In India, quality, safe, and performance of medical devices are regulated under provisions of the Drugs & Cosmetics Act, 1940 & Rules made thereunder. Anesthesiology[1], also known as Anesthesia, is concerned with complete perioperative treatment of patients prior to the surgery. It comprises of anesthesia, critical emergency medicine, thorough care medicine, and pain medicine. From Oct 2022, the said medical devices having risk classes A & B will be covered under Licensing Regime of CDSCO. Once devices are under the ambit of the Licensing Regime of CDSCO, all the Manufacturers & Importers of Anesthesiology Medical Devices will have to apply for CDSCO Registration for Anesthesiology Medical Devices to sell the products into the Indian Market. Scroll down to check more information regarding the CDSCO Registration for Anesthesiology Medical Devices.
A Brief on CDSCO Regulation on Medical Devices in India
CDSCO is National Regulatory Authority of India (NRAI) and is totally responsible for the regulation of Medical Devices, Drugs, and In-Vitro Devices in India. It works under the Ministry of Health & Family Welfare which the Directorate General of Health Services regulates under the Government of India.
In India, a medical device is categorised into 2 different categories:
- Non-Notified Medical Devices
- Notified Medical Devices
The MDR, 2017 were brought into effect on Jan 2018 by the Central Drugs Standard Control Organisation. The CDSCO categorises medical devices into 4 different classes i.e., Class A, B, C & D. Under this classification, Medical Devices are categorised based on risks involved. The different classes of devices involve different licensing requirements & procedures.
| Class | Risk-Type |
| Class A | Low |
| Class B | Low-Moderate Risk |
| Class C | Moderate-High Risk |
| Class D | High-Risk |
Classification of Anesthesiology Medical Devices
The Anesthesiology category consists of a total of 115 Medical Devices, which are categorised on the basis of their risk class & intended use. Out of which, only Class A & B Medical Devices will fall under Licensing Regime from 1st October 2022. Following is the list of medical devices:
| Name of Medical Devices | Class |
| Aerosol Delivery Tubing | A |
| Aerosol Face Mask | B |
| Aerosol Inhalation Monitor | B |
| Airway Device Cleaning Utensil | A |
| Airway pressure alarm | A |
| Airway protection face mask | A |
| Airway Temperature Monitoring System | B |
| Airway Tube Forceps | A |
| Anesthesia Breathing Circuit | B |
| Anesthesia Catheter Luer Connector | A |
| Anesthesia Depth Monitor | B |
| Anesthesia Depth Simulator | A |
| Anesthesia Information System | B |
| Anesthesia Mask Stabiliser | A |
| Anesthesia System Leakage Tester | A |
| Anesthesia Warmer | A |
| Anesthesia Workstation Gas Scavenger | B |
| Anesthesia Gas Absorption or Desorption Device | B |
| Anesthesia Gas Scavenging Terminal Unit | A |
| Anesthesia Face Mask | A |
| Artificial Airway Stylet | A |
| Artificial Airway Washing or Disinfection Jar | B |
| Atomiser | A |
| Brachial Plexus Anesthesia Kit | B |
| Breathing Circuit Bag | A |
| Breathing Circuit Condenser | A |
| Breathing Circuit Dryer | A |
| Breathing Circuit gas-sampling or Monitoring Set | B |
| Breathing Circuit Washer or Disinfector | B |
| Breathing Mouthpiece | A |
| Bronchial Cannula | A |
| Bronchoscope | A |
| Bronchoscopy Tube | B |
| Bulk Oxygen Concentration System | A |
| Capnography Oxygen Mask | A |
| Capnography Sampling Adaptor | A |
| CPAP or BPAP Nasal Mask | B |
| CPAP or BPAP Oral Mask | B |
| Electronic Oesophageal Stethoscope | B |
| Endobronchial Airway Sizing Kit | A |
| Endobronchial Tube | B |
| Endotracheal Secretion Monitoring System | B |
| Helium or Oxygen Breathing Gas Mixer | B |
| Inhalational Analgesia Unit | B |
| In-Line Arterial Blood Sampling Set | A |
| In-Line Backflow Valve | A |
| Intracardiac Oximeter | B |
| Intravascular Blood Gas or pH Monitoring System | B |
| Intravascular Membrane Oxygenator | C |
| Intravascular Oximeter | B |
| Intubation Laryngoscope | A |
| Intubation Teeth Protector | A |
| Invasive Arterial Pressure Cardiac Output or Oximetry Monitor | B |
| Laryngeal Airway | A |
| Laryngeal Airway Introducer | A |
| Laryngectomy Tube | B |
| Laryngotracheal Anesthesia Applicator | B |
| Mechanical Positive Pressure Airway Secretion-Clearing Device | A |
| Medical Gas Flowmeter | A |
| Medical Gas Flowmeter, Thorpe Tube | A |
| Medical Gas Pipeline System | A |
| Medical Gas Pipeline System Automatic Outlet Analyser | A |
| Medical Gas Pipeline System Pressure Monitor | A |
| Medical Gas Terminal Unit | A |
| Medicine Chamber Spacer | B |
| Microbial Medical Gas Filter | B |
| Nasopharyngeal Airway | A |
| Neonatal Chest Percussor | B |
| Nerve-Block Injection Manometer | A |
| Nitric Oxide Delivery Unit | B |
