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CDSCO Manufacturing License for Membrane fixation tack, bio absorbable

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Introduction

In the ever-evolving medical industry, regulatory authorities play a pivotal role to keep everything in check. The Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health & Family Welfare, has various responsibilities including the regulation of medical devices (manufacture, sale, distribution) in India.

Manufacturing licenses are significant in the medical device industry as they assure consumers of the quality and safety of these products. In India, the medical device named 'Membrane fixation tack, bio-absorbable' serves a significant purpose in dental care and, like all other medical devices, requires a manufacturing license as per CDSCO regulations.

Before we delve deeper into the specifics of the CDSCO manufacturing license for this device, you can find more information about CDSCO and its regulatory guidelines on their official portal here.

What is Membrane fixation tack, bio-absorbable?

This medical device is essentially a sterile bio-absorbable tack. Its primary purpose is to fix a pliable-polymer dental regeneration membrane in place to aid in the regeneration of tooth support. This is commonly lost due to periodontal disease or trauma. The device is indispensable in dental surgeries, especially those dealing with periodontal complications.

The Role of CDSCO in Medical Device Regulation

CDSCO, in addition to its other responsibilities, is charged with regulating the manufacture of medical devices in India. The organization oversees the licensing, compliance, and surveillance of these devices to ensure that standards are met and maintained. One critical aspect of this regulatory activity is the risk-based classification of medical devices, dictating the manufacturing license requirements.

How to manufacture Membrane fixation tack, bio-absorbable

Manufacturing of such specialized medical devices requires a strict adherence to regulatory guidelines, ensuring safety and efficacy. Manufacturing activities might involve material sourcing, design and development, rigorous testing, sterilization and packaging.

Fees for manufacturing license for Membrane fixation tack, bio-absorbable

As per the risk class 'C', the license required for the manufacturing of Membrane fixation tack, bio-absorbable is MD9. The fees for MD9 license is Rs. 50,000 for the license and Rs. 1,000 per product.

Why is a Manufacturing License Necessary for Membrane fixation tack, bio-absorbable?

Acquiring a manufacturing license is non-negotiable for all manufactured medical devices. This ensures:

  • Quality and safety in medical device production
  • Regulatory compliance which is crucial in the healthcare sector
  • Consumer and patient protection from substandard products

Steps to Obtain a CDSCO Manufacturing License for Membrane fixation tack, bio-absorbable

Obtaining a CDSCO manufacturing license involves the following steps:

  • Gathering required documentation (like Device Master File, Quality Management Certificate, Device Details, Site details)
  • Submitting the application with necessary documentation
  • Going through the approval process
  • Overcoming common challenges -

For further details, please visit the following link - CDSCO MD9 manufacturing license

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Membrane fixation tack, bio-absorbable as per Medical Device Rules, 2017?

The risk class of Membrane fixation tack, bio-absorbable is Class 'C'.

Q2. What license is needed to manufacture Membrane fixation tack, bio-absorbable?

The license required to manufacture Membrane fixation tack, bio-absorbable is MD9.

Q3. What is the fee for MD9 license for Membrane fixation tack, bio-absorbable?

For MD9 license, it is Rs. 50,000 for the license and Rs. 1,000 per product.

Q4. Who will issue the manufacturing license for Membrane fixation tack, bio-absorbable?

For class C devices like, Membrane fixation tack, bio-absorbable, CDSCO HQ in New Delhi will issue the license.

Q5. Is repackaging of Membrane fixation tack, bio-absorbable considered manufacturing?

Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing and by further definitions, medical devices are also drugs. Medical Device Rules have been made under the provisions of Drug Act only and hence repackaging of Membrane fixation tack, bio-absorbable is also considered manufacturing requiring a license on MD9.

Conclusion

If you are facing any challenges in obtaining a CDSCO manufacturing license, we at Pharmadocx Consultants are always ready to assist. We are experienced in helping numerous businesses navigate the regulatory complexities. Feel free to email us at [email protected], call us at +91-7404557227, or visit our website here. Your business goals are paramount to us, and we believe in doing everything in our capacity to help you realize them.

These regulations are made to ensure only high-quality and efficient medical devices reach consumers. They might seem daunting at first, but with the right guidance and assistance, they can become a smooth part of your business operations.

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