Overview of CDSCO
On 18 April 2021, CDSCO (central drug standard and control organization), the regulatory body of India, released a list of devices that need to be regulated. CDSCO is India’s regulatory body and operates under the Ministry of Health & Family Welfare, which regulates drugs & medical devices. CDSCO sets the rules and regulations so manufacturers and importers can sell and distribute their devices without legal consequences. To help the manufacturer, CDSCO released a notice with Order No. S.O. 775(E), dated February 8, 2019. It states that all implantable medical devices like MRI machines fall under the non-notified medical devices
In this article, NKG will give a step-by-step guide on how to register MRI machines:
What is an MRI machine
MRI (Magnetic resonance imaging) is a non-invasive method that produces detailed three-dimensional structural images. It works on cutting-edge technology that excites and detects the changes in the rotational axis of hydrogen nuclei (protons) in the water, which makes up biological tissues. It is used worldwide to detect, diagnose, and track the progress of the disease. In MRI machines, powerful magnets are used that produce a strong magnetic field that forces the body’s protons to align with it. To get the image, the patients are placed inside a large magnet and must stay still during the imaging process so that the image doesn’t get blurred. Contrast agents are given to a patient intravenously before or during the MRI to increase the alignment speed of the protons with the magnetic field. The fast the proton realigns, the bright image will appear.
Type of MRI machines
There are two types of MRI machines:
- Closed bore – Closed MRIs are closed and tight heads. It is also called a traditional MRI machine.
- Open bore – The machine is open; one magnet is placed above and the other under the patient. It is mainly designed for those who are claustrophobic, but images are not as clear as the closed bore.
Class of MRI machine
MRI machine belongs to Class C high risk as it involves a high magnetic field, contrasting gels, and strong magnets, which, if used above the limit, can cause harm to the patients.
Forms required for MRI machine registration
Applicant type | Class | Application | License | Fees |
Manufacturer |
Class C | Form MD-7 | Form MD-9 | For one site, INR 50000, and INR 1000 for a medical device |
Manufacturer (Loan License) | Form MD -8 | Form MD -10 | ||
Importer | Class C | Form MD- 14 | Form MD- 15 | $3000 for one site and $1500 for one medical device unit |
Documents required for MRI machine registration
For manufacturers of CT scans:
- Cover letter
- Fees
- Constitution details of the manufacturing firm.
- The Establishment /Site Ownership/Tenancy Agreements.
- Duly notarized quality certificate for manufacturing site(s), if any;
- Copy of the Certificate supporting the quality management system (ISO: 13485), if any;
- Quality management system as per the medical device rule,2017.
- Reference for predicate device,
- Plant master file
- Device master file
- Test license (for the domestic manufacturer)
- Undertaking that the manufacturing site complies with the quality management system.
For the import license authorized agent needs to submit the following documents:
- Cover letter
- Power of attorney
- Wholesale license
- Free sale certificate from the country of origin.
- Free sale certificate from any country, namely USA, Australia, Canada, Japan, UK, and European Union countries.
- Inspection or audit report
- Certificates (ISO, full quality certificate, CE design certificate, Declaration of conformity)
- Plant master file (as per appendix I of MDR, 2017)
- Device master file (as per appendix II of MDR, 2017)
- Label and IFU
- Establishment certificate
- Constitution details of the authorized Indian agent.
Steps to register MRI machine in India
Step 1: Applicant needs to determine if the device falls under the category of notified MRI MACHINE medical devices, which needs registration in India as per the notification of CDSCO.
Step 2: Applicant needs to classify the MRI MACHINE devices in a risk-based class (Class C,) based on the risk they have.
Step 3: Applicant must fill out the application to get permission to manufacture based on the class Form M-7 (Class C & D) or Form MD- 8 (Loan license Class C) or Form MD-14 to import the MRI MACHINE medical device to market it in India.
Step 4: The importer needs to appoint the Indian authorized agent, per the MDR,2017 rules, as the manufacturer’s legal representative who will look out for all the manufacturer’s official work if the manufacturer is not a residMRI machine of India.
STEP 5: Applicant needs to submit the following documents for the MRI MACHINE medical device:
STEP 6: Notified body audits the manufacturing site within 60 days of application submission for Class C. Notified body sends the audit report to the Central licensing authority (CLA) within 30 days to permit the manuafcturing license whereas for import license no audit takes place. For import license audit report is needed, also if the need may be CLA can do the audit and the expense will be paid by the importer
STEP 7: Central licensing authority (CLA) permits the license to manufacture MRI MACHINE medical devices through Form MD-9 (Class C) and Form MD-15 to import and Form MD -10 (Class C & D loan license to manufacturer).
STEP 8: Market MRI MACHINE medical devices in India when it gets the green signal from the CDSCO
TAT (Time for getting File approved)
3-4 Months After application submission.
Conclusion: The MRI machine market is stood at 251.59 million dollars and is expected to grow at 6% during the forecast year (2022-2027). The government making and promoting new policies to improve the medical device market in the coming years are critical for manufacturers and importers. There will be high competition, but the person with the proper license will win the race. And to get the license, one needs complete information on documentation, how to apply for the license, and things to keep in mind. After the CDSCO notification, manufacturers and importers must register their MRI machine machines before entering the Indian market. CDSCO is amending the laws to ensure that MRI machines in the market are safe, effective, and have a high benefit-risk ratio. Since they belong to moderate class risk, the manufacturer and importer need to pay special attention to their documents if they don’t want to interrupt the supply of their MRI machine machines. Thus, it is advisable to consult an experienced regulatory person who can help to get the license without any delays.
Download Checklist of Documents Required for Registration of Medical Devices with CDSCO
These comprehensive set of checklists are designed to help streamline the registration process and ensure that you have all the necessary documentation in place.
