A Brief Introduction of Radiotherapy:
Radiation therapy is used to destroy cancer cells using high–energy x-ray or other particles. Radiation oncologist is the specialist who gives radiation therapy to treat cancer. There are a specific number of treatments given over a period of time, these are called radiation therapy regimen. This type of therapy can treat different types of cancer-related diseases. The radiotherapy technique can also be used in other types of cancer treatments like chemotherapy and surgery etc.
Table of Contents
- A Brief Introduction of Radiotherapy:
- 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 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 Radiotherapy category consists of a total of 22 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
|RADIOTHERAPHY MEDICAL DEVICES|
|S. No.||Name of the Product||Intended use||INDIA|
|1||Brachytherapy system chair||A mains electricity (AC-powered) device (a chair or stool) that is a component of a brachytherapy system and which is specifically designed to support and position a patient during brachytherapy radiation treatments given by either a manual applicator or a remote after loading brachytherapy system applicator.||B|
|2||Compact thermoluminescent dosimetry electrometer||Thermoluminescence dosimeter (TLD) is used to measure the radiation dose emitted to the phantom, eyes and other organs with high radio sensitivity.||B|
|3||Intra-vaginal organ positioning device for diagnostic imaging and radiotherapy||A device that is specifically designed to be inserted in the vagina to properly position and fix the surrounding organs such as uterine cervix, rectum, and urinary bladder for image diagnosis or radiotherapy. This device is used to facilitate reproducible positioning for continuous image examination or continuous radiotherapy.||B|
|4||Laser irradiation therapy kit||A kit includes a puncture needle, a guide wire, and a guiding sheath for guiding probes (used for laser irradiation therapy, for example). Not all of the components are included; in some products, two or more of components are integrated into one.||B|
|5||Light beam patient position indicator||A light beam patient position indicator is a device that projects a beam of light (incoherent light or laser) to determine the alignment of the patient with a radiation beam.||B|
|6||Manual radionuclide applicator system||A manual radionuclide applicator system is a manually operated device intended to apply a radionuclide source into the body or to the surface of the body for radiation therapy.||B|
|7||Non-powered accelerator system table||A mechanically-operated bed for radiotherapy designed to adjust the patient's posture and immobilize the patient for radiotherapy that uses a medical linear accelerator or non- linear accelerator.||B|
|8||Non-powered neutron therapy table||A bed for radiotherapy designed to adjust the patient's posture and immobilize the patient for treatment that uses neutron rays that are generated from a nuclear reactor, etc. It is equipped with a table top that fixes the posture, pneumatic control, magnetic lock, crank, and lever for mechanical table top positioning control and table height control.||B|
|9||Radionuclide brachytherapy table||A programmable bed for electric radiotherapy to adjust the patient's posture and immobilize the patient for treatment that uses an after loading short-distance irradiation treatment apparatus that is operated manually or electrically.||B|
|10||Non-powered remote irradiation therapy table||A bed for radiotherapy designed to adjust the patient's posture and immobilize the patient for treatment that uses a remote radionuclide radiotherapy apparatus.||B|
|11||Non-powered X-rays radiation therapy table||A bed for radiotherapy designed to adjust the patient's posture and immobilize the patient for treatment that uses an X-ray therapy apparatus.||B|
|12||Operator radiation protection spectacles||A personal protection device that protects the eyes of the operator and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with diagnosis and treatment.||B|
|13||Patient positioning device for pelvis diagnostic imaging and radiotherapy||The device that consists of frames, plates, or other parts, and is specifically designed to properly position and fix the patient's abdomen and pelvic region for image diagnosis, image-guided surgery, interventional therapy, or radiotherapy.||B|
|14||Patient positioning device for whole body diagnostic imaging and radiotherapy||A device that consists of fixed or adjustable parts (e.g., frames and plates), and is specifically designed to properly position and fix the patient's whole body for image diagnosis, image-guided surgery, interventional therapy, or radiotherapy.||B|
|15||Powered neutron therapy table||A programmable bed for radiotherapy designed to adjust the patient's posture and immobilize the patient for treatment that uses neutron rays that are generated from the nuclear reactor, etc.||B|
|16||Powered patient table for accelerator||A bed operate by programmable for electric radiotherapy designed to adjust the patient's posture and immobilize the patient for radiotherapy that uses medical linear accelerator or non-linear accelerator.||B|
|17||Powered radionuclide brachytherapy table||A programmable bed for radiotherapy designed to adjust the patient's posture and immobilize the patient for treatment that uses an after loading short-distance irradiation treatment apparatus that is operated manually or electrically.||B|
|18||Powered remote irradiation therapy table||A programmable electrically operated bed for radiotherapy designed to adjust the patient's posture and immobilize the patient for treatment that uses a remote cobalt 60 radiotherapy apparatus and other remote radionuclide radiotherapy apparatuses.||B|
|19||Powered X-rays radiation therapy table||A programmable electrically operated bed for radiotherapy designed to adjust the patient's posture and immobilize the patient for treatment that uses an X-ray therapy apparatus.||B|
|20||Radiographic Protective Glove||A personnel protective glove is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation||B|
|21||Radionuclide dynamic function testing equipment||A device used to measure and record temporal variations of radioisotope concentrations in the body. Specialized devices, such as devices for thyroid uptake measurement, renograms, and radioisotope blood volume measurement, are included.||B|
|22||Stationary radiation protection barrier||A device for permanent installation that forms a structural barrier that shields or attenuates radiation emitted from primary radiation source or scattered radiation source.||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 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 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 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
For one site
For each device
|A or B;||20(2)||Rs. 5000
|For Manufacturing/Loan License
For one site
For each device
|C or D;||21(2)||Rs. 50,000
|For Import License(other than IVD)
For one site
For each device
|Class A||34(2)||1000 Dollar
|Import License(other than IVD)
For one site
For each device
|Class B||34(2)||2000 Dollar
|Import License (in IVD)
For one site
For each device
|Class A or B||34(2)||Rs. 1000
|Import License (other than IVD)
For one site
For each device
|Class C or D||34(2)||3000 Dollar
|Import License(in IVD)
For one site
For each device
|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.
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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