Posted by It is essential for manufacturers and importers to understand the registration process for anaesthesia medical devices in India. It requires a license by the Licensing authority under Medical Device Rules, 2017. The license is evidence of the safety and quality of your devices. In this post, we’ll explain the registration process in detail and the major challenges that potentially arise in this process. You will also find out how our expertise can make the road to getting approval less bumpy.
What is Anaesthesia Medical Devices?
Anaesthesia medical devices are equipment like ventilators, aerosol face mask, anaesthesia machines, airway pressure alarm, and more. Anaesthesia medical devices include a wide range of equipment used to administer anaesthesia and monitor patients during surgical and other medical procedures.
For CDSCO anaesthesia medical device registration, you must know the risk class of your device. Anaesthesia medical devices can be classified in four categories.
- Class A includes low-risk devices, like aerosol delivery tubing.
- Class B includes low-to-moderate-risk devices, like aerosol inhalation monitor
- Class C has moderate-to-high-risk devices, like oxygen Monitor.
- Class D has high-risk devices, like Electronic epidural space locator control unit.
CDSCO’s Regulatory Framework for Medical Devices
The regulatory framework for medical devices in India is governed by the Medical Devices Rules, 2017. The Drugs Controller General of India supervises CDSCO, which act as a Central Licensing Authority in India.
To obtain license for anaesthesia medical devices in India, you need to know the class of your medical device. The classes described above, are based on risk level and intended used of the medical devices. It determines the regulatory pathway and requirements for obtaining the license and impacts the registration and licensing paper work needed from you.
Classification of Medical Devices Pertaining to Anesthesiology
| Sr. No | Medical Device Name | Risk Class |
| 1 | Anesthesia machine | C |
| 2 | Aerosol delivery tubing | A |
| 3 | Aerosol face mask | B |
| 4 | Aerosol inhalation monitor | B |
| 5 | Airway device cleaning utensil | A |
| 6 | Airway pressure alarm | A |
| 7 | Airway pressure/oxygen monitor | B |
| 8 | Airway protection face mask | A |
| 9 | Airway temperature monitoring system | B |
| 10 | Airway tube forceps | A |
| 11 | Anaesthesia breathing circuit | B |
| 12 | Anaesthesia catheter Luer connector | A |
| 13 | Anaesthesia depth monitor | B |
| 14 | Anaesthesia depth simulator | A |
| 15 | Anaesthesia instrument table | A |
| 16 | Anaesthesia mask stabilizer | A |
| 17 | Anaesthesia system leakage tester | A |
| 18 | anaesthesia vaporizer | C |
| 19 | Anaesthesia warmer | A |
| 20 | Anaesthesia workstation gas scavenger | B |
| 21 | Anaesthetic gas absorption/desorption device | B |
| 22 | Anaesthetic gas scavenging terminal unit | A |
| 23 | Anesthesia Face Mask | A |
| 24 | Artificial airway stylet | A |
| 25 | Artificial airway washing/disinfection jar | B |
| 26 | Atomizer | A |
| 27 | Brachial plexus anaesthesia kit | B |
| 28 | Breathing circuit bag | A |
| 29 | Breathing circuit condenser | A |
| 30 | Breathing circuit dryer | A |
| 31 | Breathing circuit gas- sampling/monitoring set | B |
| 32 | Breathing circuit washer/disinfector | B |
| 33 | Breathing mouthpiece | A |
| 34 | Bronchoscope | A |
| 35 | Capnography oxygen mask | A |
| 36 | Capnography sampling adaptor | A |
| 37 | Carbon dioxide monitor | C |
| 38 | CPAP/BPAP nasal mask | B |
| 39 | CPAP/BPAP oral mask | B |
| 40 | Electronic epidural space locator control unit | D |
| 41 | Electronic oesophageal stethoscope | B |
| 42 | Endobronchial airway sizing kit | A |
| 43 | Helium/oxygen breathing gas mixer | B |
| 44 | High-frequency ventilator | C |
| 45 | Inhalational analgesia unit | B |
| 46 | In-line arterial blood sampling set | A |
| 47 | In-line backflow valve | A |
| 48 | Intracardiac oximeter | B |
| 49 | Intravascular blood gas/pH monitoring system | B |
| 50 | Intravascular membrane oxygenator | C |
| 51 | Intravascular oximeter | B |
| 52 | Intubation laryngoscope | A |
| 53 | Intubation teeth protector | A |
| 54 | Invasive arterial pressure cardiac output/oximetry monitor | B |
| 55 | Laryngeal airway introducer | A |
| 56 | Laryngectomy tube | B |
| 57 | Laryngotracheal anaesthesia applicator | B |
| 58 | Manual jet ventilation device | C |
| 59 | Mechanical positive pressure airway secretion- clearing device | A |
| 60 | Medical gas flowmeter | A |
| 61 | Medical gas flowmeter, Thorpe tube | A |
| 62 | Medical gas pipeline system | A |
| 63 | Medical gas pipeline system automatic outlet analyser | A |
| 64 | Medical gas pipeline system pressure monitor | A |
| 65 | Medical gas terminal unit | A |
| 66 | Microbial medical gas filter | B |
| 67 | Negative-pressure ventilator | C |
| 68 | Neonatal chest percussor | B |
| 69 | Nerve-block injection manometer | A |
| 70 | Nitric oxide delivery unit | B |
| 71 | Non-heated respiratory humidifier | B |
| 72 | Non-rebreathing oxygen face mask | A |
| 73 | Nose clip | A |
| 74 | Oxygen administration hood | A |
| 75 | Oxygen saturation/pulse rate simulator | A |
| 76 | Oxygen/air breathing gas mixer | B |
| 77 | Patient physiologic monitoring system | C |
| 78 | Pleural manometer | B |
| 79 | Pneumatic chest percussor | B |
| 80 | Pressure algometer/aesthesiometer | B |
| 81 | Pulmonary resuscitator | C |
| 82 | Pulse Co-oximeter | B |
| 83 | Pulse oximeter | C |
| 84 | Rebreathing oxygen face mask | A |
| 85 | Respiration monitor | B |
