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Must-Have CDSCO License to Manufacture Respiratory Products in India

Respiratory products are an integral part of the medical device landscape in India, governed by the Central Drugs Standard Control Organization (CDSCO) Medical Device Licensing Regime. Under this robust regulatory framework, respiratory devices such as ventilators, oxygen concentrators, and CPAP machines undergo rigorous evaluation to ensure their safety and efficacy.

This regulatory oversight underscores the commitment to quality and patient well-being, making CDSCO’s medical device licensing regime a cornerstone for respiratory product manufacturers and healthcare providers alike.

The Central Drugs Standard Control Organization (CDSCO) mandates the possession of a valid Medical Device License for any entity involved in the manufacturing, importation, sale, or distribution of Respiratory Products within India.

Licensing authorities for Respiratory Products in India

The Central Drugs Standard Control Organization (CDSCO) is the licensing authority for Class C and Class D Respiratory Products and the State Licensing Authority is the licensing authority for Class A and Class B Respiratory Products in India.

List of “Class A” Respiratory Products

  • Bulk oxygen concentration system
  • Cardiopulmonary resuscitation mask
  • Cough long-term ambulatory recording system
  • Steam inhaler
  • Stress test treadmill
  • Tracheostoma protective filter
  • Tracheostoma protector
  • Tracheostomy tube lubricant
  • Valsalva manoeuvre mouthpiece
  • Video intubation laryngoscope handle/monitor
  • Public respirator (2 ply, 3 ply face mask)

List of “Class B” Respiratory Products

  • Activated-oxygen generator
  • Argon gas analyser
  • Artificial airway tube cuff pressure monitor
  • Cerebral oximeter
  • Chest-oscillation airway secretion-clearing system
  • Chest-percussion airway secretion-clearing system
  • Cold-air diagnostic inhalation system
  • Cricothyrotome
  • Dry powder inhaler
  • Dry salt therapy device
  • Electroacoustical airway secretion-clearing system
  • Endotracheal tube introducer
  • Exhaled-gas oesophageal intubation detector
  • Foetal pulse oximeter
  • Gas pipeline/supply system air compressor
  • Heated respiratory humidifier
  • Home-use sleep apnoea recording system
  • Impedance pneumography recording/analysis system
  • Infant apnoea monitor
  • Manual chest percussor
  • Nitrogen monoxide analyser
  • Nitrous oxide analyser
  • Pulse oximetry telemetric monitoring system
  • Respiratory apnoea monitoring system
  • Thoracic bioconductance measurement system
  • Thoracic electrical impedance segmentography system
  • Thoracic suction pump
  • Tongue-adjustment sleep apnoea treatment system
  • Transcutaneous blood gas monitoring system
  • Whole-body plethysmograph
  • Diagnostic Spirometer
  • Monitoring Spirometer
  • Oxygen Concentrator

List of “Class C” Respiratory Products

  • Hyperbaric chamber
  • Implantable sleep apnoea treatment system
  • Therapeutic positive pressure breathing ventilator

Are You Looking for CDSCO License to Manufacture and Import Respiratory Products in India?

Contact MedDev Experts today! We have a team of experienced professionals who can help you navigate the complex regulatory process and get your license approved.

Respiratory Products Licensing Requirement:

  • To manufacture Class A and Class B Respiratory Products in India, you must obtain the MD 5 License from the State Licensing Authority.
  • To manufacture Class C Respiratory Products in India, you must obtain the MD 9 License from the Central Drugs Standard Control Organization (CDSCO).
  • To import Respiratory Products into India, you must obtain the MD 15 Import License from the CDSCO.

Requirements for Manufacturing, Importing, and Distributing Respiratory Products in India

License Fee for Respiratory Products in India

  • Class A or Class B: ₹ 5,000/- for manufacturing license, ₹ 500/- for each distinct device.
  • Class C or Class D: ₹ 50,000/- for manufacturing license, ₹ 1,000/- for each distinct device.

Validity of Respiratory Products License in India

  • Respiratory Products licenses are valid indefinitely, as long as the retention fee is paid every 5 years.

How to Apply Online for Respiratory Products Manufacturing or Import License in India

  • Step 1: Enroll your organization on CDSCO’s SUGAM Portal.
  • Step 2: Fill in the respective applications and submit them through CDSCO’s online SUGAM Portal.
  • Step 3: Upload the necessary documents and make the required payment.
  • Step 4: Your application will be scrutinized by the CDSCO Team. If it meets the requirements, it will proceed to a quality management system compliance audit.
  • Step 5: The Team will conduct an audit at your manufacturing premises. If any Non-Conformance (NC) is identified, you will be required to submit an NC closure report.
  • Step 6: Once all the conditions are met, CDSCO will grant the license.

Deadline for Obtaining Respiratory Products Licenses in India

The deadline for obtaining Respiratory Products licenses in India is October 1, 2022 for Class A and Class B devices, and September 30, 2023 for Class C and Class D devices.

List of Documents for Obtaining a Respiratory Products Manufacturing Licenses in India

  • Organization identity proof: This could be the Memorandum of Association, List of Directors or Partners, UDYAM Aadhar, or PAN card.
  • Sale Deed / Rent Deed of the Premises: This document proves that you have legal ownership of the premises where you will be manufacturing the medical devices.
  • Plant or Site Master File: This file contains information about the layout of your manufacturing facility, as well as the equipment and processes you will be using.
  • Building Layout with Dimension: This is a detailed drawing of your manufacturing facility, showing the dimensions of each room and the location of all equipment.
  • ISO 13485 Certificate and Previous Audit Reports: This certificate shows that your manufacturing facility meets international standards for quality management systems.
  • Competent Technical Staff for Manufacturing and Testing of Devices: You must have a team of qualified and experienced staff who can manufacture and test your medical devices.
  • Device Master File: This file contains detailed information about each medical device you will be manufacturing, including its design, manufacturing process, and testing procedures.
  • Test License, if any: If you need a license to test your medical devices, you must obtain it before you can start manufacturing them.
  • Compliance with the environmental requirements: You must comply with all applicable environmental regulations, such as those related to cleanrooms for manufacturing the devices.
  • Certificate of Analysis of 3 Consecutive Batches: This certificate shows that the first 3 batches of medical devices you manufactured meet the required quality standards.

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