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CDSCO Registration for General Hospital Medical Devices

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CDSCO Registration for General Hospital Medical Devices - Procedure, Documents required

CDSCO is the Central Drugs Standard Control Organisation, which is the Indian National Regulatory Body for Cosmetics,Pharmaceuticals and Medical Devices.It comes under the Directorate General of Health services, Ministry of Health and Family Welfare and Government of India.

In India, import,manufacturing,sale and distribution of drug and medical devices and cosmetics are regulated under Drugs and Cosmetics Act 1940 and rules 1945. CDSCO with state regulators are responsible for granting the license of specialized medical devices.

Overview

What are General Hospital Medical Devices?

General Hospital Devices and Supplies are those medical devices that health professionals use to support patients or for their own health and safety that are covered in the same category.

There are more than 50 General Hospital Medical Devices, some of them are; Hydraulic Adjustable Hospital Bed, Therapeutic Medical Blinder, Neonatal Eye Pad, Jet lavage etc.

What is CDSCO Registration for General Hospital Medical Devices?

CDSCO registration is a process of obtaining approval from the regulatory authority to ensure the efficiency and quality of cardiovascular medical devices.

The selection of applications varies according to the device type,applicant characteristics,operations and home country approval. The CDSCO grants license for device testing,import or manufacturing after carefully evaluating each application.

Procedure of doing CDSCO Registration of General Hospital Medical Devices.

Step 1 – SUGAM Portal

You need to visit the ‘SUGAM’ registration portal on the official website of CDSCO. Click on the ‘sign up here’ option to start the registration process.

Step 2 – Filling up the details

Fill up the space with required details. Fill the ‘Registered Indian Address Form’ by providing the necessary details.

Step 3 – Documentation

Complete the application process by submitting the required documents for the verification process which is done by the officials of CDSCO.

Step 4 – Confirmation of registration

A confirmation link will be sent to the registered email Id to verify the registration. Click on the link to activate the account on CDSCO-portal.

 

Step 5 -Approval from the officials

 Once the confirmation link is clicked, the application for registration will be sent to the concerned authority for an approval after the verification of the formal documents.

 

Benefits acquired after CDSCO Registration for General Hospital Medical Devices.

The benefits acquired after CDSCO registration for General Hospital Medical Devices can be seen as follows:

  • Indian Market access: India has the largest Pharmaceuticals and medical device market in the world. CDSCO registration allows the manufacturers and importers to sell their products to the consumers in the Indian Market.
  • Ensuring Safety: The main aim of the Central Drugs Standard Control Organisation is to safeguard public health. The quality and efficiency of the device or product goes under a verification process done by the CDSCO officials. The safety and health issues of certain types of equipment are not a concern with registered Medical Devices as a finished product.
  • Brand Recognition: CDSCO registration enhances the manufacturer’s brand recognition and credibility, as it demonstrates that the products have met rigorous safety, efficacy, and quality standards.

Documents required for CDSCO Registration of General Hospital Medical Devices.

Important documents required in the process are as follows:

  • Application Form MD 40
  • Power of Attorney
  • Certificate of quality assurance
  • Challan TR6
  • Plant-Master File
  • ISO 13485 certificate
  • An Undertaking declaring that the information stated is correct
  • Device-master file
  • Free sale certificate

Conclusion

Central Drugs Standard Control Organisation which is the National Regulatory Authority of India (NRA) issues licenses for specialized medical devices after checking the quality and efficiency of the device or product. Holding a CDSCO license enhances brand reputation and brings several benefits to the holder.