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CDSCO Manufacturing License for Manual enema device, reusable

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is a central scientific regulatory body in India that regulates the approval of new drugs, clinical trials, pharmaceuticals, and medical devices. A crucial part of CDSCO's responsibility is the issuance of manufacturing licenses, a mandatory requirement in the medical device industry for ensuring consumer safety and consistent product quality.

Today, we'll delve into the details of acquiring a CDSCO manufacturing license for a Class B medical device, specifically a Manual Enema Device. This reusable device plays a significant role in gastroenterology, providing essential relief for patients by physically stimulating peristalsis to facilitate the evacuation of the large intestine.

For more information about the CDSCO and their licensing procedures, visit their official portal here.

What is a Manual Enema Device?

A Manual Enema Device is designed to manually introduce fluid, typically a saline solution, into the rectum. This process expands the lower intestinal tract and stimulates peristalsis, assisting the natural evacuation process of the large intestine.

The device is most commonly used in medical procedures where bowel clearance is necessary, such as pre-operative or pre-diagnostic procedures in the gastroenterology field. Being reusable, this device reduces overall medical waste and costs while maintaining a high level of patient comfort and reliability.

The Role of CDSCO in Medical Device Regulation

The CDSCO has a mission to safeguard and enhance the public health of India. Over the years, it has developed a robust regulatory framework for medical devices, ensuring that the medical products available to Indian consumers are efficient, safe, and compliant with international standards.

For a license to manufacture the Manual Enema Device, a Class B medical device, one would require the MD5 license.

How to Manufacture a Manual Enema Device

Manual Enema Devices should be manufactured adhering to the highest standards of quality and safety, as outlined by CDSCO's rules and regulations. Each device should be individually inspected and tested to ensure it operates as intended and poses no health risks to the patient.

Fees for Manufacturing License for a Manual Enema Device

For a Manual Enema Device, classified as a Class B medical device, the required license is MD5. The fees for the MD5 license are Rs. 5,000 for the license and an additional Rs. 500 per product.

Why is a Manufacturing License Necessary for Manual Enema Device?

Obtaining a CDSCO manufacturing license is a mandatory procedure before manufacturing any medical device in India. The license guarantees that devices are produced under strictly controlled conditions, ensuring their quality and safety for users.

Moreover, manufacturing licenses for a Manual Enema Device assure the public and healthcare providers that the device they use has been produced to the highest standards, preventing the possibility of substandard products entering the market.

Steps to Obtain a CDSCO Manufacturing License for Manual Enema Device

  1. Gather and prepare the necessary documentation, including the Device Master File, Quality Management Certificate, Device Details, Site details, and others.
  2. Submit your application through the CDSCO portal.
  3. Await the evaluation and approval process by the relevant authorities.
  4. Overcome any potential hurdles or objections raised by the authorities with the help of experts and thorough documentation.

It's worth noting that a comprehensive understanding of the licensing procedure, combined with continuous follow-ups, can make the process smoother and faster. Should you face any difficulties, consider seeking professional assistance.

FAQs

Q1. What is the risk class of Manual Enema Device as per Medical Device Rules, 2017?

Manual Enema Device is classified as a class B device as per Medical Device Rules, 2017.

Q2. What license is needed to manufacture Manual Enema Device?

To manufacture a Manual Enema Device, an MD5 license is required.

Q3. What are the fees for the MD5 license for Manual Enema Device?

The fees for the MD5 license are Rs. 5,000 for the license and Rs. 500 per product.

Q4. Who will issue the manufacturing license for Manual Enema Device?

The manufacturing license for Class B devices, such as the Manual Enema Device, will be issued by the state FDA.

Q5. Is repackaging of Manual Enema Device considered manufacturing?

Yes, repackaging of Manual Enema Device is considered manufacturing as per the Drugs and Cosmetics Act's definition of manufacturing. The repackaging of the Manual Enema Device requires a license on MD5.

Conclusion

Obtaining a CDSCO medical device manufacturing license may seem complicated, but with professional assistance from Pharmadocx Consultants, the process can be less daunting. They offer expert guidance through the process and can assist in navigating through the paperwork and regulatory hurdles.

For consultation or assistance, reach out to Pharmadocx Consultants or call directly at +91-7404557227, or email to [email protected].

Additionally, for more details regarding the MD5 license required for manufacturing such Class B medical devices, you can Read this article.

Remember, a successful application relies on thorough preparation, understanding of the process, and keeping up to date with all regulatory changes. Let Pharadocx Consultants guide you on the path to success in the medical device industry.

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