Nebulizer – U&T Standardisation Marks

CDSCO Medical Device Registration for Nebulizer

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CDSCO Medical Device Registration for Nebulizer - Process, Documentation, Fee

CDSCO stands for The Central Drugs Standard and Control Organisation. It is India’s National Regulatory Authority (NRA) for Cosmetics, Pharmaceuticals and Medical Devices, being a highly powerful organization of India.

Within the CDSCO, the Drug Controller General of India (DCGI) regulates Pharmaceuticals & Medical Devices and its positioning with the Ministry of Health and Family Welfare. Under Drugs and Cosmetics Act 1940 and Rules 1945, import, manufacturing, sale and distribution of drugs is regulated in India.

Overview

What is a Nebulizer as a Medical Device?
CDSCO Medical Device Registration Process
Steps to be followed for Registration
Benefits of CDSCO Registration
Documents Required for Registration
Conclusion

What is a Nebulizer as a Medical Device?

A Nebulizer is a piece of Medical equipment, used by a person with asthma or another respiratory condition which is used to start medication directly and quickly.

It is a medical device also known as atomizers that converts liquid medicine into mist or aerosol, which has to be inhaled directly to the lungs. A nebulizer is used to treat respiratory conditions.

What is CDSCO Medical Device Registration for Nebulizer?

CDSCO Registration is the process of obtaining approval from the regulatory authority to ensure the efficiency and quality of Pharmaceuticals, Medical Devices and Cosmetics.

Importers and Manufacturers of Nebulizers need to take an Import and Manufacturing license from the concerned authority in order to perform several activities with no hindrances.

Process For CDSCO Medical Device Registration for IVD Lab Kits

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 Form

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 Of CDSCO Registration for Nebulizer

The benefits acquired after CDSCO registration for Nebulizer 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 For CDSCO Medical Devices Registration for Nebulizer

Important documents required in the process are as follows:

Application form (Form 40)
TR6 Challan
ISO 13485 Certificate
Power of attorney
The undertaking of authentic details
CE design certificate
Full quality assurance certificate
Declaration of conformity
Schedule D(I)
Device Master File
Plant Master File
Free Sale Certificate

Conclusion

CDSCO Medical Device Registration for Nebulizer is a mandatory step to be done under Medical Device Rules,2017. The selection of applications varies according to the device type, applicant characteristics, and home country approval. The CDSCO grants licenses for device testing, Import or Manufacturing after carefully evaluating each application.

LEGAL METROLOGY (LMPC)

UN MARK IP

Drug License

Cosmetics

Medical Devices