What is a CDSCO Loan License?
A CDSCO Loan License, as per the Drug and Cosmetic Act of 1940, refers to a license granted by the licensing authority to an applicant without a production facility or production arrangements but to utilize necessary manufacturing facilities.
The Ministry of Health and Family Welfare (MoHFW) and the CDSCO have established regulations under the Medical Devices Act of 2017. These regulations are designed to ensure that only medical devices meeting quality and safety standards are utilized within the healthcare sector. Additionally, the regulations categorize medical devices based on the risks they present, ensuring patients have access to safe and high-quality medical equipment.
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Furthermore, the regulations mandate manufacturers and importers to register and obtain licenses for manufacturing. Should a manufacturer require financial assistance, they must complete MD-4 and MD-8 forms to apply for a medical device loan license. This article provides insights into the process and significance of medical device loan licenses in India.
Know more about the CDSCO import license
What Are Important Forms for CDSCO Loan License for Medical Devices?
S No. | Description | Approval Form |
1 | Loan License for Class A or Class B medical device | MD-6 |
2 | Loan license to manufacture Class C or Class D medical device | MD-10 |
Know more about CDSCO Classification for Medical Devices
Why Do Manufacturers Option for the Loan License Pathway?
- It can assist manufacturers in navigating regulatory hurdles, thereby reducing the investment needed to enter the Indian market significantly.
- This is particularly beneficial for manufacturers facing constraints due to insufficient production capacity.
Which Authorities Are Responsible for Granting the Medical Device Loan License?
Loan License Authorization for Manufacturing Class A and B Medical Devices
Manufacturers of low- and moderate-risk medical devices aiming to acquire loan licenses for producing Class A and B devices must submit their applications to the SLA (State Licensing Authority). This submission should be done through an online portal using Form MD-4, along with payment of a processing fee for the license granting process for manufacturing, selling, or distributing Class A or Class B medical devices. Approval of the application will be communicated through Form MD-6.
Loan License Authorization for Manufacturing Class C and D Medical Devices
Manufacturers of high-risk medical devices seeking licenses to produce Class C and D devices must apply to the CLA (Central Licensing Authority). This application process is conducted through an online portal using Form MD-8, accompanied by payment of a processing fee for the license issuance. Approval of the application will be communicated through Form MD-10. Within sixty (60) days of applying for a license to manufacture Class C or D medical devices, medical device officers are required to inspect the production facility.
Validity of Loan Licenses
The validity of loan licenses granted for Class A, B, C, and D medical devices remains indefinite, contingent upon the payment of the license maintenance fee prior to the expiration of the five (05)-year period from the date of issuance, unless suspended or revoked by the SLA/CLA.
Documents Needed for CDSCO Loan License
Important documents required for medical device CDSCO loan license.
- Device Master File
- Site Master File
- QMS Documents
- Manufacture License
Unlock the Gateway to CDSCO Loan Licenses for Medical Devices
How Will Operon Strategist Help?
Operon Strategist is a leading medical device regulatory consulting firm renowned for its expertise in assisting clients in obtaining CDSCO loan licenses for medical devices. With a dedicated team of regulatory experts, Operon Strategist navigates the complex regulatory landscape to streamline the process of acquiring CDSCO loan licenses. Their comprehensive services include guiding clients through the application process, ensuring compliance with all necessary documentation, and providing ongoing support to facilitate successful license acquisition. Operon Strategist’s commitment to excellence and in-depth understanding of regulatory requirements make them a trusted partner for companies seeking CDSCO loan licenses for medical devices.
