Posted by The market size of respiratory devices in India is steadily growing and is set to reach USD 1.31 billion by 2030. This is a right opportunity for businesses, both domestic and foreign, to capitalise on this growing demand for medical instruments for respiratory care. However, to start import or manufacturing, you need a CDSCO respiratory medical devices license. It means complying with the official guidelines set by the issuing authority to ensure the quality and efficacy of your devices.
The road to regulatory approval can feel long and tedious, but with the support of Dueran Consultant, you can ease the process and make it swift.
What Are Respiratory Medical Devices?
Respiratory medical devices are instruments used in clinical and residential settings to help patients breathe. Based on their design and features, they perform differently. Some, like anaesthesia machines, are used to generate and mix gases, while others, like airway pressure alarm, monitor the upper airway pressure of the patient during mechanical ventilation. These instruments perform the following major functions:
- Supporting or controlling the breathing
- Keeping airways open
- Delivering medication to the lungs
- Providing supplemental oxygen
- Monitoring respiratory status
- Clearing airways
Why Is the CDSCO Respiratory Medical Devices License Important?
Respiratory medical devices should be made according to stringent standards and protocols. If manufacturers and importers promote devices that don’t follow these standards, the potential risk for patients increases significantly. This is why business entities need a manufacturing or Import license for respiratory medical devices.
Respiratory medical devices license in India is given by CDSCO (Central Drugs Standard Control Organization) and SLA (State Licensing Authority) based on the risk class of your device. The licensing process involves rigorous documentation, quality system audits, and compliance checks (including ISO 13485 certification and batch analysis). All of this ensures that your devices are safe and effective for medical use, both for the patient and clinicians. Without compliance checks, you won’t get regulatory approval to produce or import devices into India.
CDSCO Classification of Respiratory Medical Devices
The CDSCO classifies respiratory medical devices based on the risk they pose to patients. The classification is according to the Medical Devices Rules, 2017. On this basis, devices fall into Class A, B, C and D. Class A & B respiratory medical devices have the low to moderate risk, and Class C & D devices poses moderate to High risk. As per the CDSCO respiratory medical devices guidelines, your product must fall into one of these classes, without which you cannot submit the online application for the license.
This table shows the CDSCO classification of respiratory medical devices in India:
|
Sr. No. |
Medical Device Name |
Risk Class |
| 1 | Activated-oxygen generator | B |
| 2 | Argon gas analyser | B |
| 3 | Artificial airway tube cuff pressure monitor | B |
| 4 | Bulk oxygen concentration system | A |
| 5 | Cardiopulmonary resuscitation mask | A |
| 6 | Cerebral oximeter | B |
| 7 | Chest-oscillation airway secretion-clearing system | B |
| 8 | Chest-percussion airway secretion-clearing system | B |
| 9 | Cold-air diagnostic inhalation system | B |
| 10 | Cough long-term ambulatory recording system | A |
| 11 | Cricothyrotome | B |
| 12 | Dry powder inhaler | A |
| 13 | Dry salt therapy device | A |
| 14 | Electroacoustical airway secretion-clearing system | B |
| 15 | Endotracheal tube introducer | A |
| 16 | Exhaled-gas oesophageal intubation detector | A |
| 17 | Foetal pulse oximeter | B |
| 18 | Gas pipeline/supply system air compressor | B |
| 19 | Heated respiratory humidifier | B |
| 20 | Home-use sleep apnoea recording system | B |
| 21 | Hyperbaric chamber | C |
| 22 | Hypopnea sensor/alarm | B |
| 23 | Impedance pneumography recording/analysis system | B |
| 24 | Implantable sleep apnoea treatment system | C |
| 25 | Infant apnoea monitor | B |
| 26 | Manual chest percussor | B |
| 27 | Nitrogen monoxide analyser | B |
| 28 | Nitrous oxide analyser | B |
| 29 | Pulse oximetry telemetric monitoring system | B |
| 30 | Respiratory apnoea monitoring system | B |
| 31 | Steam inhaler | A |
| 32 | Stress test treadmill | A |
| 33 | Therapeutic air ionizer | A |
| 34 | Therapeutic positive pressure breathing ventilator | C |
| 35 | Thoracic bioconductance measurement system | B |
| 36 | Thoracic electrical impedance segmentography system | B |
| 37 | Thoracic electrical impedance tomography system | C |
| 38 | Thoracic suction pump | B |
| 39 | Tongue-adjustment sleep apnoea treatment system | B |
| 40 | Tracheostoma protective filter | A |
| 41 | Tracheostoma protector | A |
| 42 | Tracheostomy tube lubricant | A |
| 43 | Transcutaneous blood gas monitoring system | B |
| 44 | Valsalva manoeuvre mouthpiece | A |
| 45 | Video intubation laryngoscope handle/monitor | A |
| 46 | Whole-body plethysmograph | B |
| 47 | Diagnostic Spirometer | B |
| 48 | Monitoring Spirometer | B |
| 49 | Oxygen Concentrator | B |
| 50 | Pulmonary function analysis system | B |
| 51 | Public respirator (2 ply, 3 ply face mask) | A |
The Process to Secure a CDSCO Respiratory Medical Devices License
To secure a manufacturing or medical devices import license for your medical instruments, you must follow these systematic steps, as mentioned below.
