An Oxygen Concentrator Manufacturing License is a mandatory approval that manufacturers must obtain before producing and selling oxygen concentrators in India. These devices play a vital role in healthcare by providing a continuous flow of medical-grade oxygen to patients with respiratory issues. Since oxygen concentrators are considered medical devices, their manufacturing is strictly regulated by the Central Drugs Standard Control Organisation (CDSCO) under the Medical Device Rules (MDR), 2017.
This license ensures that only safe, reliable, and quality-tested devices are supplied in the market. Let’s explore everything you need to know about the Oxygen Concentrator Manufacturing License in India.
What is an Oxygen Concentrator Manufacturing License in India?
An Oxygen Concentrator Manufacturing License is an official approval issued by CDSCO that allows companies to legally manufacture oxygen concentrators in India. It confirms that the manufacturer follows the required quality, safety, and regulatory standards.
- Without this license, production and distribution are considered illegal under Indian medical device regulations.
- It also assures hospitals, patients, and importers that the product meets national and international healthcare standards.
Why is an Oxygen Concentrator Manufacturing License required?
The Oxygen Concentrator Manufacturing License is required for the following reasons:
- To ensure patient safety by manufacturing devices that meet medical standards.
- To comply with Medical Device Rules, 2017, and avoid penalties.
- To make products eligible for supply to hospitals, government tenders, and exports.
- To build credibility and trust in the healthcare market.
Which Authority issues the Oxygen Concentrator Manufacturing License?
The Oxygen Concentrator Manufacturing License is issued by the Central Drugs Standard Control Organisation (CDSCO), which operates under the Ministry of Health and Family Welfare (MoHFW), Government of India.
- For Class A & B devices – License is issued by State Licensing Authority (SLA).
- For Class C & D devices – License is issued directly by CDSCO (Central Licensing Authority).
What are the Eligibility Criteria for an Oxygen Concentrator Manufacturing License?
To obtain an Oxygen Concentrator Manufacturing License, a manufacturer must meet certain eligibility requirements:
| S.No. | Eligibility Criteria | Details |
|---|---|---|
| 1. | Legal Entity | Must be a registered company/partnership/LLP in India. |
| 2. | Manufacturing Facility | Should have a proper setup with equipment, cleanroom, and infrastructure. |
| 3. | Quality Management System (QMS) | Must comply with ISO 13485 standards. |
| 4. | Qualified Technical Staff | Appointment of competent technical staff with relevant qualifications. |
| 5. | Compliance | Facility must follow MDR, 2017 guidelines and Good Manufacturing Practices (GMP). |
What Documents are required for an Oxygen Concentrator Manufacturing License?
To apply for an Oxygen Concentrator Manufacturing License, the following documents are required:
- Company registration documents (Incorporation/Partnership deed).
- Manufacturing site master file.
- Plant layout with equipment details.
- Details of technical staff with qualification certificates.
- ISO 13485 certification (QMS compliance).
- Undertaking for compliance with MDR, 2017.
- Device Master File (DMF) for oxygen concentrators.
- Fees payment challan.
What is the Process of obtaining an Oxygen Concentrator Manufacturing License?
The process of obtaining an Oxygen Concentrator Manufacturing License is systematic and regulated by CDSCO:
- Preparation – Collect documents like DMF, site master file, ISO certification.
- Application Filing – Submit Form MD-3 (for Class A/B) or MD-7 (for Class C/D) through the CDSCO portal.
- Fee Payment – Pay the applicable government fees.
- Inspection – SLA/CDSCO conducts a site inspection to verify compliance.
- Approval – If all requirements are met, the license is issued in Form MD-5 (for A/B) or MD-9 (for C/D).
How are Oxygen Concentrators Classified as Medical Devices under CDSCO?
Oxygen concentrators are classified under the Medical Device Rules, 2017 as Class C medical devices because they are life-supporting and moderate-to-high risk devices.
What are the Compliance Requirements After Obtaining an Oxygen Concentrator Manufacturing License?
After receiving an Oxygen Concentrator Manufacturing License, manufacturers must follow strict compliance requirements:
- Maintain ISO 13485 QMS certification.
- Submit periodic safety and performance reports.
- Allow CDSCO inspections anytime.
- Ensure devices meet BIS standards for safety and performance.
- Report any adverse events or device malfunctions immediately.
- Renew license and update documents regularly.
Is it Mandatory to have an Oxygen Concentrator Manufacturing License in India?
Yes, it is mandatory under the Medical Device Rules, 2017, as oxygen concentrators are classified as Class C medical devices.
How Long does it take to get an Oxygen Concentrator Manufacturing License?
The approval process generally takes 3 to 6 months, depending on document readiness and CDSCO inspection timelines.
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