A brief introduction of Pain Management
The study of pain prevention, diagnosis, and treatment is commonly known as pain management, a branch of medicine that also incorporates complementary and alternative healing modalities. Pain management is used as an active conservative (nonsurgical) therapy approach for painful spine and musculoskeletal issues to help find the cause of neck and back pain and rehabilitate the patient as an alternative or follow-up to surgery. Anesthesiologists who have received certification or training in the alleviation and/or management of pain are often the doctors who practise pain medicine or pain management. A physiatrist might also be an expert in pain management. Back pain can be treated with pain management strategies that include massage treatment, analgesic drugs, physical therapy, and epidural steroid injections among others.
Table of Contents
- A brief introduction of Pain Management
- 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 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 Pain Management category consist of total 69 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
|CATEGORY: PAIN MANAGEMENT|
|S. No.||MEDICAL DEVICE NAME||INTENDED USE||INDIA|
|1||Acupressure calf band||A device designed to be worn around the calf to apply pressure to an acupressure point to relieve low back pain, including sciatica and piriformis syndrome.||A|
|2||Acupressure wristband||A device designed to be worn on the wrist(s) for the application of pressure to the Nei-kuan (P6) acupressure point, the area identified to help relieve the sensation of nausea.||A|
|3||Acupuncture Electrical Stimulation system||An assembly of devices used to apply electrical stimuli to acupuncture sites.||B|
|4||Acupuncture kit||A collection of instruments and supplies used to perform acupuncture procedures.||B|
|5||Acupuncture point detector||An electronic probe used to precisely locate an acupuncture point on a patient's body.||B|
|6||Analgesic PENS system||An assembly of devices intended for the relief of chronic neuropathic pain through percutaneous electrical nerve stimulation (PENS).||B|
|7||Analgesic TENS system||An assembly of devices used to reduce the perception of pain by electrically stimulating peripheral nerves across the skin (transcutaneously).||B|
|8||Arthritis TENS system||An assembly of devices intended to be used as adjunctive therapy in reducing the level of pain and stiffness associated with rheumatoid arthritis or osteoarthritis by electrically stimulating peripheral nerves across the skin (transcutaneously).||B|
|9||Arthritis transcutaneous electrical joint stimulation system||An assembly of devices intended to be used as adjunctive therapy in reducing the level of pain and stiffness associated with rheumatoid arthritis or osteoarthritis by electrically stimulating an arthritic joint across the skin (transcutaneously) and to provide an overall improvement to an arthritic joint and defer or avoid surgery.||B|
|10||Bed/chair electric massager||A device intended to provide therapeutic massage to the occupant of a bed or chair for the treatment of body aches and pains.||B|
|11||Bite relief pad||A thin, plastic, horshoe-like wafer that is placed between the upper and lower sets of teeth and bitten down on, or chewed, to help relieve pain or discomfort after orthodontic treatment.||A|
|12||Blue/red/infrared phototherapy lamp||A portable device designed to emit blue light, red light, and infrared radiation (heating effect) for phototherapy treatment of mild skin disorders (e.g., mild acne), superficial skin wounds, and musculoskeletal symptoms (e.g., pain, spasm, stiffness).||B|
|13||Circulating-fluid thermal therapy system||An assembly of devices intended to be used to pump heated and/or cooled fluid through externally applied packs for localized hot and/or cold therapy to help treat a variety of adverse conditions resulting from musculoskeletal injury (e.g., pain, swelling, inflammation).||B|
|14||Cold-air therapy unit||A unit intended to generate and deliver a stream of cold air directly to the skin surface to treat musculoskeletal/rheumatic disorders, to reduce localized pain/inflammation, and/or to reduce thermal skin damage during dermatological laser treatments.||B|
|15||Deep-tissue electromagnetic stimulation system||An assembly of devices designed to apply an electromagnetic (EM) field to body tissues to: 1) treat musculoskeletal disorders; 2) treat body pain; and/or 3) help facilitate soft and hard tissue wound/injury healing, with no production of a therapeutic deep heat.||B|
|16||Ear microsystem needle||An instrument used in auriculotherapy to apply continuous pressure to stimulate meridian points.||A|
|17||Electric pad localized-body heating system||An assembly of devices designed for the transcutaneous application of heat to a localized body site to relieve musculoskeletal pain.||B|
|18||Endothermic cold therapy pack||A device intended to be applied with pressure to the body surface to provide cold therapy to help reduce fever, pain, and inflammation associated with joint/muscle/tissue injury and/or minor burns.||B|
|19||Exothermic heat therapy pack||A device intended to be applied to the body surface, sometimes with pressure, to provide heat therapy to reduce muscle spasms and cramps and/or for joint and muscle stiffness and pain.||B|
