A brief introduction of Anesthesiology
The medical field of anesthesiology, sometimes known as anesthesia, is concerned with the complete perioperative treatment of patients prior to, during, and the following surgery. It includes anesthesia, critical emergency medicine, intensive care medicine, and pain medicine. Depending on the nation, a doctor who specializes in anesthesiology is referred to as an anesthesiologist, anesthetist, or anesthesiologist. The names are interchangeable in certain countries, but they relate to separate jobs in others, and the term "anesthetist" is only applied to non-physicians like nurse anesthetists.
Table of Contents
- A brief introduction of Anesthesiology
- What is a Medical Device?
- Types of Medical Devices in India-
- Eligibility Criteria for Medical Devices Registration/Import
- Process & Fee for Medical Devices Registration
- Documents required to be attached
- Time Involved &Validity for Registration
- Re-registration or Renewal of the Registration Certificate
- Post-Compliances after receiving registration-
- How to Register any new /Additional Medical Device if Medical Device Registration Obtained Already?
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From the 1st of October 2022, the said medical devices having risk classes A and B will be covered under the licensing regime of CDSCO. Once the devices are under the scope of the licensing regime of CDSCO, all the importers and manufacturers of the said devices will have to apply for the license in order to sell their products in Indian Market.
The Anesthesiology category consists of a total of 115 medical devices which are classified on the basis of their risk class and intended use. Out of which only class A and class B medical devices will fall under the licensing regime from 1 October 2022. The CDSCO listed medical devices are as below mentioned
|S. No.||MEDICAL DEVICE NAME||INTENDED USE||CLASS|
|1||Aerosol delivery tubing||A flexible tube used in conjunction with an oxygen mask, endotracheal (ET) tube, humidifier, or nebulizer, intended for the delivery of aerosolized humidification, typically oxygen enriched.||A|
|2||Aerosol face mask||A flexible, form-shaped device that is placed over the nose and mouth to deliver air, oxygen (O2), or a mixture of the two gases, with aerosolized particles, to a patient's airway.||B|
|3||Aerosol inhalation monitor||It is a device that enables a medical professional to objectively assess in detail how the test subject uses their inhaler.||B|
|4||Airway device cleaning utensil||A hand-held device intended to be used to clean an in situ and ex situ airway device.||A|
|5||Airway pressure alarm||A device connected to the breathing circuit monitors a patient's upper airway pressure during assisted mechanical ventilation.||A|
|6||Airway protection face mask||A flexible, form-shaped device that is placed over the nose and mouth to provide respiratory protection.||A|
|7||Airway temperature monitoring system||An assembly of devices is used to continuously measure the temperature at a specific point along a ventilation airway.||B|
|8||Airway tube forceps||A hand-held instrument is used for grasping a tube for its insertion and/or extraction into/from the airways, or for grasping obstructive objects for their removal from the airways.||A|
|9||Anesthesia breathing circuit||An assembly of devices designed to conduct medical gases from the fresh gas supply outlet of an anesthesia unit/workstation to the patient.||B|
|10||Anaesthesia catheter Luer connector||It is a device intended to create a mechanical union between an anesthesia catheter and an external device, via a Luer connection.||A|
|11||Anaesthesia depth monitor||It is a device intended to be used to detect, process, and display the signals recorded from an unconscious patient (in a state of anaesthesia), showing the degree of consciousness.||B|
|12||Anesthesia depth simulator||A device intended to simulate the electroencephalography (EEG) signals of an unconscious patient (in a state of anaesthesia) in order to test and calibrate an anaesthesia depth monitor, check patient cable continuity, or train healthcare providers.||A|
|13||Anesthesia information system||A dedicated assembly of devices designed to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of anaesthesia services.||B|
|14||Anaesthesia instrument table||It is intended as a support for Anaesthesia instruments used during general anaesthesia surgical procedures.||A|
|15||Anaesthesia mask stabilizer||A device intended to secure an anaesthesia mask on the face of a patient typically by providing anchorage for the fixation of the mask's headstrap.||A|
|16||Anaesthesia system leakage tester||A device intended to test an anaesthesia system for leakage.||A|
|17||Anaesthesia warmer||A device intended to warm the anaesthetic solutions prior to it being administered to a patient for anaesthesia.||A|
|18||Anaesthesia workstation gas scavenger||A device intended to connect between the expiratory valve/port of a breathing circuit and the extraction system enabling the waste anaesthetic, exhaled, or other trace gases to be removed under controlled conditions from the work environment and channelled to the outside of the building.||B|
