributed in India.
What Is MD-14? (Application for Import License)
MD-14 is the official application form prescribed under MDR 2017 for entities seeking a license to import medical devices including oxygen concentrators. It must be submitted via the SUGAM portal along with the complete technical dossier, foreign manufacturer approvals, AIA agreement, and device registration details.
What Is MD-15? (Grant of Import License)
MD-15 is the Import License granted by the Central Licensing Authority (CLA) of CDSCO after review and approval of the MD-14 application. The MD-15 is device-specific and manufacturer-specific — a separate MD-15 is required for each unique oxygen concentrator model from each foreign manufacturer. The MD-15 import license is valid for 3 years and is renewable.
Eligibility for MD-14 / MD-15 Import License
- Indian Legal Entity: Must be a company or firm registered in India — Pvt Ltd, LLP, OPC, or Partnership.
- Authorized Indian Agent Agreement: Valid AIA agreement with the foreign manufacturer authorizing the Indian entity to import and sell the device.
- Foreign Manufacturer Approval: The overseas manufacturer must hold valid manufacturing authorization from their own country's regulatory authority (e.g., FDA 510k, CE Mark, TGA).
- Free Sale Certificate: Certificate confirming the device is freely sold in the country of manufacture or another reference market.
- CDSCO Registration or Exemption: The device must either hold a valid CDSCO registration number or the application must include a registration request simultaneously.
Documents Required for MD-14 Application (Oxygen Concentrator Import)
| S.No. | Document | Remarks |
| 1 | Completed Form MD-14 | Digitally signed on SUGAM portal |
| 2 | Authorized Indian Agent (AIA) Agreement | Notarized, valid and in English |
| 3 | Free Sale Certificate (FSC) | Apostilled from country of origin |
| 4 | ISO 13485 Certificate of Foreign Manufacturer | Covering oxygen concentrator manufacture |
| 5 | Technical Documentation / Performance Testing Reports | As per IEC 80601-2-69 or equivalent |
| 6 | Home Country Regulatory Approval (FDA / CE / TGA / PMDA) | Copy of approval certificate |
| 7 | Declaration of Conformity | Signed by foreign manufacturer |
| 8 | 510k / CE Technical File Summary (if available) | Expedites CDSCO review |
| 9 | Label and Labelling Artwork | Must include required MDR 2017 label elements in English |
| 10 | Instructions for Use (IFU) in English | Device-specific user instructions |
| 11 | Undertaking / Self-Declaration by AIA | As prescribed under MDR 2017 |
| 12 | Form 27-B (Company Registration with CDSCO) | If not already registered |
| 13 | Challan / Government Fee Receipt | Paid via SUGAM payment gateway |
MD-14 / MD-15 Fee Structure (2026)
| Application Type | Government Fee (₹) | Per Additional Model (₹) |
| MD-14 — New Import License (Class A/B) | 5,000 | 1,000 |
| MD-14 — New Import License (Class C/D) | 15,000 | 3,000 |
| MD-15 — Amendment / Variation | 2,500 | 500 |
| MD-15 — Renewal | 5,000 | 1,000 |
Step-by-Step MD-14 Application Process (Oxygen Concentrator Import License)
- Step 1 — SUGAM Portal Registration: Register the Indian entity on sugamapplication.nic.in and complete Form 27-B (company registration with CDSCO) if not already done.
- Step 2 — Prepare Technical Dossier: Compile all technical, clinical, and commercial documents including AIA agreement, FSC, ISO 13485, test reports, and labelling.
- Step 3 — File MD-14 Application: Submit the completed MD-14 form along with all documents on the SUGAM portal. Pay the government fee online.
- Step 4 — CDSCO Review: CDSCO reviews the application and may raise queries or request additional information within 30 days of submission.
- Step 5 — Query Response: Respond to CDSCO queries with supporting documents within the stipulated timeline (typically 30–90 days).
- Step 6 — Approval and Issuance of MD-15: Upon satisfactory review, CDSCO issues Form MD-15 — the Import License — on the SUGAM portal. The license is valid for 3 years.
