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CDSCO Manufacturing License for Endoscopic electrosurgical biopsy/resection kit, full- thickness

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's primary regulatory body for pharmaceuticals and medical devices. It is a part of the Ministry of Health & Family Welfare, Government of India, responsible for approval of Drugs, Conducting Clinical Trials, Laying down the standards for Drugs, Control over the quality of imported Drugs among many others, to ensure the safety, efficacy and quality of the drugs being sold in Indian market.

Due to the vital role they play in the healthcare sector, manufacturing licenses for medical devices, like the Endoscopic electrosurgical biopsy/resection kit, full- thickness, are of great importance to ensure their safety and efficacy. This kit represents a significant advancement in the medical field, offering an easy and effective means for obtaining full-thickness tissue biopsies and therapeutic resection of gastric, duodenal, colonic, and/or rectal tissue during endoscopic procedures. For more information, you can visit the CDSCO's portal here

What is Endoscopic Electrosurgical Biopsy/Resection Kit, Full- Thickness?

These kits are medical tools that enable doctors to collect full-thickness tissue samples for biopsy or perform therapeutic resection during endoscopic procedures. These procedures are largely used in gastroenterology to diagnose and treat a variety of conditions relating to digestive organs.

The Role of CDSCO in Medical Device Regulation

The CDSCO, in its mission to protect and promote public health in India, has a regulatory framework dedicated to medical devices. The framework varies according to the level of associated risk from Class A (lowest risk) to Class D (highest risk). As per the framework, the Endoscopic Electrosurgical Biopsy/Resection Kit falls under Class C.

How to Manufacture Endoscopic Electrosurgical Biopsy/Resection Kit, Full- Thickness

Taking into consideration the risk level (Class C), the license required for manufacturing the Endoscopic Electrosurgical Biopsy/Resection Kit is MD9.

Fees for Manufacturing License for Endoscopic Electrosurgical Biopsy/Resection Kit, Full- Thickness

The fees for the MD9 license are Rs. 50,000, with an additional Rs. 1,000 per product. For more detailed information on MD9 licensing, you can visit here

Why is a Manufacturing License Necessary for Endoscopic Electrosurgical Biopsy/Resection Kit, Full- Thickness?

Obtaining manufacturing license is mandatory before starting the production. Manufacturing without a license can lead to legal repercussions. A license ensures quality and safety in the production of medical devices, protecting consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Endoscopic Electrosurgical Biopsy/Resection Kit, Full- Thickness

  1. Document Preparation - Device Master File, Quality Management Certificate, Device Details, Site details etc.
  2. Application Submission
  3. Review and approval of the application by the regulatory authority
  4. Upon approval, issuance of license

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Endoscopic Electrosurgical Biopsy/Resection Kit, Full- Thickness as per Medical Device Rules, 2017?

  • The risk class is C.

Q2. What license is needed to manufacture Endoscopic Electrosurgical Biopsy/Resection Kit, Full- Thickness?

  • The required license is MD9.

Q3. What is the fees for MD9 license for Endoscopic Electrosurgical Biopsy/Resection Kit, Full- Thickness?

  • The fees for MD9 license are Rs. 50,000, with an additional Rs. 1,000 per product.

Q4. Who will issue the manufacturing license for Endoscopic Electrosurgical Biopsy/Resection Kit, Full- Thickness?

  • The CDSCO HQ in New Delhi will issue the license.

Q5. Is repackaging of Endoscopic Electrosurgical Biopsy/Resection Kit, Full- Thickness 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 Endoscopic Electrosurgical Biopsy/Resection Kit, Full- Thickness is also considered manufacturing requiring a license on MD9.

Conclusion

We hope this article provided you insight on the licensing process for manufacturing medical devices. If you require any further assistance in obtaining a CDSCO manufacturing license, feel free to reach out to Pharmadocx Consultants at "+91-7404557227" or send an email to [email protected].

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