A Brief Introduction of General Hospital
General hospitals can provide academic health facilities or they can be even community-based. They can be general as they take up a diversity of cases whether it is medical or surgical whereas community-general hospitals vary in the number of beds. Every general hospital has an organized medical staff, a professional staff consisting of nurses, dietitians, physiotherapists, and basic diagnostic equipment.
Table of Contents
- A Brief Introduction of General Hospital
- 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 1st of October 2022, the said medical devices having risk class 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 General hospital category consists of total 52 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
|General Hospital Medical Devices|
|S. No.||Device Name||Inteded Use||India|
|1||Liquid crystal forehead temperature strip||A liquid crystal forehead temperature strip is a device applied to the forehead that is used to indicate the presence or absence of fever, or to monitor body temperature changes.||B|
|2||Bed exit monitor,Fall prevention||Intended to be placed under mattress and used to indicate by an alarm or other signal when a patient attempts to leave the bed.||A|
|3||Electrically powered spinal fluid pressure monitor||Inteded to measure spinal fluid pressure by the use of a transducer which converts spinal fluid pressure into an electrical signal.||B|
|4||Spinal fluid manometer||A spinal fluid manometer is a device used to measure spinal fluid pressure using nnedle and graduated column.||B|
|5||Stand-on patient scale||Intended for medical purposes that is used to weigh a patient who is able to stand on the scale platform.||A|
|6||Patient scale||A patient scale is a device intended for medical purposes that is used to measure the weight of a patient who cannot stand on a scaleby placing scale under a bed or chair to weigh both the support and the patient.||A|
|7||Sterilization process indicator (Biological)||A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization on medical device.||B|
|8||Sterilization process indicator (Physical/chemical)||A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process on medical device.||B|
|9||Clinical color change thermometer.||A clinical color change thermometer is a disposable device used to measure a patient's oral, rectal, or axillary (armpit) body temperature.||A|
|10||Clinical electronic thermometer.||A clinical electronic thermometer is a device used to measure the body temperature of a patient.||B|
|11||Clinical mercury thermometer.||A clinical mercury thermometer is a device used to measure oral, rectal, or axillary (armpit) body temperature using the thermal expansion of mercury.||B|
|12||Apgar timer.||The Apgar timer is a device intended to alert a health care provider to take the Apgar score of a newborn infant.||A|
|13||Hydraulic adjustable hospital bed.||Intended for medical purposes that consists of a bed with a hydraulic mechanism operated by an attendant to adjust the height and surface contour of the bed.||A|
|14||Manual adjustable hospital bed.||A manual adjustable hospital bed is a device intended for medical purposes that consists of a bed with a manual mechanism operated by an attendant to adjust the height and surface contour of the bed.||A|
|15||Pediatric medical crib.||Intended for medical purposes for use with a pediatric patient.||B|
|16||Medical bassinet.||Intended for medical purposes in hospital for use (birth to approximately 5 months of age) in a nursery, labor and delivery unit, or patient room.||B|
|17||Nonpowered flotation therapy mattress.||A nonpowered flotation therapy mattress is a mattress intended for medical purposes which contains air, fluid, or other materials, to treat or prevent decubitus ulcers (bed sores).||A|
|18||Therapeutic medical binder.||Intended for medical purposes and that can be secured by ties so that it supports the underlying part of the body or holds a dressing in place like abdominal, breast and perineal binder.||A|
|19||Burn sheet.||Inteded to wrap aroung a burn victim to retain body heat, to absorb wound exudate, and to serve as a barrier against contaminants||A|
|20||Neonatal eye pad.||A neonatal eye pad is an opaque device used to cover and protect the eye of an infant during therapeutic procedures, such as phototherapy.||A|
|21||Pressure infusor for an I.V. bag.||Device inteded to inflate and increases the pressure on the I.V. bag to assist the infusion of the fluid||B|
|22||Intravascular administration set, automated air removal system.||Inteded to detect and automatically remove air from an intravascular administration set with minimal to no interruption in the flow of the intravascular fluid.||B|
|23||Patient care reverse isolation chamber.||Device inteded protects a patient who is undergoing treatment for burns or is lacking a normal immunosuppressive defense due to therapy or congenital abnormality.||B|
|24||Patient lift, Electrcially powered||Inteded to lift and transport patients in hsoptial in the horizontal or other required position from one place to another, as from a bed to a bath.||B|
|25||Nipple shield.||A nipple shield is a device consisting of a cover used to protect the nipple of a nursing woman.||A|
|26||Lamb feeding nipple.||A lamb feeding nipple is a device intended for use as a feeding nipple for infants with oral or facial abnormalities||A|