|19||Anaesthetic gas absorption/desorption device||A device intended to, when integrated within the common line of a breathing circuit, absorb and desorb (i.e., recycle) exhaled volatile anaesthetic agents.||B|
|20||Anaesthetic gas scavenging terminal unit||A device intended to function as an outlet assembly to which the operator can connect/disconnect an anaesthetic gas scavenging system (AGSS).||A|
|21||Anesthesia Face Mask||A device designed to be placed over a patient's nose and/or mouth to administer anaesthetic gases to the upper airway.||A|
|22||Artificial airway stylet||A device intended for insertion within the lumen of an artificial airway tube to stiffen and/or maintain the shape of the tube to facilitate intubation.||A|
|23||Artificial airway washing/disinfection jar||A container intended to hold artificial airway devices to facilitate their washing/disinfection.||B|
|24||Atomizer||A device that is intended to provide liquid medication in aerosolized form into the air that a patient will breathe.||A|
|25||Brachial plexus anaesthesia kit||A collection of devices intended to deliver a brachial plexus nerve block through one of several routes that could include supraclavicular, interscalene, infraclavicular, or axillary.||B|
|26||Breathing circuit bag||A device intended to store breathing gas during the respiratory cycle.||A|
|27||Breathing circuit condenser||A device intended to be integrated within the expiratory limb of a breathing circuit to remove excess moisture through cooling and condensing, whilst also reheating the dried gases to an appropriate machine-compatible temperature.||A|
|28||Breathing circuit dryer||A device that is used for the purpose of drying breathing circuit equipment that have been washed inorder to prevent bacteria growth and deterioration.||A|
|29||Breathing circuit gas- sampling/monitoring set||A collection of devices intended to be integrated within a breathing circuit to enable interface of gases between the breathing circuit and a respiratory monitoring device for sampling the patient's expired gas for measurements of pressure, flow and/or gas analysis.||B|
|30||Breathing circuit washer/disinfector||A device intended for the cleaning and high-level disinfection of breathing circuit components used in respiratory therapy and anaesthesia equipment.||B|
|31||Breathing mouthpiece||A device intended to be inserted into a patient's mouth to facilitate access to the respiratory system.||A|
|32||Bronchial cannula||A tube-shaped surgical instrument that is inserted into the lumen of the bronchus by means of a trocar blade to provide rigidity.||A|
|33||Bronchoscope||An endoscope with an inserted portion intended for the visual examination and treatment of the trachea, primary bronchi, and upper regions of the lungs and take biopsies and sample of secretions.||A|
|34||Bronchoscopy tube||A device which is inserted orally into the trachea to maintain airway patency and/or to deliver anaesthetic inhalation agents or other medical gases, and secure ventilation during diagnostic or therapeutic bronchoscopy using a flexible bronchoscope.||B|
|35||Bulk oxygen concentration system||An assembly of devices designed to concentrate oxygen (O2) from ambient air and then deliver the concentrated O2, with purity of up to 99.5%, to the hospital medical gas supply system.||A|
|36||Capnography oxygen mask||A device intended to be placed over the nose and mouth to deliver oxygen (O2) to a patient's airway and to sample exhaled respiratory gases for monitoring the patient’s ventilatory status.||A|
|37||Capnography sampling adaptor||The device is intended for sampling CO2 and use with monitors enabled with capnography technology.||A|
|38||CPAP/BPAP nasal mask||A device designed to be placed over a user's nose to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for non-invasive positive pressure ventilation (NPPV).||B|
|39||CPAP/BPAP oral mask||A device designed to be fitted to the user's mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for non-invasive positive pressure ventilation (NPPV).||B|
|40||Electronic oesophageal stethoscope||An electronic listening device designed to be inserted into a patient's oesophagus to listen to heart and breathe sounds, typically while the patient is under anesthesia.||B|
|41||Endobronchial airway sizing kit||A collection of mechanical devices intended to be used with a balloon catheter for a planned intervention to determine the appropriate endobronchial valve sizes for a patient's lung airways (bronchial lumens).||A|
|42||Endobronchial tube||A hollow cylinder that is designed for oral insertion via the trachea and into a lung to maintain airway patency and/or to deliver anesthetic inhalation agents or other medical gases, and secure ventilation.||B|
|43||Endotracheal secretion monitoring system||An assembly of devices designed to continuously detect the sound of endotracheal (ET) secretions moving through a ventilation circuit during suctioning of an artificially ventilated and/or spontaneously breathing patient to assess the effectiveness of suctioning.||B|