Wholesale License for Oxygen Concentrator: MD-41 Application and MD-42 Grant of License
Any entity distributing, supplying, or selling oxygen concentrators to hospitals, clinics, pharmacies, or retailers on a wholesale basis must obtain a Wholesale License (Form MD-42) from the State Licensing Authority (SLA) by filing Form MD-41. This applies to distributors, C&F agents, stockists, and trading companies dealing in oxygen concentrators.
What Is MD-41? (Application for Wholesale License)
MD-41 is the prescribed application form under MDR 2017 for entities applying for a wholesale distribution license for medical devices including oxygen concentrators. It is filed with the State Licensing Authority of the state where the wholesale premises is located. Unlike import and manufacturing licenses, the wholesale license is a state-level authorization.
What Is MD-42? (Grant of Wholesale License)
MD-42 is the Wholesale License granted by the SLA after reviewing the MD-41 application and inspecting the wholesale premises. It is a site-specific license — each distribution warehouse or godown requires a separate MD-42. The license is typically valid for 5 years and is renewable before expiry.
Eligibility for MD-41 / MD-42 Wholesale License
- Registered Indian Entity: Pvt Ltd, LLP, Proprietorship, or Partnership firm registered in India.
- Wholesale Premises: Dedicated storage facility meeting MDR 2017 storage requirements (temperature, humidity, clean environment).
- Responsible Person: At least one person with minimum qualification of B.Sc. (Biology/Physics/Chemistry) or Diploma in Medical Devices Technology.
- Valid Storage Conditions: Storage area must have adequate shelving, ventilation, and a maintained temperature log.
- Supply Source: Must procure devices only from CDSCO-registered manufacturers or licensed importers.
Documents Required for MD-41 Application (Wholesale License)
| S.No. | Document | Remarks |
| 1 | Completed Form MD-41 | Signed by authorized signatory |
| 2 | Certificate of Incorporation / GST Registration | Legal entity proof |
| 3 | Premises Ownership / Rental Agreement | For wholesale storage site |
| 4 | Site Plan / Layout of Wholesale Premises | Area and facilities shown |
| 5 | Qualified Person Details (Responsible Person) | Educational and experience proof |
| 6 | Declaration of Responsible Person | Consent to act as qualified person |
| 7 | Affidavit of Proprietor / Director | Confirming compliance with MDR 2017 |
| 8 | Challan / Government Fee Receipt | Paid to SLA as applicable |
MD-41 / MD-42 Fee Structure (2026)
| Application Type | State Fee (Indicative ₹) |
| MD-41 — New Wholesale License | ₹2,000 – ₹5,000 (varies by state) |
| MD-42 — Amendment | ₹1,000 – ₹2,500 (varies by state) |
| MD-42 — Renewal (5-year license) | ₹2,000 – ₹5,000 (varies by state) |
Note: State governments set their own fee schedules. Confirm the exact fee with your State Licensing Authority before applying.
How to Apply on the SUGAM Portal — Step-by-Step
- Register on SUGAM: Create a login ID for your company on the SUGAM portal using your company's GST number and company name.
- Complete Company Profile (Form 27-B): File Form 27-B to register your company with CDSCO. This is mandatory before filing any product application.
- Select Application Type: Choose 'Import License', 'Manufacturing License', or 'Wholesale License' from the application menu.
- Fill Application Form: Complete the prescribed form (MD-3, MD-7, MD-14, or MD-41) online. Enter device details, manufacturer information, and upload all required documents.
- Pay Government Fee: Pay the applicable fee via online banking / NEFT through the SUGAM payment gateway. Download and save the challan.
- Submit Application: Submit the application digitally. CDSCO will assign an application tracking number.
- Track Application Status: Monitor the application status on the SUGAM portal. Respond to any CDSCO queries promptly.
- Download License: Once approved, download the issued license (MD-5, MD-9, MD-15, or MD-42) from the SUGAM portal.
