CDSCO Registration for MRI Scan Machine – An Overview

CDSCO Registration for MRI Scan Machine
Karan Singh
| Updated: Oct 15, 2022 | Category: CDSCO

MRI or Magnetic Resonance Imaging; it’s a type of scan that uses strong magnetic fields & radio waves to produce detailed images of the body inside the machine. It is used to detect diseases, diagnose them & track their progress. In 2021, the Ministry of Health & Family, Government of India, has notified the list of equipment/devices which will be regulated as drugs. As per the order, the manufacturers or importers of equipment & medical devices like MRI equipment, CT Scan Machines, x-ray machines, dialysis, etc., and all implantable medical devices, will require a manufacturing or import License from State Licensing Authority or Central Licensing Authority, respectively. In this write-up, we will discuss CDSCO Registration for MRI Scan Machine.

An Overview of CDSCO

India is one of the growing nations in the pharmaceutical business, and there are several factors like a huge population, affordable medical facilities, and growing health awareness& better research facilities that have given rise to the development & manufacturing of the pharma business in India. However, with the growth of the pharmaceutical industry in India, there are possibilities for the sale or purchase of medical devices & equipment without jurisdiction or illegally.

That’s why the Indian Government has set up CDSCO (Central Drug Standards Control Organisation)[1], which is the primary legislative body & has been responsible for the control, management, and regulation of pharmaceuticals & medical devices in India apart from the appointment of DCGI and has conferred the responsibility of undertaking assessment, approval & regulation of further compliances (sale, import, export, distribution) in the matters of medicinal drugs & medical devices (including any new or existing devices/drugs) as per the provisions of the Drugs & Cosmetics Act, 1940.

Different Classes of Medical Devices in India

Provisions under the Act related to the manufacture, sale, import & distribution of medical devices are regulated under the Drugs & Cosmetics Act. Under the MDR, 2017, all medical devices in India have been categorised into 4 different categories depending on their usability & risk involved, as mentioned below:

Different Class Risk
Class A Low-Risk (Devices such as tongue depressors, thermometers, etc.)
Class B Low-Moderate Risk (Such as Suction device, Hypodermic Needles, etc.)
Class C Moderate-High Risk (Such as Lung Ventilator, etc.)
Class D High-Risk (Such as implantable devices, etc.)

Note: Class A & Class B medical devices are considered to be less risky & moderate devices, for which the application manufacture devices in India must be filed to the SLA (State Licensing Authority). On the other side, Class C and Class D are high & very high-risk devices, and the application for the same has to be filed to the CLA (Central Licensing Authority).

Documents Required for CDSCO Registration for MRI Scan Machine

Following are some vital documents required for CDSCO Registration for MRI Scan Machine:

  1. Duly-filled application form;
  2. CE Design Certificate;
  3. Plant Master Report;
  4. Device Master File;
  5. Undertaking that all the details provided by the applicant is genuine & authentic;
  6. Full Quality Assurance Certificate;
  7. Get an FSC (Free Sale Certificate) or Certificate from the Foreign Government;
  8. Details of the actual site;
  9. Name, address & contact details of the manufacturer.

Procedure for CDSCO Registration for MRI Scan Machine

Following is the procedure for CDSCO Registration for MRI Scan Machine:

Step 1: Know Whether the Medical Device required is under notified list or not: The CDSCO has provided a list of notified-medical devices that need to obtain Registration under the Drugs & Cosmetics Act, 1940, and as per the MDR, 2017. There may be any medical devices that haven’t been notified by the CDSCO, or in the case of new medical devices in India, the manufacturer or importer must obtain a NOC in this case.

Step 2: Appoint an IAA (for Foreign Entity or Manufacturer): For Foreign manufacturers, it is compulsory to appoint an IAA (Indian Authorised Agent) in India, who shall be the contact person for the inspection authorities at the time of CDSCO Registration for MRI Scan Machine, help the manufacturer in the registration process, device approvals, and vigilance adverse event reporting. The Indian Authorisation must have a Wholesale Drug License.

Step 3: Filling of Application form: In this step, the manufacturer or importer of the MRI Scan Machine shall be required to submit the Registration Form along with the relevant documents & prescribed fees on the CDSCO portal.

Step 4: Issuance of Registration Certificate: Once the applicant submits the application form & documents and pays the fees, then the authority may send a query via an inquiry letter to the manufacturer or from the authorised representative of the importer along with the timeline within which the query should be answered. Once the authority is satisfied, the authority may issue a License. After obtaining CDSCO Registration for MRI Scan Machine, the manufacturer or his/her authorised representative may apply for an importer license.

Note: CDSCO Registration for MRI Scan Machine is valid for 3 years from the date of issue of Registration Certificate unless cancelled or suspended by the DGCI authority.

Renewal of CDSCO Registration for MRI Scan Machine

The renewal application for CDSCO Registration for MRI Scan Machine shall be filed at least 9 months before the expiry of CDSCO Registration for MRI Scan Machine. Though there are no extra documents required for the renewal of Registration, it shall be necessary for the Certificate owner to provide a copy of the PMF (Plant Master File) & Device Master File or DMF where there are no changes in the Device Master File and Plant Master File.

Post Compliance after Getting Registration Certificate

Following are some post-compliance after obtaining a Registration Certificate:

  1. In case of any change that has been taken place regarding the address of the registered factory premises or office or constitution of the firm, the Medical Device manufacturer or authorised representative of the importer to intimate the Licensing Authority about the same in writing.
  2. In case of any change in the existing Registration, the Certificate shall be valid for 3 months from the date on which the change has taken place and at this time, the authorised representative or manufacturer of Medical Devices shall be required to get a new Registration Certificate.

Conclusion

In 2019, the Indian MRI equipment market was Rs. 1778.5 crores and 290 units (by volume) and is expected to grow more in the upcoming period. More new product launches and technological advancements are expected to create market growth for medical devices in India. Since MRI Scan Machine falls under the Class –C medical device category, there is a mandatory requirement for Medical Device Registration.

Read our Article:What is the Meaning of Form MD-8 and Form MD-10?

Spread the love
Karan Singh

A legal writing enthusiast, a wanderer, and a zealous reader. After gaining a lot of knowledge about the diverse legal topics and developing research skills, Karan joined the league of legal content writers to deliver quality-rich blogs.

docsbizkit
 

Related Articles

MEDICAL DEVICE RULES 2017
| Date: Mar 09, 2023 | Category: CDSCO

Medical Device Rules 2017- A Comprehensive Study

Medical devices play a crucial role in modern healthcare. They help diagnose, treat, and monitor diseases and medical conditions. Medical device regulations ensure that all medical devices are safe and...

Read More
Notified & Non-Notified Medical Devices
| Date: Sep 02, 2022 | Category: CDSCO

Difference between Notified & Non-Notified Medical Devices

CDSCO stands for Central Drugs Standard Control organisation. This entity is responsible for the regulation of drugs in India. CDSCO works under the ambit of the Directorate General of health...

Read More
Form MD-7 and Form MD-9
| Date: Nov 02, 2022 | Category: CDSCO

What is the Meaning of FORM MD-7 and FORM MD-9?

A person or a company involved in the manufacturing of Medical Devices in India can distribute/communicate the products by applying through the concerned Authority. The application process includes applying for...

Read More

ARTICLES

Hi! My name is Akanksha! Let's talk.