|20||Foot bath||A device designed to be filled with water to provide therapeutic heat treatment specifically to the feet. This device is intended to relieve foot pain as well as headaches, coughs, and other cold symptoms.||B|
|21||Heat therapy gel||A non-sterile gelatinous compound in a container that is dispensed for application to the body surface to provide a warming effect for underlying tissues. It is intended to reduce/relieve pain, muscle tension, and to increase local circulation.||B|
|22||Hydrotherapy bath/tank||A bathtub or tank designed to be filled with warm water and occupied by a patient for the application of various forms of physical hydrotherapy such as water jet massage or aquatic exercise, typically to help treat musculoskeletal pain and stiffness or for physical rehabilitation; it is not dedicated to flotation therapy.||B|
|23||Ice bag||Intended to alleviate pain and/or promote healing in minor injuries of the body or for application around the neck or limbs.||A|
|24||Ice collar||Intended to alleviate pain and/or promote healing in minor injuries of the neck, throat, and/or head and to alleviate a sore throat.||A|
|25||Inflatable hot/cold therapy pack/electric pump||A assembly of devices intended for localized thermal and compression therapy to facilitate the treatment of a variety of adverse conditions resulting from musculoskeletal injury.||B|
|26||Inhalational analgesia unit||A device primarily designed to administer analgesic gases to the patient, or produce analgesic vapours for inhalation.||B|
|27||Interferential electrical stimulation system||An device assembly designed to stimulate peripheral nerves through the transcutaneous application of two currents of slightly different frequencies that cross-over/interfere, producing a beating frequency at the treatment point.||B|
|28||Intervertebral disc prolapse therapy pack||A device intended to be applied to the skin overlying an affected area of the spine (cervical or lumbar) to reduce pain associated with a prolapsed (herniated) intervertebral disc.||B|
|29||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|
|30||Inversion table||A fixed framework with a tilting table platform designed to support the body of a patient and provide traction for the back muscles and spine by allowing the patient manually invert their entire body in a supine position (feet up and head down), thereby assist patients eliminate/alleviate back pain.||A|
|31||Massage table/couch||A table designed for various kinds of complementary therapy.||A|
|32||Musculoskeletal infrared phototherapy unit||A device intended to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury and to improve blood circulation in the treated areas to facilitate healing.||B|
|33||Pain-relief phototherapy skin patch||A skin patch designed to reflect the naturally emitted infrared energy back into the body, with a reduced range of wavelength, intended to provide comfort and localized temporary relief of body aches and pains by phototherapeutic stimulation of strategic points on the skin.||A|
|34||Pain-relief static magnet||A magnetized metal device designed to be worn on any part of the body (non-dedicated) and intended to produce a weak magnetic flux field over a superficial body site to provide comfort and localized temporary relief of body aches and pains.||A|
|35||Physical therapy paraffin wax bath||A tub/enclosure, with an internal heating assembly, filled with liquid paraffin wax for physical therapy, to relieve pain and stiffness caused by arthritis or other joint inflammation, muscle spasms, or to help stimulate circulation.||B|
|36||Short-wave diathermy treatment system||An assembly of devices designed to provide a therapeutic deep heat within specific volumes of the body through the transcutaneous transmission of electromagnetic (EM) energy in the radio-frequency (RF) bands. The device is intended to treat pain, muscle spasms, and joint contractures; it is not used for surgery or to treat malignancies.||B|
|37||Sitz bath||A tub filled with water, that is heated by its heating elements and circulated by its agitators, intended for use in external hydrotherapy to relieve pain or pruritus and to accelerate the healing of inflamed or traumatized tissues of the perianal and perineal areas.||A|
|38||Sitz bath chair||A device designed to be sat upon by a patient in a powered sitz bath for external hydrotherapy to relieve pain or pruritus and to accelerate the healing of inflamed or traumatized tissues of the perianal and perineal areas.||A|
|39||Static magnetic back/spine insulator||A pad made of textile fabrics containing magnetic inserts and designed to be placed on the surface of the skin. on the back and/or part or the whole of the spine to help relieve medical ailme andnts such as pain, muscle tension, poor blood circulation and to provide comfort by improving overall mobility.||B|
|40||Static magnetic bed mattress overlay||A pad made of textile fabrics containing magnetic inserts intended to be placed on top of a bed mattress and contact an occupant’s body to help relieve medical ailments such as pain, muscle tension, poor blood circulation and to provide comfort by improving overall mobility.||A|
|41||Static magnetic belt||A device, typically fashioned as a piece of clothing, containing or impregnated with a magnetized metal(s) or metallic compound(s), designed to be worn around the waist to produce a weak magnetic flux field that emanates from the waist to assist the whole body’s innate healing capability to alleviate body aches and pains.||A|