|44||Helium/oxygen breathing gas mixer||An independent mechanical device designed for accurate mixing of helium (He) and oxygen (O2) with concentrations that are appropriate for breathing in a patient who is indicated to assist the flow of O2 into the alveoli and to reduce the work of breathing.||B|
|45||Inhalational analgesia unit||A device primarily designed to administer analgesic gases to the patient, or produce analgesia vapors for inhalation.||B|
|46||In-line arterial blood sampling set||A collection of devices designed to obtain an in-line arterial blood specimen while maintaining a closed system.||A|
|47||In-line backflow valve||A general-purpose device used in medical tubing or pipe lines to prevent the backflow of gases or liquids.||A|
|48||Intracardiac oximeter||A photoelectric device designed to transmit radiation at a known wavelength(s) through the blood to measure the concentration of oxygen, or dye, within the heart based on the amount of reflected or scattered radiation.||B|
|49||Intravascular blood gas/pH monitoring system||An assembly of devices used for the continuous in vivo measurement and display of the values of pH and/or the partial pressure of CO2 and/or O2 in arterial blood. The system is used for patients with respiratory failure or severe pulmonary hypertension after cardiac surgery.||B|
|50||Intravascular membrane oxygenator||A device designed for intravascular diffusion of oxygen into and carbon dioxide from the blood across an implantable (vena cava) gas-permeable membrane, used mainly as a temporary treatment for failing lungs in adults with respiratory distress syndrome.||C|
|51||Intravascular oximeter||An instrument designed for the continuous in vivo measurement of venous blood oxygen saturation (SvO2) using a fibreoptic catheter.||B|
|52||Intubation laryngoscope||A hand-held device intended to be used by anesthesia/emergency service personnel to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anesthesia and/or ventilation.||A|
|53||Intubation teeth protector||A device designed to fit over the upper and lower sets of teeth to protect them from damage during endotracheal (ET) tube intubation procedures.||A|
|54||Invasive arterial pressure cardiac output/oximetry monitor||A device intended to continuously measure and display arterial pressure cardiac output (APCO) and hemoglobin oxygen saturation (e.g., SpO2) when connected to an extravascular blood pressure transducer linked to a peripheral arterial line, and to a pulse oximeter or an oximetry catheter.||B|
|55||Laryngeal airway||A curved tube is used in inhalational anesthesia and resuscitation to facilitate and secure airway patency for the delivery and exchange of gases in spontaneously breathing and ventilated patients.||A|
|56||Laryngeal airway introducer||A device intended to aid the insertion of a laryngeal airway into the pharyngeal cavity of a patient while reducing or eliminating the need for finger manipulation within the mouth. It is typically in the form of a metal blade with a handle and may be mounted onto the laryngeal airway during insertion. This is a reusable device intended to be sterilized prior to use.||A|
|57||Laryngectomy tube||A device intended to maintain tracheostomy patency after laryngectomy to provide an airway for the patient and to prevent tracheostomy stenosis in the months following the procedure.||B|
|58||Laryngotracheal anesthesia applicator||A non-sterile container that is prefilled with an anaesthetic agent and intended to be used to apply the agent to the oropharynx and upper airway, to relax laryngotracheal reflexes prior to an intervention of an endotracheal (ET) tube or another type of tracheal tube.||B|
|59||Mechanical positive pressure airway secretion-clearing device||A hand-held, mechanical device designed to remove excessive mucus or sputum (phlegm) from the lungs and upper airway of a patient typically suffering from acute or chronic lung disease.||A|
|60||Medical gas flowmeter||A device intended to measure and regulate the flow of a medical gas during various procedures.||A|
|61||Medical gas flowmeter, Thorpe tube||A device intended to measure and regulate the flow of a medical gas during various procedures.||A|
|62||Medical gas pipeline system||An assembly of devices designed to supply compressed medical gases from a central source to endpoints throughout a medical facility.||A|
|63||Medical gas pipeline system automatic outlet analyzer||A main component of a medical gas pipeline supply system that monitors the composition of a gas delivered from the supply system.||A|
|64||Medical gas pipeline system pressure monitor||A component of a medical gas pipeline system designed to continuously monitor and detect changes in the pressure values of the medical gases in the supply pipeline.||A|
|65||Medical gas terminal unit||A device that is a component of a medical gas pipeline system or a medical gas/vacuum pipeline system that has a gas-specific outlet connection for a single/mixture of gas to which the operator can connect and disconnect a medical device.||A|
