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CDSCO Manufacturing License for Probiotic oropharyngeal mucosa dressing

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Introduction

The Central Drugs Standard Control Organisation (CDSCO) is India's primary national regulatory body for the pharmaceuticals and medical devices sector. CDSCO is a part of the Ministry of Health and Family Welfare, Government of India, responsible for laying down the standards and ensuring the quality, efficacy, and safety of drugs, cosmetics, and medical devices in the country. The responsibilities of CDSCO are to enforce the Drugs and Cosmetics Act, regulate the medical devices sector, and issue licenses for medical device manufacturing and importation.

Manufacturing licenses play a crucial role in the medical device industry as they ensure that medical devices produced are reliable, safe, and effective for patient use. Adhering to manufacturing regulations and having the necessary licenses is critical in maintaining the quality, safety, and efficacy of medical devices.

In this blog post, we will specifically look into the manufacturing license for a Probiotic Oropharyngeal Mucosa Dressing, a medical device that plays a significant role in gastroenterology.

To learn more about CDSCO, you can visit their official portal via this link.

What is a Probiotic Oropharyngeal Mucosa Dressing?

A Probiotic Oropharyngeal Mucosa Dressing is a non-sterile substance that is applied to the mucosa of the mouth and pharynx. This dressing facilitates the colonization of saprophytic microflora within the oral cavity or pharynx, typically following antibiotic therapy, bacterial infection, or injury. The dressing includes probiotic bacteria like Streptococcus salivarius and Streptococcus oralis, and compounds that create a barrier to facilitate the growth of the probiotic bacteria.

The Role of CDSCO in Medical Device Regulation

The CDSCO plays an instrumental role in the regulation of medical devices in India. The mission of CDSCO is to safeguard and enhance public health by assuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices. The regulatory framework of CDSCO for medical devices is based on risk-based categorization, which is classified from low risk (Class A) to high risk (Class D).

How to Manufacture a Probiotic Oropharyngeal Mucosa Dressing

The manufacturing of Probiotic Oropharyngeal Mucosa Dressing requires adherence to CDSCO guidelines, and obtaining the required manufacturing license - MD9 in this case.

Fees for Manufacturing License for Probiotic Oropharyngeal Mucosa Dressing

The license required to manufacture Probiotic Oropharyngeal Mucosa Dressing is MD9. The fees for MD9 are Rs. 50,000 for the license and Rs. 1,000 per product.

Why is a Manufacturing License Necessary for Probiotic Oropharyngeal Mucosa Dressing?

It is mandatory to obtain a manufacturing license to ensure quality and safety in the production of medical devices. Compliance with regulatory requirements is crucial in the healthcare sector to protect consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Probiotic Oropharyngeal Mucosa Dressing

In order to get a CDSCO manufacturing license, there are several steps and requirements:

  1. Provide Device Master File, Quality Management Certificate, Device Details, Site details, etc.
  2. Submit the application to the correct authority based on the class of the device
  3. Await Approval
  4. Navigate any challenges by consulting with experts

Frequently Asked Questions (FAQs)

Q1: What is the risk class of Probiotic Oropharyngeal Mucosa Dressing as per Medical Device Rules, 2017?

A1: The risk class of Probiotic Oropharyngeal Mucosa Dressing is Class C.

Q2: What license is needed to manufacture Probiotic Oropharyngeal Mucosa Dressing?

A2: The license needed to manufacture Probiotic Oropharyngeal Mucosa Dressing is MD9.

Q3: What is the fees for MD9 license for Probiotic Oropharyngeal Mucosa Dressing?

A3: The fees for MD9 license is Rs. 50,000 for the license and Rs. 1,000 per product.

Q4: Who will issue the manufacturing license for Probiotic Oropharyngeal Mucosa Dressing?

A4: For Class C devices, CDSCO HQ in New Delhi will issue the license.

Q5: Is repackaging of Probiotic Oropharyngeal Mucosa Dressing considered manufacturing?

A5: Yes, according to the Drugs and Cosmetics Act's definition of manufacturing, repackaging is considered manufacturing. Therefore, by further definitions, repackaging of Probiotic Oropharyngeal Mucosa Dressing is also considered manufacturing requiring a license on MD9.

Conclusion

We at Pharmadocx Consultants are committed to assisting you through the licensing process. For further consultation or assistance, feel free to reach out to us at our website https://www.pharmadocx.com. You can also call us directly at +91-7404557227 or email us at [email protected].

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