|42||Static magnetic bracelet||A device, typically fashioned as a piece of jewellery, containing or impregnated with a magnetized metal(s) or metallic compound(s), designed to be worn around the wrist to produce a weak magnetic flux field that emanates from the surface of the wrist to assist the whole body’s innate healing capability to alleviate body aches and pains.||A|
|43||Static magnetic elbow orthosis||A body-support device containing or impregnated with magnetized metals or metallic compounds, designed to be worn around the elbow joint to support the elbow and produce a weak magnetic flux field that emanates from the surface of the elbow to assist the whole body’s innate healing capability to alleviate body aches and pains.||B|
|44||Static magnetic foot arch orthosis||A body-support device containing or impregnated with magnetized metals or metallic compounds, designed to be worn in a patient’s shoe, or other footwear, under the arch of the foot to support the arch and produce a weak magnetic flux field that emanates from the surface of the foot arch to assist the whole body’s innate healing capability to alleviate body aches and pains.||B|
|45||Static magnetic joint insulator||A pad made of textile fabrics containing magnetic inserts and designed to be placed on the surface of the skin over/around a patient's hip or other limb joint to help relieve medical ailments such as pain, muscle tension, poor blood circulation and to provide comfort by improving overall mobility.||B|
|46||Static magnetic knee orthosis||A body-support device containing or impregnated with magnetized metals or metallic compounds, designed to be worn around the knee joint to support the knee and produce a weak magnetic flux field that emanates from the surface of the knee to assist the whole body’s innate healing capability to alleviate body aches and pains.||B|
|47||Static magnetic lumbar spine orthosis||A body-support device containing or impregnated with magnetized metals or metallic compounds, designed to be worn around the hips to support the lower back (spine and coccyx) and produce a weak magnetic flux field that emanates from the surface of the lower back to assist the whole body’s innate healing capability to alleviate body aches and pains.||B|
|48||Static magnetic massager||A device designed to be moved over body surfaces that uses static magnets intended to produce a weak magnetic flux over a superficial body site to provide comfort and localized temporary relief from minor aches and pains.||A|
|49||Static magnetic shoulder orthosis||A body-support device containing or impregnated with magnetized metals or metallic compounds, designed to be worn around the shoulder joint to support the shoulder and produce a weak magnetic flux field that emanates from the surface of the shoulder to assist the whole body’s innate healing capability to alleviate body aches and pains.||B|
|50||Static magnetic thoracic spine orthosis||A body-support device containing or impregnated with magnetized metals or metallic compounds, designed to be worn around the waist or across the shoulders to support the back (central- and upper spine) and produce a weak magnetic flux field that emanates from the surface of the central- and upper spine to assist the whole body’s innate healing capability to alleviate body aches and pains.||B|
|51||Traction system belt||A harness designed to provide traction to the lower spine, including the lumbar and pelvic areas, with force from an external traction system. The harness is used mainly for relief of low back pain and to maintain normal alignment of the vertebrae.||A|
|52||Wearable cervical spine traction device||An externally-worn orthopedic device intended to apply traction to the cervical spine/neck to treat pain resulting from non-bone injuries/disorders.||B|
|53||Wearable lumbar spine traction device||An externally-worn orthopedic device designed to apply traction to the lumbar spine to relieve symptoms of back pain and sciatica.||B|
Central Drugs Standard Control Organisation:
India is growing as one of the nation's leading in pharmaceutical business and is among the top ten nations in terms of the pharmaceutical industry. Several factors such as 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.
Step 3: 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|
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 the 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.
To do business in pharma industry including Ayurvedic & Unani drugs, one must get a Drug license to operate legally. As per Drugs Act, 1940, License is mandatory throughout India. A particular license is required based on business requirement.
CDSCO Online Registration
Team Corpseed will help you to get CDSCO online registration / DCGI approval for your products as per CDSCO guidelines. Under the Drugs and Cosmetics Act, CDSCO has many responsibilities which includes approval of Drugs.
Medical Devices Registration
Also, CDSCO regulates the manufacturing and import of medical devices in India. As per Drug and Cosmetic act, the medical devices are categorized under the category of drugs.
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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