|66||Medicine chamber spacer||A device intended to be placed between a nebulizer or a metered dose inhaler (MDI) and the patient's mouth, to function as a reservoir into which an aerosol medication is dispensed in order to minimize delivery of large aerosolized particles.||B|
|67||Microbial medical gas filter||A screening device intended to remove microbes from medical gases to prevent patient exposure during respiration, anesthesia, and/or endoscopy.||B|
|68||Nasopharyngeal airway||A rubber or plastic tube that extends into the pharynx from either naris to maintain airway patency.||A|
|69||Neonatal chest percussor||A hand-held device (a percussor) intended to be operated by a healthcare professional to provide external vibrations to the chest wall of a neonate to help loosen bronchial mucus for expectoration through suctioning. It is used to help loosen secretion build-up in the lungs of neonates who cannot perform the natural cough mechanism.||B|
|70||Nerve-block injection manometer||A non-invasive device intended to be connected between a syringe and a nerve-block needle to indicate injection pressure during administration of local or regional anesthesia to achieve peripheral nerve blockade.||A|
|71||Nitric oxide delivery unit||A device intended for the delivery of precise amounts of nitric oxide (NO), also known as nitrogen monoxide, to the respiratory tract of neonate, pediatric, and adult patients to treat severe respiratory disorders.||B|
|72||Non-heated respiratory humidifier||A device designed to prevent the drying of airway passages associated with the inhalation of oxygen (O2) by adding water vapor to the dry gas as it is passed through, or more seldom, over water.||B|
|73||Non-rebreathing oxygen face mask||A flexible, form-shaped device designed with valve to control rebreathing and contamination of gas, placed over the nose and mouth to deliver air of high oxygen (O2) concentration to a patient's airway for oxygen therapy.||A|
|74||Nose clip||A device intended to be used to compress the nose externally, to ensure that airflow is exclusively conducted through the mouth during examinations of the pulmonary function, and/or to stop nosebleeds.||A|
|75||Oropharyngeal airway||A curved metal or plastic tube is inserted through the mouth to facilitate airway patency for gas exchange or suctioning. The device prevents the tongue from obstructing airflow.||A|
|76||Oxygen administration hood||A device consisting of a rigid transparent plastic shell forming an enclosure over the head of an adult, typically to provide an enriched oxygen (O2) environment to increase the patient's O2 uptake.||A|
|77||Oxygen saturation/pulse rate simulator||An electronic instrument designed to simulate arterial oxygen saturation and/or pulse rate for testing and calibrating pulse oximeters, pulse oximeter probes, and other related pulse oximetry devices.||A|
|78||Oxygen/air-breathing gas mixer||A portable mechanical device designed to mix air and oxygen (O2) for mobile O2 administration during first aid or emergency situations.||B|
|79||Peak flow meter||A device designed to measure the maximum rate of expiratory gas flow [peak expiratory flow (PEF) or peak expiratory flow rate (PEFR)] and forced expiratory volume (FEV) from the lungs. The device is typically intended to monitor the respiratory status of a patient suffering from chronic respiratory disease in a clinical setting or the home.||B|
|80||Pleural manometer||A non-invasive device intended to convert pressure into electrical signals for the measurement of pressure within the pleural cavity.||B|
|81||Pneumatic chest percussor||A hand-held pneumatic device designed to provide external vibrations to the chest wall of a patient to loosen excessive airway secretions to promote airway clearance and improve bronchial drainage for patients with respiratory disease.||B|
|82||Pressure algometer/aesthesiometer||An instrument designed to measure a patient's sensitivity to pain (pain threshold) and tactile sensibility.||B|
|83||Pulmonary function analysis system||A device used to measure the function of the respiratory system in adults and compliant children.||B|
|84||Pulse Co-oximeter||A device designed to detect hypoxia via the transcutaneous multiwire measurement and display of carboxy- hemoglobin saturation (SpCO) and typically other related parameters such as hemoglobin oxygen saturation (SpO2), methemoglobin saturation (SpMet), and hemoglobin concentration (SpHb).||B|
|85||Rebreathing oxygen face mask||A flexible, form-shaped device designed to be placed over the nose and mouth to deliver a proportional mixture of air/oxygen (O2) to a patient's airway.||A|
|86||Respiration monitor||A device designed to measure and display a non-ambulatory patient's respiratory functions. Measurements include the concentration of respiratory gas components and/or continuous monitoring of the inspiration/expiration cycle including respiration rate, air volume, and cessation of breathing (apnoea).||B|
|87||Respiratory oxygen monitor||An instrument designed to continuously measure the concentration of oxygen (O2) inspired by a patient in a respiratory maintenance/therapy setting.||B|