|27||Neonatal phototherapy unit.||A neonatal phototherapy unit is a device used to treat or prevent hyperbilirubinemia (elevated serum bilirubin level).||B|
|28||Suction snakebite kit.||Intended for removing venom from the wound.||A|
|29||Therapeutic scrotal support.||Intended for medical purposes to support the scrotum (the sac that contains the testicles)||A|
|30||Umbilical occlusion device.||An umbilical occlusion device is a clip, tie, tape, or other article used to close the blood vessels in the umbilical cord of a new-born infant.||A|
|31||Cardiopulmonary resuscitation board.||Intended to be placed under a patient to act as a support during cardiopulmonary resuscitation.||A|
|32||Ultrasonic cleaner for medical instruments.||Intended for cleaning medical instruments by the emission of high frequency soundwaves||B|
|33||Sharps needle destruction device.||Intended to destroy needles or sharps used for medical purposes by incineration or mechanical means.||B|
|34||Medical insole.||Intended for medical purposes that is placed inside a shoe to relieve the symptoms of athlete's foot infection by absorbing moisture.||A|
|35||Remote Medication Management System.||The system is intended to store the patient's prescribed medications in a delivery unit, to permit a health care professional to remotely schedule the patient's prescribed medications, to notify the patient when the prescribed medications are due to be taken, to release the prescribed medications to a tray of the delivery unit accessible to the patient on the patient's command, and to record a history of the event for the health care professional.||B|
|36||Surgical Light, Single or Multi dome||Intended for medical purposes that is used to illuminate body surfaces and cavities during Surgery.||B|
|37||Medical examination light, AC powered or Battery||Intended for medical purposes that is used to illuminate body surfaces and cavities during a medical examination.||B|
|38||Skin pressure protectors.||A skin pressure protector is a device intended to reduce pressure on the skin over a bony prominence to reduce the likelihood of the patient's developing decubitus ulcers (bedsores)||A|
|39||Medical ultraviolet air purifier.||A medical ultraviolet air purifier is a device intended for medical purposes in hospital/clinic to destroy bacteria in the air by exposure to ultraviolet radiation.||B|
|40||Body waste receptacle.||A body waste receptacle is a device intended for medical purposes that is not attached to the body and that is used to collect the body wastes of a bed patient.||A|
|41||Vacuum-powered body fluid suction apparatus.||A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids.||B|
|42||Washers for body waste receptacles.||A washer for body waste receptacles is a device intended for medical purposes that is used to clean and sanitize a body waste receptacle, such as a bedpan.||B|
|43||Sterilization wrap.||It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used||B|
|44||General purpose disinfectants.||A general purpose disinfectant is a germicide intended to process noncritical medical devices and equipment surfaces.||B|
|45||Hand-carried stretcher.||A hand-carried stretcher is a device intended to carry patient as an assistance for injury or disability.||A|
|46||Liquid crystal vein locator.||Inteded to indicate the location of a vein by revealing variations in the surface temperature of the skin.||A|
|47||Medical washer.||Intended for general medical purposes to clean and dry medical devices, which later undergo sterilization or disinfection before use on patient.||B|
|48||Blood grouping slides||Blood grouping slides are glass surfaces intended to perform the test for finding the blood group.||A|
|49||Blood bank pipettes||Blood bank pipettes are disposable blood handling equipment intended to transfer blood fron one surface to other.||A|
|50||Blood mixing and blood weighing devices||A blood mixing device is a device intended for medical purposes that is used to mix blood or blood components by agitation. Also intended to weigh blood or blood components as they are collected.||A|
|51||Blood Vacutainer||Intended for the drawing of a predetermined volume of blood using vaccum to a container containing Ethylenediaminetetraacetic acid.||B|
|52||Blood bank centrifuge||Intended to separate blood components of a suspension by application of centrifugal force.||A|
Central Drugs Standard Control Organisation:
India is growing as one of the nation's leading in the pharmaceutical businesses and is among the top ten nations in terms of the pharmaceutical industry. Several factors such as a 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’s & 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 ventilator, 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 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 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.
Step3: Fill out the applicable 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 cancelled 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.
This portion of the site is for informational purposes only. The content is not legal advice. The statements and opinions are the expression of author, not corpseed, and have not been evaluated by corpseed for accuracy, completeness, or changes in the law.
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