CDSCO is at the forefront of ensuring that medical devices in India meet the highest standards of safety and efficacy. The Central Drugs Standard Control Organization (CDSCO), apex regulatory body for medical devices, has laid down stringent regulatory guidelines. Thus, all medical device manufacturers and importers are required to abide by these guidelines. Respiratory devices, given their critical role in patient care, are of particular regulatory importance. Moreover, these devices are pivotal in treating respiratory conditions. Hence, the CDSCO has laid down strict guidelines specifically for manufacturing and importing respiratory medical devices. Therefore, securing a CDSCO license for respiratory medical devices is mandatory. This guide offers a deep dive into the CDSCO registration and licensing nuances for respiratory devices.

Understanding Respiratory Medical Device Classification System

The CDSCO has introduced the medical device classification system to simplify the CDSCO medical device license application process. Medical devices are classified based on the potential risks associated with their use. The respiratory medical devices are also categorised into different classes. It is important to check which class your medical device belongs to before proceeding with the CDSCO respiratory medical devices license application. The process of application for CDSCO respiratory devices license varies depending on the CDSCO class.

Respiratory Medical Device Classes

We have provided examples of some medical devices belonging to the different CDSCO classes.

CDSCO class A:

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

CDSCO class B:

• 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
• Endotracheal tube introducer
• Exhaled-gas oesophageal intubation detector
• Foetal pulse oximeter
• Gas pipeline/supply system air compressor
• Heated respiratory humidifier
• Tongue-adjustment sleep apnoea treatment system
• Diagnostic Spirometer
• Monitoring Spirometer
• Oxygen Concentrator
• 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

Class C:

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

Securing the CDSCO License for Respiratory Medical Devices

Regulatory compliance is a testament of the manufacturer’s dedication to patient safety and product quality. Furthermore, staying compliant instils trust in the brand and helps avoid potential legal repercussions. Thus, respiratory medical device companies should abide by the CDSCO regulations. Hence, they are mandatorily required to secure the CDSCO respiratory medical device license.

CDSCO License for Respiratory Medical Devices: Forms and Requirements

• Manufacturing class A and B respiratory devices: MD 5 License is required for manufacturing class A and B respiratory devices. Moreover, a fee of Rs. 5,000 for the manufacturing license and Rs. 500 for each distinct device is required. The license has to be obtained from the state licensing authority.
• Manufacturing class C and D respiratory devices: MD 9 License is required for manufacturing class C and D respiratory devices. Moreover, a fee of Rs. 50,000 for the manufacturing license and Rs. 1,000 for each distinct device is required. The license has to be obtained from the central licensing authority.
• Importing respiratory devices into India: The MD 15 Import License has to be secured from the CDSCO to import respiratory devices into India.

Documents Required to Apply for CDSCO License for Respiratory Medical Devices

We have provided an overview of the documents required for securing CDSCO respiratory medical devices license.

1. Plant Master File
2. Building Layout with Dimension
3. Device Master File
4. Organization identity proof
5. Sale Deed/Rent Deed of the Premises
6. Documents for the team of qualified and experienced staff who can manufacture and test your medical devices.
7. Environmental regulation compliance documents
8. Certificate of analysis of 3 consecutive batches
9. ISO 13485 Certificate
10. Test License, if required for testing the respiratory medical device

An Overview of the Application Process for the CDSCO License for Respiratory Medical Devices

Navigating the CDSCO registration process for respiratory devices involves:

• Document preparation: The documents have to be prepared per CDSCO guidelines. Additionally, they have to be arranged per CDSCO requirements.
• Application Submission: The correct application form has to be filled in and submitted online along with all the documents.
• Query Resolution: Addressing any queries raised by CDSCO in a timely manner.
• Inspection: Preparing for the CDSCO facility inspection and audit.
• License Approval: The regulatory officials will review the application and verify the documents. Upon meeting all criteria, CDSCO will grant the license.

New Guidelines for CDSCO License for Respiratory Medical Devices

With the evolving medical device landscape, CDSCO constantly updates its guidelines to ensure respiratory devices are of the highest standard. Special emphasis is given to rigorous testing and quality checks, especially for class C and D devices. This ensures they are fit for their intended medical use and safe for the patients.

The Deadline: Key Dates to Remember for CDSCO Respiratory Medical Devices License Application

CDSCO has transitioned Class C and Class D respiratory devices from a mandatory registration system to a licensing structure. This has been detailed in GSR 102(E) dated 11.02.2020. Notably, this change will be in effect from October 1, 2023. For a more in-depth understanding, the official CDSCO circular serves as a comprehensive resource.

Validity of the CDSCO Respiratory Medical Devices License

The CDSCO respiratory medical devices license is valid indefinitely. However, to maintain the validity, the license retention fee has to be paid every 5 years.

Common License Application Challenges and How to Overcome Them

Manufacturers and importers might face the following hurdles while applying for the CDSCO respiratory devices license:

• Documentation Gaps: Ensuring all documents are up-to-date and meet CDSCO’s requirements.
• Delays in Query Resolution: Setting up a dedicated team to address CDSCO queries promptly.
• Inspection Hurdles: Regular internal reviews of facilities to ensure they meet CDSCO guidelines.

How Can Pharmadocx Consultants Assist in Securing the CDSCO License for Respiratory Medical Devices?

Pharmadocx Consultants offers a suite of services tailored for respiratory device manufacturers:

• Expert Guidance: Assistance throughout the registration process.
• Mock Audits: Conducting pre-inspection audits to ensure readiness.
• Query Resolution: Promptly addressing CDSCO queries.
• End-to-End Support: Comprehensive support from the initial application to license approval.

The CDSCO regulatory guidelines for respiratory devices ensure that healthcare professionals are equipped with the best tools for patient care. Hence, securing the CDSCO respiratory medical devices license is mandatory. With our support, your CDSCO license application journey will be streamlined and efficient.

Need expert guidance for easily securing the CDSCO license for respiratory medical devices? Drop an email at [email protected] or call/Whatsapp on 9996859227 and we will be more than happy to help you.