|88||Respiratory oxygen therapy monitor/regulator||An electrically-powered unit designed to be connected to a pulse oximeter sensor and used during the administration of oxygen (O2) to a spontaneously breathing patient, for 1) continuous monitoring of physiologic parameters, especially hemoglobin oxygen saturation (SpO2); and 2) dynamic regulation of the amount of O2 delivered to the patient based on physiological parameter measurements.||B|
|89||Retrograde endotracheal intubation kit||A collection of devices used to assist in the placement of an endotracheal (ET) tube during difficult/emergency airway access procedures.||B|
|90||Rigid non-bladed video intubation laryngoscope||A non-sterile device intended to facilitate the positioning of an endotracheal (ET) tube prior to the delivery of inhalation anesthesia and/or ventilation.||A|
|91||Saddle block anesthesia kit||A collection of devices designed to deliver an analgesic or anesthetic agent to the lower dural sac in the region corresponding to the buttocks, in the perineum, or to the inner aspects of the thighs.||B|
|92||Spirometer/pulmonary function analyser syringe||A device consisting of a barrel (cylinder) with plunger/piston intended to be used for injecting small volumes of accurately measured amounts of gas into a spirometer, pulmonary function analyzer, or other diagnostic pulmonary measuring/testing device for calibration or reference.||A|
|93||Tracheal surgery dilator||A hand-held manual surgical instrument intended to be used during the surgical intervention of the trachea to dilate tracheal structures/passages, typically during the creation of a tracheostomy and/or for expanding the margins of a tracheostomy to assist in the insertion of a tracheostomy tube.||A|
|94||Tracheostomy tube cannula||A hollow, cylindrical, curved device designed as an internal, independent component of a metal tracheostomy tube. It is removed once or more times daily to facilitate the removal of phlegm, slime, and contamination build-up, thereby preventing blockage and infection of the stoma and eliminating the traumatic removal of the tracheostomy tube.||A|
|95||Tracheotome||A surgical instrument designed to cut an opening into the trachea (windpipe) through the anterior surface of the neck to create an artificial airway (tracheotomy).||A|
|96||Ultrasonic cough stimulation system||An assembly of devices designed to stimulate a reflex cough using ultrasound in a patient who cannot cough on command, typically respiratory patients with cortical insufficiency or the very young/elderly, to help clear the lungs of secretions and aspirated materials.||A|
|97||Ultrasonic respiratory humidifier||A device designed to agitate water into micro-particles with ultrasound to add moisture to the flow of air/gases administered to a patient via a breathing tube/circuit.||B|
|98||Vacuum-assisted airway secretion-clearing system||A device assembly designed to remove excessive secretion from the lungs and upper airway of patients with respiratory disease or during cardiac rehabilitation through vacuum technology.||B|
|99||Venturi oxygen face mask||A flexible, cone-shaped device is placed over the patient's nose and mouth to deliver a mixture of an almost precise ratio of air and oxygen to the patient's airway. The device usually has a replaceable part (Venturi tube) to change the mixture ratio of air and oxygen so that oxygen is delivered at the desired concentration. The device is connected to the oxygen source via a tube. The device has a head strap for fixation. Normally comes with an adapter to connect with a humidifier.||B|
|100||Vortex oxygen face mask||A device designed to be placed over the nose and mouth of a patient to deliver a near-precise mixture of air and oxygen (O2) to a patient's airway without the use of a gas mixer.||B|
Central Drugs Standard Control Organisation:
India is growing as one of the nation's leading in the pharmaceutical business and is among the top ten nations in terms of the pharmaceutical industry. Several factors such as the large population, growing health awareness, affordable medical facilities, and better research facilities have given rise to the manufacturing and development of pharma business in India. However, with the increasing scope for the growth of the pharma industry in India, there are possibilities for the sale/purchase of medical equipment & device illegally or without jurisdiction. Therefore, the Government of India has established the Central Drug Standards Control Organization (CDSCO), which is the primary legislative body and has been responsible for the regulation, control, and management of pharmaceuticals and medical devices in India apart from the appointment of the Drug Controller General of India (DCGI), and has conferred the responsibility of undertaking assessment, approval and regulation of further compliances(import, export, sale, distribution) in the matters of medicinal drugs and medical devices(including any existing or any new) drugs/devices in accordance with the provisions of the Drugs and Cosmetics Act 1940.