Applicable Standards for Oxygen Concentrators in India (2026)
| Standard | Description | Applicable To |
| IEC 80601-2-69 | Particular requirements for oxygen concentrator equipment | All Oxygen Concentrators |
| ISO 80601-2-69 | Medical electrical equipment — oxygen concentrators (ISO aligned) | All Oxygen Concentrators |
| IEC 60601-1 | General safety and essential performance for medical electrical equipment | All electrical medical devices |
| IEC 60601-1-2 | Electromagnetic compatibility (EMC) requirements | All electrical devices |
| ISO 13485:2016 | Quality Management System for Medical Devices | Manufacturers |
| BIS IS 13450 | Indian standard for oxygen concentrators (where applicable) | India-specific compliance |
Benefits of Obtaining a CDSCO License for Oxygen Concentrator
- Legal Market Access: Only CDSCO-licensed products can be legally sold, imported, or distributed in India. Without a valid license, products are subject to seizure and legal action.
- Government Tender Eligibility: Government hospitals and public procurement agencies (GeM portal) require CDSCO-licensed medical devices — a license is prerequisite to winning government contracts.
- Hospital and Institutional Sales: Private hospitals, corporate hospital chains, and institutional buyers verify CDSCO license status before placing orders.
- Export Credibility: CDSCO registration signals regulatory compliance and strengthens your position in export markets as a quality-assured manufacturer.
- Brand Trust and EEAT: Regulatory approval signals product safety to end-users and caregivers, building brand trust in a sensitive, life-critical product category.
- Insurance & Liability Protection: Licensed manufacturers and importers are better positioned against product liability claims as they carry documented compliance evidence.
License Validity and Renewal Timeline
| License Type | Form | Validity | Renewal Window |
| Manufacturing License (Class B) | MD-5 | Permanent (subject to compliance) | Annual renewal fee applicable |
| Manufacturing License (Class C/D) | MD-9 | Permanent (subject to compliance) | Annual renewal fee applicable |
| Import License | MD-15 | 3 Years | Apply 6 months before expiry |
| Wholesale License | MD-42 | 5 Years | Apply 3 months before expiry |
Post-Market Compliance Obligations After CDSCO License (2026)
- Adverse Event Reporting (MDR): Report any serious device malfunction, near-miss, or patient injury to CDSCO within 30 days of becoming aware.
- Periodic Safety Update Reports (PSUR): Class B and above devices may require periodic safety summaries — check with CDSCO for schedule.
- Field Safety Corrective Actions (FSCA): Issue voluntary recalls or corrections for defective batches in coordination with CDSCO.
- Labelling Compliance: All marketed oxygen concentrators must carry MDR 2017-compliant labels including UDI (Unique Device Identifier), manufacturer address, and manufacturing/expiry date.
- QMS Maintenance: ISO 13485 certificate must remain valid. Manufacturers must undergo surveillance audits by ISO certification bodies.
- Annual Returns: File annual statements with CDSCO/SLA as required under MDR 2017 for ongoing license maintenance.
2026 Regulatory Updates: What's Changed for Oxygen Concentrator Licensing
- Regulatory Alert 2026: CDSCO has reinforced enforcement of MDR 2017 across the oxygen concentrator segment following COVID-19 era quality concerns. Unregistered imports and sub-standard concentrators are facing recall orders and prosecution in 2025–26.
- UDI Implementation: CDSCO is progressively rolling out Unique Device Identification (UDI) requirements. Oxygen concentrator manufacturers and importers should prepare UDI labelling ahead of mandatory enforcement.
- Performance Standard Enforcement: CDSCO has issued directions for stricter compliance with IEC 80601-2-69 performance standards — particularly oxygen purity output (≥90%) and alarm systems.
- SUGAM 2.0 Upgrades: The SUGAM portal has undergone upgrades for faster processing and e-KYC verification of applicants in 2025–26.
- Mandatory Device Registration Before Import: Relaxations granted during COVID-19 for emergency imports have been withdrawn — all oxygen concentrator imports now require prior CDSCO registration and MD-15 import license.