| 86 | Respiratory oxygen monitor | B |
| 87 | Respiratory oxygen therapy monitor/regulator | B |
| 88 | Rigid non-bladed video intubation laryngoscope | A |
| 89 | Saddle block anaesthesia kit | B |
| 90 | Spinal needle bioimpedance navigation unit | D |
| 91 | Spirometer/pulmonary function analyser syringe | A |
| 92 | Tracheal surgery dilator | A |
| 93 | Tracheotome | A |
| 94 | Ultrasonic cough stimulation system | A |
| 95 | Ultrasonic respiratory humidifier | B |
| 96 | Vacuum-assisted airway secretion-clearing system | B |
| 97 | Venturi oxygen face mask | B |
| 98 | Venturi oxygen face mask | B |
| 99 | Bronchial cannula | A |
| 100 | Bronchoscopy tube | C |
| 101 | Bulk oxygen concentration system | B |
| 102 | Endotracheal secretion monitoring system | B |
| 103 | Epidural anaesthesia kit | C |
| 104 | Laryngeal airway | A |
| 105 | Medicine chamber spacer | A |
| 106 | Nasopharyngeal airway | B |
| 107 | Oropharyngeal airway | A |
| 108 | Oxygen/air/nitrous oxide breathing gas mixer | C |
| 109 | Peak flow meter | B |
| 110 | Pulmonary function analysis system | B |
| 111 | Retrograde endotracheal intubation kit | B |
| 112 | Tracheostomy kit | C |
Types of Licenses Needed for Different Classes of Anaesthesia Medical Devices
According to the notification by CDSCO, manufacturers of class A and B devices need Form MD 5 license for anaesthesia medical devices, while class C and D devices require Form MD 9 license. If you plan to import devices into India, you need Form MD 15 import license.
CDSCO Approval Process for Anaesthesia Medical Devices
The stepwise approval process for obtaining the CDSCO anaesthesia medical devices registration is as follows:
- Check if the device comes under the CDSCO’s notified list. Apply for a No Objection Certificate (NOC) if it doesn’t.
- Foreign manufacturers must appoint an Authorized Indian Agent (IAA). The IAA will handle regulatory correspondence and compliance to import and market anaesthesia medical devices in India.
- Visit the CDSCO’s online Medical Device Sugam portal to submit the application for approval.
- CDSCO will review the application thoroughly. If something is needed from you, the officials will raise a query online.
- Upon satisfactory review, CDSCO anaesthesia medical devices import license will be issued.
- The CDSCO license for anaesthesia medical devices in India is valid for Five years, unless it is suspended or cancelled by the authority.
Documents needed for CDSCO Anaesthesia Medical Devices Registration
The following documents are essential to submit for successful registration of your medical devices.
- Duly filled application form
- Power of Attorney (for foreign manufacturers)
- ISO 13485 Certificate (quality management system)
- Certificate of Quality Assurance
- Plant Master File (PMF)
- Device Master File (DMF)
- CE Certificates (if available)
- Proof of fee payment (Challan TR6)
Challenges Faced by Manufacturers & Importers in CDSCO Anaesthesia Medical Devices Registration
Manufacturers and importers of anaesthesia medical devices in India face several challenges in the CDSCO registration process. These include the need for extensive documentation, the requirement to match documents with detailed technical specifications, and compliance with multiple authorities.
- Technical documents, like Device Master File (DMF) and Plant Master File (PMF), biocompatibility testing reports, risk management reports, and more require a lot of time to gather. The extensive and highly detailed list of documents is often a challenge for both manufacturers and importers.
- Separate fees and applications are required for anaesthesia medical devices under different brand names or with different specifications. If manufacturers and importers are not aware of this, it leads to unwanted costs and administrative burden.
- The registration process is lengthy and can take several months as per the risk class of your device. If additional information or clarifications are needed and you cannot respond to them promptly, it leads to significant delays.
- It is essential to monitor regulatory updates. Inability to keep up with changes in the Medical Devices Rules and CDSCO notifications disrupts a smooth approval process.
Conclusion
CDSCO requires manufacturers and importers to demonstrate that their anaesthesia medical devices are safe, high-performing, and reliable. Through rigorous testing and documentation, the quality of these devices is ascertained and only then they can be marketed in India.
It is here where Dueran Consultant helps you. We provide support and expertise from the beginning till the end and ensure that your devices get approved in the shortest time. We negotiate with regulatory bodies on your behalf and remove the technical complexity needed for compliance with our expert assistance. Connect with us for a hassle-free authorization of your anaesthesia medical devices with minimal cost.
Frequently Asked Questions (FAQ’s)
1. Who needs to register for CDSCO license?
If you are a person or an entity involved in manufacturing, importing, exporting, selling, or doing research related to medical devices.
2. How long does CDSCO anaesthesia medical device registration take?
The timeline varies greatly. It can be as short as 2 to 4 months or as long as 9 to 12 months depending upon class of Medical Devices.
3. How do I get Form MD 15 to import anaesthesia medical devices?
Submit the application in Form MD 14 on the CDSCO online portal along with technical data, performance reports, and compliance certifications as per the prescribed regulatory format. Pay the fee and submit the application.
