CDSCO Registration for MRI Scan Machine
A form of scan called an MRI, or magnetic resonance imaging, creates precise images of the body inside the scanner by combining radio waves and powerful magnetic fields. It is used to identify diseases, provide a diagnosis, and monitor their progression. The list of equipment and devices that will be treated as pharmaceuticals was announced by the Ministry of Health & Family, Government of India, for regulation in 2021. According to the order, manufacturers or importers of equipment and medical devices, such as MRI machines, CT scan machines, x-ray machines, dialysis machines, etc., as well as all implantable medical devices, will need to obtain a manufacturing or import license from the State Licensing Authority or Central Licensing Authority, respectively. We shall talk about CDSCO Registration for an MRI scanner in this article consisting of Process, documents needed and how Regalguru can help in acquiring the said registration.
CDSCO Registration of Medical Devices
India is one of the countries with the fastest-growing pharmaceutical industries, thanks to a number of variables including its sizable population, reasonably priced healthcare options, rising public health consciousness, and improved research infrastructure. However, there is a chance that medical devices and equipment would be sold or bought illegally due to the expansion of the pharmaceutical business in India.
Because of this, the Indian government established CDSCO (Central Drug Standards Control Organization), which serves as the country's principal legislative body and is in charge of managing and regulating the country's pharmaceutical and medical device industries.
Documents Needed to Register an MRI Scanner with CDSCO
The following are some important documents needed to register an MRI scanner with CDSCO:
- Application form completed in full,
- A CE Design Certificate,
- A plant master report, and
- A device master file; pledging that all the information provided by the application is true and accurate
- Full certificate of quality assurance
- Obtain a Free Sale Certificate (FSC) or a certificate from a foreign government;
- Information about the actual place;
- The manufacturer's name, address, and contact information.
The Process for Registering an MRI Scanner with CDSCO
The steps for CDSCO registration for an MRI scanner are as follows:
Step 1: Determine whether the necessary medical device is in the notified list of medical devices: A list of notified medical devices that must be registered under the 1940 Drugs & Cosmetics Act and the 2017 MDR has been supplied by the CDSCO. Any medical devices that haven't been notified by the CDSCO or any new medical devices in India require a NOC from the maker or importer in these circumstances.
Step 2: Select an IAA (for Foreign Entity or Manufacturer): It is required that foreign manufacturers appoint an IAA (Indian Authorized Agent) in India. This person will act as the manufacturer's point of contact for inspection authorities during the CDSCO Registration for MRI Scan Machine process and will assist with registration, device approvals, and vigilance adverse event reporting. The Indian Authorization has to be licensed to sell wholesale drugs.
Step 3: Filling out the Application Form: The MRI Scan Machine's manufacturer or importer must submit the Registration Form on the CDSCO website together with the necessary paperwork & the needed money in this step.
Step 4: Registration Certificate Issuance: The authority may send a question via an inquiry letter representative after the applicant submits the application form, supporting documents, and payment of costs. The authority may grant a license once it is satisfied. The manufacturer or his/her authorized agent may submit an application for an importer license after receiving CDSCO Registration for an MRI Scanner.
Note: The CDSCO Registration for an MRI Scan Machine is good for three years from the day the Registration Certificate was issued, unless the DGCI authority suspends or cancels it.
CDSCO Registration for an MRI Scanner Must Be Renewed
At least nine months before the CDSCO Registration for MRI Scan Machine's expiration date, the renewal application must be submitted. Although no additional paperwork is needed for the renewal of Registration, the Certificate Owner shall be required to submit a copy of the PMF (Plant Master File) & Device Master File or DMF.
Conclusion
The Indian MRI equipment market has 290 units and a volume of Rs. 1778.5 crore in 2019; it is anticipated to expand further in the coming years. The market for medical devices in India is anticipated to rise as a result of more new product launches and technical developments. A medical device registration is required because an MRI scanner falls into the Class II (moderate risk) category of medical equipment.
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