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CDSCO Manufacturing License for Pliable-polymer dental regeneration membrane, bio absorbable, tacked

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is the pivotal drug regulatory authority in India. The CDSCO functions under the Ministry of Health and Family Welfare, Government of India. The chief responsibilities of the CDSCO include ensuring quality in drugs, cosmetics and medical devices, and regulating clinical trials in India. In addition, they enforce standards and guidelines for producing and singing pharmaceuticals in the interest of the public. Manufacturing licenses play a key role in the medical device industry, regulating the production and ensuring quality and safety of the medical devices.

One such device is the Pliable-polymer dental regeneration membrane, bioabsorbable, tacked. This medical device has a distinct significance in the field of dentistry and periodontal rehabilitation. It aids in the regeneration of tooth support which might be lost due to periodontal disease or trauma. Here is a link to the CDSCO's portal link where more detailed information can be attained about the regulatory requirements for the manufacture and usage of these medical devices.

What is Pliable-polymer Dental Regeneration Membrane, Bioabsorbable, Tacked?

The Pliable-polymer dental regeneration membrane, bioabsorbable, tacked, commonly referred to as a dental regeneration membrane, is a sterile material used in dental procedures. Its purpose is to aid in the regeneration of tooth support, which can be lost due to periodontal disease or trauma. This dental device acts as a barrier, preventing the down-growth of soft tissue into the underlying bone during the healing period. The uses of this device are majorly in periodontal rehabilitation procedures.

The Role of CDSCO in Medical Device Regulation

The CDSCO plays a vital role in regulating medical devices in India. With their mission to safeguard and enhance public health in India, they provide a comprehensive regulatory framework for medical devices. This framework details the criteria for the licensing of medical devices, their manufacture, sale, import, and the penalties for non-compliance. It is imperative for medical device manufacturers to follow these regulations strictly.

How to Manufacture Pliable-polymer Dental Regeneration Membrane, Bioabsorbable, Tacked?

Given the importance of the Pliable-polymer dental regeneration membrane in dentistry, its manufacturing process needs to adhere strictly to the regulatory compliances set by the CDSCO. The regulations emphasize on maintaining the quality and safety of the device. Failure to comply with these specifications can lead to serious health hazards for the patients and legal consequences for the manufacturers.

Fees for Manufacturing License for Pliable-polymer Dental Regeneration Membrane, Bioabsorbable, Tacked

For a Class C medical device such as the Pliable-polymer dental regeneration membrane, bioabsorbable, tacked, a MD9 license is required. The fees for this license are Rs. 50,000 for the license and Rs. 1,000 per product. You can find more details about the MD9 license here.

Why is a Manufacturing License Necessary for Pliable-polymer Dental Regeneration Membrane, Bioabsorbable, Tacked?

A manufacturing license for medical devices is mandatory. This license assures the quality and safety of the products, making sure that the devices are up-to-date with the latest health and safety standards. Earning a license protects consumers and patients from substandard products and unethical business practices. Furthermore, it builds trust between the manufacturer and the consumers by conveying the manufacturer's commitment to quality and safety.

Steps to Obtain a CDSCO Manufacturing License for Pliable-polymer Dental Regeneration Membrane, Bioabsorbable, Tacked

The process to obtain a manufacturing license involves several steps:

  1. Preparing the necessary documentation, which includes Device Master File, Quality Management Certificate, Device Details, Site details etc.
  2. Successfully submitting the application after fulfilling all the prerequisites.
  3. Waiting for the approval of the application from the regulatory body.
  4. Overcoming common challenges like ensuring compliance with guidelines, meeting safety standards and handling the documentation.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Pliable-polymer dental regeneration membrane, bioabsorbable, tacked as per Medical Device Rules, 2017?

  • The risk class of Pliable-polymer dental regeneration membrane, bioabsorbable, tacked is Class C.

Q2. What license is needed to manufacture a Pliable-polymer dental regeneration membrane, bioabsorbable, tacked?

  • The license needed to manufacture a Pliable-polymer dental regeneration membrane, bioabsorbable, tacked is MD9.

Q3. What is the fee for the MD9 license for Pliable-polymer dental regeneration membrane, bioabsorbable, tacked?

  • The fee for the MD9 license is Rs. 50,000 and Rs. 1,000 per product.

Q4. Who will issue the manufacturing license for Pliable-polymer dental regeneration membrane, bioabsorbable, tacked?

  • For Class C devices, the CDSCO HQ in New Delhi will issue the license.

Q5. Is repackaging of Pliable-polymer dental regeneration membrane, bioabsorbable, tacked considered manufacturing?

  • Yes. As per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing and by further definitions, medical devices are also drugs. Repackaging of Pliable-polymer dental regeneration membrane, bioabsorbable, tacked requires a license on MD9.

Conclusion

Regulatory processes can be complex and tedious. However, these processes are put in place to ensure that patients receive safe and effective medical devices. Hence, understanding and complying with the regulatory standards is essential for manufacturing medical devices.

If you still have questions or need further clarification with regards to getting a CDSCO manufacturing license, we at Pharmadocx consultants are here to help. We specialize in assisting individuals and businesses navigate the licensing process and educate them about the devices they handle and manufacture. Feel free to reach out to us for a consultation or for assistance with your licensing process. You can call us at +91-7404557227 or email us at [email protected]. Your journey to becoming a licensed medical device manufacturer is just a call or an email away.

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