1. Check Device Classification and Notification Status:
Confirm the classification (Class A, B, C, D) of your respiratory medical device according to the table above. This classification determines the type of license (Form MD-05 & Form MD-06 for Class A/B from State Authority, Form MD-09 & Form MD-10 for Class C/D from Central Authority).
2. Know the Type of License You Need & the Issuing Authority
The next step is finding out the type of license you need for your specific purpose, whether it is manufacturing, importing devices, producing them for the Test or Evaluation.
- Test Licenses (Form MD‑13): It is issued by the Central Licensing Authority (CLA) for the purposes of Clinical Investigations, Test or Evaluation, Demonstration, Training of respiratory medical devices.
- Manufacturing License (for sale/distribution): Form MD‑5 is required for manufacturing of Class A & B Medical devices, and Form MD‑9 is required for Class C & D Medical devices.
- Loan License: This license is needed when you want to utilized the facility of another licensed manufacturer to produce devices under their manufacturing license (Form MD‑6 is required for manufacturing of Class A & B Medical devices, and Form MD‑10 is required for Class C & D Medical devices).
- Import License (Form MD‑15): This license is mandatory for importing all classes of medical devices, excluding Non-sterile & Non-measuring Class A devices.
3. Appoint an Indian Authorised Agent (for Foreign Manufacturers):
If you are a manufacturer outside India, appoint an Indian Authorised Agent or Representative. They will handle the application, act as the liaison with CDSCO, and manage regulatory communications. The authorized agent ensures that your devices meet all relevant Indian requirement and regulations, like those given in the Medical Device Rules, 2017. They are also responsible for post-market surveillance activities, manage complaints and product recalls on your behalf.
4. Prepare Documents
Proper documentation is a huge part of securing the respiratory medical devices license in India. Here’s the list of documentation:
- Plant Master File and Device Master File
- ISO 13485 (Quality management system) certification
- Certificate of analysis for 3 consecutive batches
- CE certificates
- Power of Attorney
- Free sale certificate
5. Submit Application Online on Medical Device Sugam Portal
Medical Device Sugam Portal is an e-governance portal meant for submitting applications to manufacture and import devices. Retailers and wholesalers applying for a drug license can also use it. Labs and testing agencies for respiratory support medical devices also use the portal for application submission. Use these steps to submit your applications.
- Visit the official CDSCO Medical Device Sugam portal.
- Choose your application type.
- Fill in all your details and upload the needed documents.
- Submit the form.
- You will soon receive a confirmation email.
Afterwards, log in to the portal again to track your application status. This will enable you to know whether your request for obtaining the CDSCO respiratory medical devices license is approved, rejected, or under review.
6. Audit by the authorities (Domestic Manufacturer)
Concern authority will review your application and documentation and may ask for additional information to ensure compliance. You must address their queries on time to prevent delay or application rejection. The officials also do a facility inspection to verify compliance with manufacturing practices, quality systems, and regulatory standards. Be prepared for concern authority assessment and maintain proactiveness if you want to get a valid license soon.
7. Approval and Post-Licensing Compliance
Upon successful evaluation of documents and inspection, CDSCO will issue the manufacturing or import license for respiratory medical devices. It is valid indefinitely but requires a retention fee payment every five years to maintain validity. Throughout this period, importers or manufacturers must adhere to the CDSCO rules and maintain readiness for regular audits or renewals.
CDSCO Fee Structure (License & Permission) for Respiratory Medical Devices
| Device Class | Government Fees | Licensing Authority | Required Licenses |
| Manufacturing License | |||
| Class A | Rs. 5,000 for one site and Rs. 500 for each medical device. | State Licensing Authority (SLA) | Form MD 5/ Form MD 6 |
| Class B | Rs. 5,000 for one site and Rs. 500 for each medical device. | State Licensing Authority (SLA) | |
| Class C | Rs. 50,000 for one site and Rs. 1,000 for each medical device. | CDSCO (Central Licensing Authority) | Form MD 9/ Form MD 10 |
| Class D | Rs. 50,000 for one site and Rs. 1,000 for each medical device.
|
CDSCO (Central Licensing Authority) | |
| Import License | |||
| Class A | USD 1,000 for one Foreign manufacturing site and USD 50 for each medical device. | CDSCO (Central Licensing Authority) | Form MD 15 |
| Class B | USD 2,000 for one Foreign manufacturing site and USD 1,000 for each medical device.
|
CDSCO (Central Licensing Authority) | |
| Class C | USD 3,000 for one Foreign manufacturing site and USD 1,500 for each medical device.
|
CDSCO (Central Licensing Authority) | |
| Class D | USD 3,000 for one Foreign manufacturing site and USD 1,500 for each medical device.
|
CDSCO (Central Licensing Authority) | |
How Dueran Consultant Helps You?
Selling or promoting unregistered respiratory devices during the approval process is illegal. However, the process to secure a CDSCO respiratory medical devices license is lengthy and rife with challenges for new businesses and foreign manufacturers. At Dueran Consultant, we’ve been helping business owners with expert guidance and personalised strategies to make the compliance process easy.
From helping you navigate the regulatory landscape for your device to assistance with documentation and communicating with the issuing authorities on your behalf, we hold your hand throughout the process. If you’re keen on regulatory approval and kickstarting a flourishing business in India, let us know how we can help you.