- QCO Integration: Discussions are underway to bring oxygen concentrators under BIS Quality Control Orders (QCOs) — manufacturers should monitor MoHFW and DPIIT notifications for updates.
Why Choose Silvereye Certifications for Your CDSCO Oxygen Concentrator License?
- End-to-End License Management: From document preparation and SUGAM filing to query response and license tracking — we handle the entire CDSCO licensing lifecycle for oxygen concentrators.
- Regulatory Expertise: Deep domain expertise across all MDR 2017 device classes, import licensing, manufacturing compliance, and wholesale distribution regulations.
- Proven Track Record: Successfully guided manufacturers, importers, and distributors in obtaining MD-5, MD-15, and MD-42 licenses for life-critical medical devices.
- 2026 Compliance Ready: We stay updated on every CDSCO notification, guideline, and portal change so your application is always submitted correctly the first time.
- Transparent Timelines and Pricing: No hidden charges. Clear milestones. Dedicated regulatory consultant assigned to every project.
Frequently Asked Questions
Is an oxygen concentrator a Class B medical device under CDSCO?
Yes. Standard oxygen concentrators — both portable and stationary — are classified as Class B (moderate low-risk) medical devices under Schedule I of the Medical Devices Rules, 2017. This applies to all models intended for home use, clinical use, or hospital use.
Which form do I use to apply for a CDSCO import license for an oxygen concentrator?
You must file Form MD-14 on the SUGAM portal to apply for an import license. Upon CDSCO approval, Form MD-15 is issued as the grant of import license. A separate MD-15 is required for each model from each overseas manufacturer.
Can I sell imported oxygen concentrators in India without a CDSCO license?
No. Selling, distributing, or supplying oxygen concentrators in India without a valid CDSCO import license (MD-15) and wholesale license (MD-42) is a punishable offence under the Drugs and Cosmetics Act, 1940, liable to seizure, fine, and imprisonment.
How long does it take to get a CDSCO import license for an oxygen concentrator?
The processing time for an MD-15 import license is typically 90 to 180 days for new applications, depending on document completeness, CDSCO query cycles, and workload. Engaging an experienced regulatory consultant and submitting a complete dossier can significantly reduce timelines.
What is the government fee for an MD-14 application for a Class B oxygen concentrator?
The government fee for a new MD-14 import license application for Class B devices is ₹5,000 for the first model, with an additional ₹1,000 per additional model included in the same application. Fees are paid online through the SUGAM portal.
Do I need a wholesale license (MD-42) to distribute oxygen concentrators?
Yes. Any entity engaged in wholesale distribution, stockisting, or redistribution of oxygen concentrators must obtain Form MD-42 (Wholesale License) from the State Licensing Authority of the state where the distribution premises is located, by applying through Form MD-41.
What documents does a foreign manufacturer need to provide for MD-14?
The foreign manufacturer must provide: ISO 13485 certificate, Free Sale Certificate (apostilled), Declaration of Conformity, home country regulatory approval (FDA 510k, CE, TGA, etc.), technical documentation per IEC 80601-2-69, and a notarized Authorized Indian Agent agreement.
Is the MD-15 import license device-specific or company-wide?
MD-15 is both device-specific and manufacturer-specific. You need a separate import license for each unique oxygen concentrator model (identified by model number) from each foreign manufacturer. One license cannot cover multiple models unless they were included in the same application and approved together.
How long is the MD-15 import license for oxygen concentrators valid?
The MD-15 import license is valid for 3 years from the date of issue. It must be renewed before expiry. It is advisable to initiate the renewal process at least 6 months before the expiry date to avoid a lapse in authorization.
What happens if I import oxygen concentrators without a CDSCO registration?
Importing oxygen concentrators without CDSCO registration and a valid MD-15 license is illegal under MDR 2017. Consequences include: product seizure at Indian customs ports, legal prosecution under the Drugs and Cosmetics Act, financial penalties, and permanent market ban for repeat offenders. CDSCO has been actively enforcing this in 2025–26.