Consequently, To date, about 37 categories of medical devices have been regulated or notified as drugs under the Drugs & Cosmetics 1940. While the notified medical devices/equipment need to obtain registration for their manufacture or import in India, the medical devices that are not recognized need to obtain a NOC from the CDSCO.
What is a Medical Device?
According to the latest definition as provided under the Medical Devices Amendment rules 2020, as notified on 11.02.2020. However, taking care of circumstances the government has exercised its powers to include more categories by widening the scope of the definition of “Medical Device” under the Act. It states-
"Devices used in general medical practice such as medical apparatus, instruments, implants appliance, etc., which are either used individually or in combination, and are intended to be specifically applied for human beings or animals and are further intended to obtain the desired function by such means and for such purposes as provided below, but is not intended to meet the primary intended action on human body or animals by any pharmacological or immunological or metabolic means-
- Analysis, prevention, observing, treatment, or mitigation of any disease or disorder;
- Analysis, observing, treatment, mitigation, or support for any injury or disability;
- Examination, replacement or alteration, or support in findings of the anatomy or a physiological process;
- For supporting or sustaining life;
- Decontamination of medical devices; and
- Conception-related equipment & devices.
Therefore, every manufacturer or importer or both of any medical devices in India shall be required to obtain registration as per the provisions of the Drugs and Cosmetics Act 1940. Any failure to comply with the same may invite legal action including penalty & prosecution under the Act.
Types of Medical Devices in India-
Provisions related to the import, manufacture, sale & distribution of medical devices are regulated under the provisions of the drug and cosmetics Act 1945. Under the New Medical Rules 2017, all medical devices have been classified into four different categories depending on their usability & risk involved as provided below.
- Class A: Low-risk devices like a thermometer, tongue depressors, etc.
- Class B: Low moderate risk like Hypodermic Needles, suction equipment, etc.
- Class C: Moderate high-risk devices like Lung ventilators, etc.
- Class D: High-risk devices like Heart valves, implantable devices, etc.
Where Class A & B devices are considered to be less risky and moderate devices, for which the application to manufacture has to be filed to the State Licensing Authority. Whereas Class C &D are considered to be high and very High-risk devices and the application for these has to be filed to the Central Licensing Authority of India.
Eligibility Criteria for Medical Devices Registration/Import
The provisions related to activities such as Import, manufacture, sale and distribution of medical devices have been regulated under the provisions of the Drugs & Cosmetic Act 1940 & Rules 1945. Therefore, any person/firm/enterprise, etc. holding a wholesale drug license and/or manufacturing license issued under the Drugs and Cosmetics Act, 1940 and Rules 1945 could make an application for Registration and import of medical devices into India.
Process & Fee for Medical Devices Registration
Types of Medical Devices Registration
- Registration/Import of any existing medical device;
- Registration /import of any new medical device
Step 1: Determine whether your medical device is under notified list or not
The CDSCO authority has provided a list of notified medical devices that need to compulsorily obtain registration under the Drugs and Cosmetics Act 1940 and in accordance with Medical devices rules 2017. However, there may be any medical devices that have not been expressly notified by the CDSCO authority, or in the case of new medical equipment, the manufacturer/importer shall be required to obtain a NOC in such cases. For instance, Blood Grouping Sera Ligatures, Sutures, Staples Intra-Uterine Devices (Cu-T), Condoms, Tubal Rings, Surgical Dressing, Umbilical Tapes, Blood / Blood Component Bags do not need registration, whereas devices such as spinal needles, cochlear implants, syringes, and needles, heart valves, endotracheal tubes and catheters among others should undergo registration provides with the CDSCO.
Step 2: Appoint an Authorized representative (in case of a Foreign Entity)
For a foreign business manufacturer entity, it shall be necessary to appoint an authorized business entity in India, who shall be the contact person for the inspection authorities during the process, assist in device approvals, and registrations process, and vigilance adverse event reporting. The Indian Authorization should hold a wholesale drug license in forms 20B& 21B.