| Non-Heated Respiratory Humidifier | B |
| Non-Rebreathing Oxygen Face Mask | A |
| Nose Clip | A |
| Oropharyngeal Airway | A |
| Oxygen Administration Hood | A |
| Oxygen Saturation or Pulse Rate Simulator | A |
| Oxygen or Air-Breathing Gas Mixer | B |
| Peak Flow Meter | B |
| Pleural Manometer | B |
| Pneumatic Chest Percussor | B |
| Pressure Algometer or Aesthesiometer | B |
| Pulmonary Function Analysis System | B |
| Pulse Co-oximeter | B |
| Rebreathing Oxygen Face Mask | A |
| Respiration Monitor | B |
| Respiratory Oxygen Monitor | B |
| Respiratory Oxygen Therapy Monitor or Regulatory | B |
| Retrograde Endotracheal Intubation Kit | B |
| Rigid Non-Bladed Video Intubation Laryngoscope | A |
| Saddle Block Anesthesia kit | B |
| Spirometer or Pulmonary | A |
| Function Analyser Syringe | A |
| Tracheal Surgery Dilator | A |
| Tracheostomy Tube Cannula | A |
| Tracheotome | A |
| Ultrasonic Cough Stimulation System | A |
| Ultrasonic Respiratory Humidifier | B |
| Vacuum Assisted Airway Secretion Clearing System | B |
| Venturi Oxygen Face Mask | B |
| Vortex Oxygen Face Mask | B |
| Anaesthesia Instrument Table | A |
List of Documents Required for CDSCO Registration for Anesthesiology Medical Devices in India
Following is the list of all the vital documents required for CDSCO Registration for Anesthesiology Medical Devices in India:
- Duly filled application form for CDSCO Registration for Anesthesiology Medical Devices in India;
- Power of Attorney;
- ISO 13485;
- Certificate of Quality Assurance;
- Master Plant File (MPF);
- Device Master File (DMF);
- Either an FSC/Free Sale Certificate or Certificate from Foreign Government;
- C.E. Quality Assurance;
- Declaration of Conformity;
- C.E. Design Accreditation;
- Challan TR6.
Procedure for CDSCO Registration for Anesthesiology Medical Devices in India
Following is the step-by-step procedure for CDSCO Registration for Anesthesiology Medical Devices in India:
Step 1: Identify whether the medical devices are under Notified List or Not: The CDSCO has provided a detailed list of Notified Medical Devices that need to get Registration under the Drugs & Cosmetics Act compulsorily, 1940 and as per the MDR, 2017. However, there may be any medical devices that haven’t been expressly notified by the CDSCO, on in the case of new medical devices, the importer or manufacturer shall be required to get a NOC (No Objection Certificate) in such cases.
Step 2: Appoint an Authorised Representative (For Foreign Entity): For a Foreign Manufacturer or Entity, it is vital to appoint an authorised business entity or representative in India, who shall be the contact individual for the inspection authorities at the time of the process, help in device approvals, and Registration Process, and vigilance adverse event reporting.
Step 3: Filing Application form: In this step, the Manufacturer or Importer of Medical Devices shall be required to submit the application form along with the documents and prescribed fees on the CDSCO website to the DGCI.
Step 4: Obtain Certificate of CDSCO Registration for Anesthesiology Medical Devices in Prescribed Form: Once the application form is submitted, then the authority may send a query via an inquiry letter to the Manufacturer or Authorised Representative of the importer along with the prescribed timeline within which the query or any question should be answered. On satisfactory, the authority may issue a License. After Registration, the Manufacturer or their Authorised Representative may apply for an Importer License.
Note: Once obtained, the Certificate of CDSCO Registration for Anesthesiology Medical Devices in India shall be valid for 3 years from date of issance of the Registration Certificate unless cancelled or suspended by the DGCI Authority for proper causes.
Post-Compliance After Getting Registration Certificate
- In case of any change that has taken place regarding the constitution of the firm and/or address of registered office or factory premises, the Medical Devices Manufacturer or Authorised Representative of the Importer is to intimate the Licensing Authority regarding same in writing;
- In case any such change has taken place, existing Registration Certificate shall be valid for a maximum period of 3 months from the date on which the change has taken place and at this time, the Authorised Representative shall be required to get Fresh Registration Certificate.
Conclusion
The CDSCO has issued a new risk-based classification for Anesthesiology Medical Devices in India must follow the latest medical equipment rules in India. The notice was issued by the CDSCO, which listed that Anesthesiology Medical Devices are to be categorised as Non-Notified Medical Devices by CDSCO. The classification includes 115 Medical Devices.
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