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CDSCO Manufacturing License for Cranial perforator
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- CDSCO Licenses Blog
Introduction
The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. Medical devices are of prime importance in the healthcare field, with a significant impact on patient health and safety. Manufacturing licenses serve as a crucial checkpoint supporting quality assurance and security measures before devices enter the market.
Today, we are focusing on a key medical device used in neurology - the Cranial Perforator. Utilized in neurosurgical procedures for cutting sections of the skull, the Cranial Perforator holds significant medical value. You can learn more about the regulatory requirements and the licensing process via the CDSCO's online portal here.
- What is Cranial Perforator?
- The Role of CDSCO in Medical Device Regulation
- How to manufacture Cranial Perforator
- Fees for manufacturing license for Cranial Perforator
- Why is a Manufacturing License Necessary for Cranial Perforator?
- Steps to Obtain a CDSCO Manufacturing License for Cranial Perforator
- Frequently Asked Questions (FAQs)
- Conclusion
What is Cranial Perforator?
A Cranial Perforator is a metallic rotating endpiece aimed at cutting holes or round sections of the skull. By attaching to a powered drill or handpiece, it performs a critical function in neurological surgeries. Its prime uses revolve around neurosurgical procedures, particularly those requiring access into the cranial cavity through the skull.
The Role of CDSCO in Medical Device Regulation
Established to safeguard and enhance public health in India, CDSCO's fundamental mission is to ensure the quality, safety, and efficacy of drugs, cosmetics, and medical devices in the country. Their regulatory framework for medical devices includes the classification of devices based on their risk profile, licensing, post-market surveillance, device recalls, and adverse event reporting mechanisms.
How to manufacture Cranial Perforator
The manufacturing of a Cranial Perforator involves the application of medical, engineering, and technical skills. Since the Cranial Perforator is a Class B device as per the regulations of CDSCO, it requires an MD5 license for manufacturing.
Fees for manufacturing license for Cranial Perforator
Based on the risk classification, the fees for an MD5 license would apply to the Cranial Perforator, which amounts to Rs. 5,000 for the license and a per product fee of Rs.500.
Why is a Manufacturing License Necessary for Cranial Perforator?
The manufacturing license is not only a legal requirement but also a tool to assure the quality and safety of medical devices like the Cranial Perforator. Regulatory compliance forms a cornerstone in the healthcare sector. It helps safeguard consumers and patients from devices that lack satisfactory levels of quality, safety, and efficacy.
Steps to Obtain a CDSCO Manufacturing License for Cranial Perforator
Among the prerequisites are the preparation of the Device Master File, acquisition of the Quality Management Certificate, provision of the specific device details, and identification of the manufacturing site.
The process entails four key steps – submission of the application, review by regulatory authorities, responding to queries and requests for additional information, and finally, obtaining the approval.
Link to MD5 license here.
Frequently Asked Questions (FAQs)
Q.1. What is the risk class of Cranial Perforator as per Medical Device Rules, 2017?
The Cranial Perforator is classified as a Class B device under the Medical Device Rules, 2017.
Q.2. What license is needed to manufacture the Cranial Perforator?
The manufacturing of a Cranial Perforator requires an MD5 license.
Q.3. What is the fees for an MD5 license for the Cranial Perforator?
The fees for an MD5 license for a Cranial Perforator are Rs. 5,000 for the license and Rs. 500 per product.
Q.4. Who will issue the manufacturing license for Cranial Perforator?
For Class B devices like the Cranial Perforator, the state FDA will issue the license.
Q.5. Is repackaging of Cranial Perforator considered manufacturing?
Yes, as per the 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 the Drug Act and hence repackaging of Cranial Perforator is also considered manufacturing requiring an MD5 license.
Conclusion
Understanding the licensing process and regulatory requirements is of supreme importance in the healthcare sector. For further consultation or assistance on the CDSCO manufacturing license you can reach out here - Pharmadocx Consultants, or directly contact us on +91-7404557227 or email us at [email protected].