Step 3: Fill out the application form for Medical Device Registration
In the next step, the manufacturer/importer for MD shall be required to submit the registration form of a regulatory dossier, along with all the prescribed documents along with the prescribed fee on the CDSCO portal to the DGCI (Drugs Controller General of India) by logging on to the online CDSCO portal https://cdsco.gov.in/opencms/opencms/en/Home/ and signing into the portal.
Following forms along with applicable govt. fees have been provided below, which shall be required to be paid through payment challan-
|Applicant Type||Class of MD||Application Form||License Form|
|Manufacturer(Loan License)||A B||MD-4||MD-6|
|Manufacturer(Loan License)||C, D||MD-8||MD-10|
However, in the case of new equipment or medical device-
|Application Type||Class of MD||Application Form||License Form|
|Importer Clinical Investigation||A,B,C,D||MD-22||MD-23|
|Test License(for importer)||A,B,C,D||MD-16||MD-17|
|Manufacturer (Clinical investigation)||A,B,C,D||MD-22||MD-23|
Further, each application shall be supported with the list of documents and the requisite fee as provided in the online portal of CDSCO-
|Type of License||Class of Device||Applicable Regulation||Govt. fee|
For Manufacturing/Loan License
|A or B;||20(2)||Rs. 5000
For Manufacturing/Loan License
|C or D;||21(2)||Rs. 50,000
For Import License(other than IVD)
|Class A||34(2)||1000 Dollar
Import License(other than IVD)
|Class B||34(2)||2000 Dollar
Import License (in IVD)
|Class A or B||34(2)||Rs. 1000
Import License (other than IVD)
|Class C or D||34(2)||3000 Dollar
Import License(in IVD)
|C or D||34(2)||3000 Dollar
Step 4:Obtain Certificate of Registration in Prescribed form
Once the application is submitted on the CDSCO portal, the DGCI registration authority may send a query through an inquiry letter to the manufacturer or from the authorized representative of the importer, along with the timeline within which the query should be answered, and sometimes, may also ask for a technical presentation On satisfaction the authority may issue a license in such form as provided in the above list. After obtaining registration, the manufacturer or his authorized representative may apply for an importer license.
Documents required to be attached
- Form 40
- ISO 13485 certificate
- Full Quality Assurance Certificate
- CE Design Certificate
- Undertaking that all information provided is authentic
- Either a Free Sale Certificate or Certificate from the Foreign Government
- Certificate of Marketability from GHTF (Australia, Canada, Japan, the European Union, and the United States);
- Plant Master Report
- Device Master File
Time Involved &Validity for Registration
If the DGCI doesn’t ask for a Technical Presentation or Subject Expert Committee (SEC) audit, it takes around 6-9 months to obtain a Medical Devices Registration. In cases where Technical Presentation or Subject Expert Committee (SEC) audit, is required, it may take additional 3-6 months.
Once obtained the Registration Certificate shall be valid for a total period of 3 years from the date of issue of registration unless suspended or canceled by the DGCI authority for proper causes.
Re-registration or Renewal of the Registration Certificate
The application for renewal of the MD registration certificate shall be made at least nine months from the expiry of the registration certificate. Though there are no additional requirements for the renewal of registration, it shall be necessary for the certificate holder to provide a copy of the Plant Master File (PMF) and Device Master File (DMF), where there are no changes in the PMF and DMF,
Post-Compliances after receiving registration-
Though there are not many compliances in place about the registration certificate, it shall be compulsory for the certificate holder to-
- In case of any change that has taken place about the constitution of the firm and/or address of the registered office/factory premises, the MD manufacturer/authorized representative of the importer to intimate the licensing authority regarding the same in writing;
- In case any such change has taken place, the existing registration certificate shall be valid for a maximum period of three months from the date on which the change has taken place, and during this time, the manufacturer/authorized representative shall be required to obtain a fresh Registration Certificate;
How to Register any new /Additional Medical Device if Medical Device Registration Obtained Already?
In case an importer wants to obtain registration for manufacturing of any additional manufacturing device, then such person shall be required to obtain an endorsement to the existing Registration Certificate along with the prescribed documents holding that manufacturing of an additional device is being undertaken in the manufacturing site as provided in the registration certificate along with a fee of 1000 dollars fee for each additional device.
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