Published on

CDSCO Manufacturing License for Sterile Surgical probe

Authors
  • avatar
    Name
    CDSCO Licenses Blog
    Twitter

Introduction

The Central Drugs Standard Control Organization (CDSCO) is at the helm ensuring the quality, efficacy and safety in the manufacture and sale of drugs and medical devices in India. As the national regulatory body, CDSCO is instrumental in managing the process of setting standards for medical products, granting licenses, and regulating clinical trials. One critical facet of its workings pertains to the manufacturing licenses for medical devices.

In the medical device industry, having a valid manufacturing license is crucial. It not only ensures compliance with the regulatory policies but also safeguards the quality and safety standards of the products thus protecting the patients and consumers.

In this blog, we focus on the Sterile Surgical Probe. A key medical device used for exploring wounds, sinuses, fistulas, and cavities. The Sterile Surgical Probe carries significant importance in the operation theaters and its manufacturing is highly regulated to ensure its performance and safety.

For more details, visit CDSCO's portal here

What is a Sterile Surgical Probe?

A Sterile Surgical Probe is a medical device. It's a slim, sterile medical instrument used mostly in surgical procedures to examine accessible body cavities, wounds, sinuses, and fistulas. It allows a doctor to examine a wound, detect foreign bodies and guide in minor surgeries.

Common usage of the Sterile Surgical Probe is in operation theaters during surgeries for probing wounds and directing treatment.

The Role of CDSCO in Medical Device Regulation

CDSCO has a multifaceted role as the regulatory authority for drug and medical devices in India. With the mandate to safeguard public health, the organization oversees the manufacturing, import, and distribution of drugs and medical devices through the enforcement of the Drugs and Cosmetics Act.

The regulatory framework for medical devices by CDSCO classifies these devices into four risk classes - A, B, C, and D. Risk Class B to which the Sterile Surgical Probe belongs, requires manufacturing license - MD5.

How to manufacture a Sterile Surgical Probe

The manufacture of the Sterile Surgical Probe requires adherence to stringent protocols set by CDSCO to ensure product safety and efficacy. The manufacturing process is regulated by the acquired license, in this case, the MD5 license.

Fees for Manufacturing License for Sterile Surgical Probe

The applicable licensing fee for manufacturing Sterile Surgical Probe that falls under category B is for MD5. The fee for MD5 license is Rs. 5,000 and Rs. 500 per product.

Why is a Manufacturing License Necessary for a Sterile Surgical Probe?

Acquiring a manufacturing license mandated by CDSCO is compulsory. The license is key to quality control, ensuring safety in the production cycle of medical devices. Compliance with regulatory norms is crucial as it guarantees the devices meet the required health and safety standards. Regulatory compliance plays a vital role in protecting patients and consumers from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Sterile Surgical Probe

  1. Prepare necessary documentation including complete Device Master File, Quality Management Certificate, Device Details, and Site Details.
  2. Submit your application and supporting documents.
  3. Patiently wait for approval from the authority.
  4. Be ready to face and overcome any challenges during the process.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of a Sterile Surgical Probe as per Medical Device Rules, 2017?
Risk class of Sterile Surgical Probe is Class B.

Q2. What license is needed to manufacture a Sterile Surgical Probe?
For manufacturing Sterile Surgical Probe, MD5 license is required.

Q3. What is the fee for the MD5 license for a Sterile Surgical Probe?
The fee for MD5 license is Rs. 5,000 and Rs. 500 per product.

Q4. Who will issue a manufacturing license for a Sterile Surgical Probe?
The manufacturing license for Class B medical devices like the Sterile Surgical Probe will be issued by the state FDA.

Q5. Is repackaging of a Sterile Surgical Probe considered manufacturing?
Yes. As per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of medical devices is considered manufacturing. Hence, repackaging of a Sterile Surgical Probe requires a MD5 license.

Conclusion

Being aware of the regulatory requirements for manufacturing medical devices and practicing compliance are major responsibilities in the medical sector. Pharmadocx Consultants is happy to assist you in acquiring your manufacturing license and guide you throughout the process.

Don't hesitate to reach out to us for consultation or assistance regarding the licensing process at Pharmadocx Consultants, or call us at +91-7404557227, or email us at [email protected].

And for further information on the MD5 license, refer to this article.

cdsco import license in india banner
cdsco manufacturing license in india banner