- Published on
CDSCO Manufacturing License for Dialysis apheresis unit, Therapeutic
- Authors
- Name
- CDSCO Licenses Blog
Introduction
The Central Drugs Standard Control Organization (CDSCO) is the central regulatory body responsible for drug and medical device regulation in India. Tasked with ensuring the quality and safety of these products, CDSCO is instrumental in protecting public health across the country. Manufacturing licenses are core to this, as they ensure only devices of the highest standard are produced and put into the market.
In this regulatory landscape, the Dialysis apheresis unit, a therapeutic medical device, occupies a pivotal role. This unit has transformed nephrology and renal care, offering a lifeline to patients with kidney history. Visit CDSCO's portal for further information.
- What is a Dialysis Apheresis Unit?
- The Role of CDSCO in Medical Device Regulation
- How to manufacture a Dialysis Apheresis Unit
- Fees for manufacturing license for a Dialysis Apheresis Unit
- Why is a Manufacturing License Necessary for a Dialysis Apheresis Unit?
- Steps to Obtain a CDSCO Manufacturing License for a Dialysis Apheresis Unit
- Frequently Asked Questions (FAQs)
- Conclusion
What is a Dialysis Apheresis Unit?
A dialysis apheresis unit is a medical device specifically designed to filtrate blood, separate plasma, and extract specific substances in the plasma like LDL-cholesterol. The plasma is subsequently passed through the filtration column in the device, and the specific substances recombined with various substrates are extracted. This innovative unit is commonly used in nephrology and renal care procedures.
The Role of CDSCO in Medical Device Regulation
Over the years, CDSCO has established itself as a key player in medical device regulation. The organization's mission is to safeguard public health by ensuring the quality, efficacy, and safety of drugs and medical devices. For medical devices, this entails a robust regulatory framework that encompasses device classification, standards, and licensing.
How to manufacture a Dialysis Apheresis Unit
To manufacture a Dialysis Apheresis Unit, one must adhere to the CDSCO guidelines and acquire the appropriate license.
Fees for manufacturing license for a Dialysis Apheresis Unit
For a Class C device like the Dialysis Apheresis Unit, the required license is MD9. The license fee is Rs. 50,000 and an additional Rs. 1,000 per product.
Why is a Manufacturing License Necessary for a Dialysis Apheresis Unit?
A manufacturing license is requisite for a Dialysis Apheresis Unit to guarantee its quality and safety. This compliance with regulatory standards in the healthcare sector safeguards patients from substandard products, improving overall healthcare quality.
Steps to Obtain a CDSCO Manufacturing License for a Dialysis Apheresis Unit
Steps include having the necessary documentation (Device Master File, Quality Management Certificate, Device Details, Site details etc.). The application process consists of submission, review, and approval stages. Common hurdles in the process can be overcome with adequate preparation and guidance.
Frequently Asked Questions (FAQs)
Q1. What is the risk class of a Dialysis Apheresis Unit as per Medical Device Rules, 2017?
The Dialysis Apheresis Unit is a Class C device.
Q2. What license is needed to manufacture a Dialysis Apheresis Unit?
The required license for manufacturing a Dialysis Apheresis Unit is MD9.
Q3. What is the fee for an MD9 license for a Dialysis Apheresis Unit?
The fee for an MD9 license for a Dialysis Apheresis Unit is Rs. 50,000 for the license and Rs. 1,000 per product.
Q4. Who will issue the manufacturing license for a Dialysis Apheresis Unit?
The manufacturing license for a Dialysis Apheresis Unit will be issued by CDSCO HQ in New Delhi.
Q5. Is repackaging of a Dialysis Apheresis Unit considered manufacturing?
Yes, under the Drugs and Cosmetics Act's definition of manufacturing, repackaging of a Dialysis Apheresis Unit is considered manufacturing, requiring an MD9 license.
Conclusion
Navigating the regulatory landscape and licensing process can be overwhelming. Don't hesitate to reach out to Pharmadocx Consultants for a hassle-free experience. You can reach us at "+91-7404557227" or email us at "[email protected]". For a comprehensive overview of MD9 licensing, you can refer to this article.
