How to get a CDSCO License for Nebulizer Manufacturing and Import

How to get manufacturing and import licnese for Nebulisers in India CDSCO

Written by Anmol Singh

10 September 2023

The Central Drugs Standard Control Organization (CDSCO) is the apex body in India that oversees the production and import of medical devices, including nebulizers. To either manufacture or import a nebulizer in India, a specific license, commonly referred to as the CDSCO license, is mandatory.

Which license is needed for importing Nebulisers in India?

If you’re looking to import nebulizers into the Indian market, you’ll need to obtain a license on Form MD 15. This permission is granted by the CDSCO headquarters located in New Delhi.

Which license is needed for manufacturing Nebulisers in India?

For those interested in manufacturing nebulizers within the country, a license on Form MD 9 from CDSCO is essential.

Is repacking of nebulizers considered manufacturing in India?

Repackaging of medical devices, including nebulizers, is considered manufacturing as per the Drugs and Cosmetics Act. Hence, if you’re repackaging the device in your own branding, you’ll need to secure a manufacturing license on Form MD 9.

What is the risk class of Nebulisers?

Nebulizers have been classified as a Class C medical device as per the notification number 29/Misc/3/2017-DC (292) dated 15.05.2019. Their primary use is to administer medications in mist form for respiratory disorders.

What are the different types of Nebulisers?

  • Piston Nebulizers: Also known as jet nebulizers, these devices administer liquid medication as a mist to the respiratory tract. They consist of a compressor, a nebulizing chamber, and a mouthpiece or mask. They are widely used for conditions like asthma and COPD.
  • Mesh Nebulizers: These are compact devices that use a vibrating mesh to produce a fine mist from liquid medication. They are battery-operated, making them convenient for travel, and are quieter and faster than piston nebulizers.

What is the Government Fees for Nebulizer Import License?

For those importing nebulizers, the government fee for an MD 15 License is $3000 for the site and an additional $1500 per product.

What is the Government Fees for Nebulizer Manufacturing License?

To manufacture a nebulizer, the government fee for the MD 9 license is ₹50,000 for every manufacturing site and an added ₹1000 per product.

How to get the manufacturing license for Nebulizers on form MD 9 from CDSCO?

To secure a manufacturing license on Form MD 9, you must first apply for a test license for manufacturing test batches of the nebulizer on Form MD 12. Once permission is granted, three test batches of the nebulizer must be manufactured and sent for lab testing. After receiving the test reports, you can apply for the manufacturing license on Form MD 7 via the CDSCO portal. The application will be reviewed by drug inspectors, followed by an audit. Once all requirements are met, the license will be granted on Form MD 9.

How to get an import license for Nebulizers on form MD 15 from CDSCO?

To import a nebulizer, you need to apply on Form MD 14 via the CDSCO portal. After submitting the necessary documents, medical device officers from the CDSCO headquarters will review your application. Once they are satisfied, the license will be granted on Form MD 15.

What are the technical persons required for manufacturing Nebulizers?

As mandated by CDSCO, individuals involved in the manufacturing and testing of nebulizers should either have qualifications in Btech, BSc, or B Pharma with 2 years of experience or possess a diploma in any of the mentioned fields with 4 years of experience.

How much time does it take to get the license for manufacturing or importing Nebulisers in India?

Currently, obtaining an MD 15 license for a nebulizer takes approximately 3 to 4 months. For an MD 9 license, the process takes around 3 months.

How Pharmadocx Consultants Can Assist in Nebulizer Licensing

Navigating the intricate pathways of CDSCO licensing can be challenging. With Pharmadocx Consultants by your side, you can simplify this complex process. Our team, with its deep understanding of the regulatory landscape, offers comprehensive support, ensuring that you meet all CDSCO requirements for nebulizer manufacturing or import. Let us handle the licensing intricacies so you can focus on delivering quality healthcare products.
Looking to venture into the nebulizer market in India? Let Pharmadocx Consultants be your guiding light. Contact us today!

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