What is oncology and oncology medical device?
Cancer is one of the deadliest and most spread diseases in India and worldwide. India is in 3rd position in terms of cancer patients; as per the National Cancer Registry Program report, approximately 13 lakh people have cancer every year. According to the Indian Council of Medical research, it is estimated to have a 12% increase in cancer patients yearly for the next five years. The most common cancer seen among patients is breast, cervical and oral cancer. Oncology is the term used to define the branch of science that deals with the study of cancer and tumors. Onco means “bulk or mass or tumor”, whereas logy means “study”, thus oncology is the branch that helps diagnose cancer and then decide the route of treatments. Medical devices can be any device, apparatus, instrument, machine, appliance, implant, or reagent used on humans or animals intended by the manufacturer to analyse, treat, prevent or diagnose the disease, condition, etc. Thus, oncology medical devices can be defined as those used in diagnosing, treating, and mapping the severity of cancer and tumor. For example – MRIs, PERT scans, and ultrasounds are the devices that the oncologist mostly and regularly uses to check the growth and reach of cancerous cells and tumors in the body.
With the increased cases of cancer in India, it became very important for the Central Drug and Control Standard (CDSCO) regulatory body of India to separately regulate oncology medical devices. Thus, Drug Controller General India (DCGI) has notified the classification of 48 oncology medical devices under the Medical Devices Rule, 2017. As CDSCO registration consultant we assist oncology medical devices makers to obtain the CDSCO manufacturing license.
Unlike other medical devices the oncology, medical devices too are classified based on the risks they have when used.
Risk-based class | Risks associated | Example |
Class A | Low risk | Reusable cervical cytology scraper |
Class B | Low to moderate risk | Colonic cytology scraper |
Class C | Moderate to high risk | Cryosurgical test |
Class D | High risk | Alternation electric field antimitotic cancer treatment system |
Not only risks but many other factors affect the classification of oncology medical devices, such as:
- Contact duration with the body
- Invasiveness degree
- What medical device delivers energy or medicinal product to the patient’s body
- The biological effect of the medical device on patient
Any medical device not embedded into the medical device, which means the software is a medical device on its own, is called standalone software and falls under the category of software as a medical device. It is also classified based on the following:
- If the software has any effect or drives the other medical devices, then classification depends on the intended purpose of the combination.
- If it is independent software, then it is classified as per classification rules.
- Standalone software is considered an active medical device.
In the case of the medical device that is used in combination with other devices, if they comply individually with the regulations, then in combination, their classification depends on the intended use, packaging, and marketing.
If any accessories are specified for a particular oncology medical device functioning, it will undergo the same regulatory practice as the main device.
STEPS TO REGISTER ONCOLOGY MEDICAL DEVICES IN INDIA:
STEP 1: Identify if the oncology medical device needs a registration – CDSCO has given a list of 48 oncology medical devices in its portal. The device under this list needs registration under the Drug and Cosmetic Act 1940 and MDR 2017. If the medical device is new, then a NOC is required.
STEP 2: Classify the oncology medical device – Classify the oncology medical device based on the risks, invasiveness, degree of contact, etc.
STEP 3: Appoint the Indian authorised agent – in the case of a foreign manufacturer, they need to appoint a valid Indian authorised agent who can look out for the manufacturing operations in India.
STEP 4: Fill out the form – There are MD forms present in the CDSCO online portal, which one needs to fill to manufacture, as per their requirement.
STEP 5: Submit the document – If anyone wants to manufacture the oncology medical device, then they need to submit the documents as per the requirements
MD form | Description |
Form MD – 3 | Application of license to manufacture class A and B medical devices. |
Form MD- 5 | License to manufacture medical devices Class A and B |
Form MD – 7 | Application of license to manufacture class C and D medical devices. |
Form MD- 9 | License to manufacture medical devices Class C and D. |
STEP 6: Issuing of license – If the documents are correct, then the CDSCO will issue the license as per the requirement filled by the applicant, which is either for manufacturing.
DOCUMENTS REQUIRED FOR ONCOLOGY MEDICAL DEVICE REGISTRATION:
Unlike other medical devices, oncology medical devices have the document requirement divided into pre-screening, online portal registration, and manufacturing.
- Cover letter
- ID proof
- The regulatory status of the medical device in the country of origin
- Corporate address
- Copy of manufacturing and wholesale license
- Name and address of the entity of the manufacturing unit
- Details of the medical devices
- ISO 13485 certificate
- Duly signed undertaking stating that information provided by the manufacturer is authentic.
- Self-attested copy of authorization letter to the person issued by the Director/Company Secretary/Partner of the Indian Agent firm
- Detail Product description along with the material of construction, intended use, Product specification, product literature, package inserts along with a sample
Oncology medical devices have been in demand for the past few years due to the increase in cancer cases. Oncology medical devices need to be regulated like any other medical device, as they, too, affect the route of treatment a patient will receive. Thus, manufacturers must comply with oncology medical device regulations if they want to continue selling their devices in the Indian market, as non-compliance can lead to license cancellation and penalties. As a medical device regulatory consultant, we provide end to end assistance oncology medical device manufacturers. Feel free to contact us for any assistance or licensure.
