CDSCO Manufacturing License for Hand dynamometer/pinch meter, electronic

Introduction

The Central Drugs Standard Control Organization (CDSCO) plays an instrumental role in ensuring the safety and efficacy of medical devices available for use in India. It is the national regulatory body for Indian pharmaceuticals and medical devices, much like the FDA in the United States. CDSCO governs the quality of drugs and medical devices through stringent regulations, granting licenses for the manufacturing of these products.

In the medical device industry, manufacturing licenses play a crucial role to ensure patient safety. Manufacturing an unregulated or unlicensed medical device can lead to severe harm or even fatalities. Thus, it is essential to abide by the regulations set by regulatory bodies like the CDSCO.

In this context, one such crucial medical device is the Hand dynamometer/pinch meter, electronic. This device plays a significant role in patient rehabilitation processes by assessing neuromuscular functions.

For more related information, you can refer to CDSCO's portal here

• What is Hand dynamometer/pinch meter, electronic?
• The Role of CDSCO in Medical Device Regulation
• How to Manufacture Hand dynamometer/pinch meter, electronic
• Fees for Manufacturing License for Hand dynamometer/pinch meter, electronic
• Why is a Manufacturing License Necessary for Hand dynamometer/pinch meter, electronic?
• Steps to Obtain a CDSCO Manufacturing License for Hand dynamometer/pinch meter, electronic
• Frequently Asked Questions (FAQs)
• Conclusion

What is Hand dynamometer/pinch meter, electronic?

A Hand dynamometer/pinch meter, electronic, is a medical device that assesses neuromuscular functionality. It measures the force or power exerted by the hand and forearm muscles when squeezing or pinching an object. These devices are commonly used during rehabilitation processes, especially for patients recovering from conditions that have affected their hand strength and motor functions.

The Role of CDSCO in Medical Device Regulation

The Central Drugs Standard Control Organization (CDSCO) has a long history of protecting the health and wellbeing of Indian citizens. Their mission is to safeguard and enhance public health by ensuring the safety, efficacy, and quality of drugs, cosmetics and medical devices.

CDSCO's regulatory framework for medical devices is highly structured and comprehensive. It categorizes medical devices into four risk levels - class A, B, C, and D - with class A being the lowest risk and class D being the highest. The Hand dynamometer/pinch meter, electronic, falls under class B.

How to Manufacture Hand dynamometer/pinch meter, electronic

The process of manufacturing a Hand dynamometer/pinch meter, an electronic requires strict adherence to regulations laid down by CDSCO. The manufacturing process should align with the guidelines to ensure the safety and quality of the product.

Fees for Manufacturing License for Hand dynamometer/pinch meter, electronic

For a class B medical device, such as Hand dynamometer/pinch meter, an electronic, MD5 is required. The fee for obtaining the MD5 license is Rs. 5,000, and for each product manufactured, an additional fee of Rs. 500 is charged.

Why is a Manufacturing License Necessary for Hand dynamometer/pinch meter, electronic?

Obtaining a manufacturing license for medical devices, including Hand dynamometer/pinch meter, electronic is a mandatory requirement. It ensures quality and safety in medical device production.

Manufacturing licenses also serve as a regulatory compliance in the healthcare sector, thereby protecting consumers and patients from potentially harmful products. These licenses ensure that the medical devices manufactured are under strict quality parameters specified by regulatory bodies like CDSCO.

Steps to Obtain a CDSCO Manufacturing License for Hand dynamometer/pinch meter, electronic

Obtaining a manufacturing license requires the submission of several documents, including the Device Master File, Quality Management Certificate, Device Details, Site details, etc. The application process is straightforward, beginning with submission and ending with approval. However, there may be common challenges encountered during the process. But, rest assured, advice and guidance can help overcome these challenges. For more details, please refer to this article

Frequently Asked Questions (FAQs)

1. What is the risk class of the Hand dynamometer/pinch meter, electronic as per Medical Device Rules, 2017?

   The risk class for Hand dynamometer/pinch meter, electronic is class B.

2. What license is needed to manufacture Hand dynamometer/pinch meter, electronic?

   An MD5 license is required to manufacture Hand dynamometer/pinch meter, electronic.

3. What is the fee for the MD5 license for Hand dynamometer/pinch meter, electronic?

   The fee for obtaining the MD5 license is Rs. 5,000 with an additional fee of Rs. 500 for each product manufactured.

4. Who will issue the manufacturing license for Hand dynamometer/pinch meter, electronic?

   The manufacturing license for class B devices like Hand dynamometer/pinch meter, electronic is issued by the state FDA.

5. Is repackaging of Hand dynamometer/pinch meter, electronic considered manufacturing?

   Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. Medical devices also fall under the category of drugs as per the Act. Hence, repackaging of Hand dynamometer/pinch meter, electronic is also considered manufacturing requiring an MD5 license.

Conclusion

If you're looking into manufacturing the hand dynamometer/pinch meter, electronic or any other medical=device, obtaining the necessary licenses is integral to the process. For a consultation or assistance regarding the licensing process, reach out to Pharmadocx Consultants, call them at +91-7404557227, or email them at [email protected].