CDSCO Registration for CT Scan Machine: An Overview

The Ministry of Health & Family Welfare, Government of India, has notified the list of tools or devices that will regulate drugs. This regulation was already effective by April 01, 2021. According to the order, the manufacturers/ importers of medical devices and equipment like CT Scan devices, MRI devices, PET devices, dialysis machines, defibrillators, X-ray machines, bone marrow cell separators, and all implantable medical tools and devices will require manufacturing or import license by the Central Licensing Authority and State Licensing Authority. We will discuss the CDSCO Registration for CT Scan Machine in this Article.

List of equipment &Devices that will require CDSCO Registration

Sr. No.	List of equipment and devices that will require import/manufacturing license
1.	All implantable medical devices
2.	CT scan equipment
3.	MRI equipment
4.	Defibrillators
5.	PET equipment
6.	Dialysis Machine
7.	X-ray Machine
8.	Bone marrow cell separator

Ultrasound Devices under CDSCO Regulation

The New Device third Notification has amended the date of notifications dated October 16, 2016, and has brought ultrasound medical devices under CDSCO regulation from November 01, 2020, extending to November 01, 2021.

We will observe the CDSCO’s progress and shall implement the new regulatory scope for development. India is regarded as one of the top worldwide medical devices markets with its unique offer towards device imports.

The country’s agency for regulation of equipment, CDSCO, has classified medical devices that head through the DCGI (Drug Controller General of India) and has classified medical devices into four classes per regulation (A, B, C, D).

Risk-Based Classifications for Medical Devices under CDSCO

Medical Devices under CDSCO are generally based on the risks and the medical devices intended use and purpose, and an accurate risk-based classification is done. The medical devices under the CDSCO classification have a larger group of devices, such as stents & cannulas, in more subgroups that are specific.

• Low Risk (Class A): Surgical dressing, Absorbent cotton wools, alcohol swabs, etc.
• Low Moderate Risk (Class B): BP monitoring device, Thermometer, disinfectants etc.
• Moderate High-Risk (Class C): Haemodialysis catheter, Implants etc.
• High Risk (Class D): heart valve, Angiographic guide wire.

Who can apply for CDSCO Registration for CT Scan Machine in India?

Following are the applicant who can apply for online CDSCO Registration for CT Scan Machine in India:

1. Indian Agents;
2. Corporates;
3. Importers;
4. Foreign Enterprises are holding Indian Subsidiary.

Note: A manufacturing unit cannot register directly on the website/portal. A corporate needs to create login authorisation for the manufacturing team to log in on the portal.

Documents required for the CDSCO Registration for CT Scan Machine.

• Form 40
• ISO 13485 Certificate^[1]
• Full Quality Assurance Certificate
• CE Design Certificate
• Undertaking that all details provided is authentic
• Either a Free Sale Certificate/ Certificate from the Foreign Government
• Certificate of Marketability from GHTF (Australia, Japan, Canada, the European Union, and the UnitedStates);
• Plant Master Report
• Device Master File

Procedure for Obtaining CDSCO Registration for CT Scan Machine.

The CDSCO Registration is entirely Online. Following are the procedures for obtaining CDSCO Registration through the online CDSCO Portal:

Step 1: First, you have to visit the CDSCO Registration portal.

Step 2: Then you need to apply for registration for that; you have to go to the Registration motive page and click on submit.

Step 3: Once you open the Application Registration page, fill in all the vital information as provided in the application form, such as:

• Applicant Type;
• Name;
• User Names;
• Password;
• Mobile Number;
• Email ID.

Fill out the Registered Indian Address Form that contains information like:

• Organisation Name & Type;
• CIN;
• Contact Number;
• Address;
• Upload the Corporate Address Proof.

Step 4: Once you apply correctly, you will get a confirmation link to your registered email ID to verify the registration. Then you have to click on the link to activate your account on the CDSCO portal.

Step 5: After the confirmation link is clicked, the application for CDSCO Registration for CT Scan Machine will be sent to the concerned Department for Approval.

Step 6: After the CDSCO Registration for CT Scan Machine application is approved, send an approval email to your registered email ID. If the application is rejected, an email for rejection will send to your email ID.

Time taking and Validity for CDSCO Registration for CT Scan Machine

If the DGCI does not ask for a Technical Presentation or subject Expert Committee (SEC) audit, it will take almost 6 to 9 months to get a Medical Devices Registration. If where Technical Presentation or Subject Expert Committee (SEC) audit is required, it may take an additional 3 to 6 months.

After obtaining, the Registration Certificate shall be valid for three years from the date of grant of registration unless suspended/ cancelled through the DGCI Authority for good reasons.

Conclusion

The medical industry is looking at two critical developments in 2021: whether it will make any improvement to propose separate legislation to control medical equipment under CDSCO and whether the required licenses for import of medical equipment will be given promptly by the CDSCO.