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Obtain MD 6 Loan License for Medical Device Manufacturing

Start your Medical Device Manufacturing Journey with Our Expert-Curated Guide to Securing an MD 6 Loan License: Uncover Essential Steps, Considerations, and Strategies for Seamless Compliance and Licensing Procedure.

MD 6 Loan License: Everything You Need to Know

An MD 6 Loan License is a mandatory authorization required for medical device manufacturers who intend to manufacture Class A or Class B Medical Devices and In-Vitro Diagnostic Devices on a loan premises.

The applicant has to file the application on Form MD 4 to the State Licensing Authority (SLA) along with the mandatory documents. After verification, the SLA issues MD 6 Loan License to ensure the quality and safety of medical devices being produced.

Who Needs an MD 6 Loan License?

Any medical device manufacturer who wants to utilize the manufacturing facilities of another licensed manufacturer to produce Class A or Class B Medical Devices and In-Vitro Diagnostic Devices requires an MD 6 Loan License. This license allows manufacturers to expand their production capabilities without the need to invest in a dedicated manufacturing facility.

Benefits of an MD 6 Loan License

Obtaining an MD 6 Loan License offers several benefits to medical device manufacturers, including:

Expanded Production Capacity:

Manufacturers can increase their production capacity without the need for significant capital investment.

Reduced Costs:

Utilizing existing manufacturing facilities can lead to reduced production costs compared to establishing a new facility.

Faster Time to Market:

Manufacturers can bring their products to market more quickly by leveraging existing infrastructure.

Step-by-Step Guide to MD 6 Loan License Application

Step #1 User registration on SUGAM Portal of CDSCO:

Register your organization on CDSCO’s SUGAM Portal. An undertaking, Identity proof, Address Proof is required to get register.

Step #2 Fill out the Application Form MD-4:

Fill in the application Form MD 4. List your devices which you want to manufacture. Device Generic Name, Trade Name, Description, Intended Use, Shelf Life, Storage condition, Model Number, etc. are required to be filled.

Step #3 Upload the Mandatory Documents:

Upload the necessary documents like the site master file, device master file, MD 5 License copy of the actual manufacture.

Step #4 Pay the Fee:

  • MD 6 Loan License: ₹5,000
  • Per Distinct Medical Device: ₹500

Step #5 Scrutiny of Loan license Application:

Your application will be scrutinized by the State Licensing Authority. The SLA may ask for further supporting documents.

Step #6 Audit by Notified Body:

The loan license application will be proceed to a quality management system compliance audit if it meets the requirements. Your premises will be audited by an independent notified body approved by the CDSCO. If any Non-Conformance (NC) is identified, you will be required to submit an NC closure report.

Step #7 Approval of MD-5 License:

Once all the conditions are met, the state licensing authority will grant the MD 6 Loan License to manufacture Class A or Class B Medical Devices.

Mandatory Documents for MD 6 Loan License

In accordance with Medical Device Rules, 2017, the applicant must apply for the MD 6 Loan License with the following mandatory documents:

Validity and Renewal of Loan License

Upon issuance, the MD 6 Loan License remain valid for perpetual, depending on the timely payment of the retention fee every five years.

Timeline to get Loan License

It can take 3 to 6 months to get MD 6 Loan License from the state licensing authority.

MedDev Experts: Your One-Stop Solution for MD 6 Loan License Acquisition

At MedDev Experts, we understand the intricacies of the MD 6 Loan License application process and possess the expertise to guide you every step of the way. Our comprehensive range of services includes:

Application Form Preparation:

We assist in completing the complex MD 6 Loan License application form, ensuring that all required information is accurately and comprehensively provided.

Document Compilation and Review:

We meticulously gather and review all necessary supporting documents, including site master files, device master files, and quality control procedures, ensuring compliance with regulatory requirements.

Expert Guidance and Representation:

Our team of experienced regulatory professionals provides expert guidance throughout the application process, representing your interests and advocating for your success.

Why Choose MedDev Experts?

MedDev Experts distinguishes itself from other medical device consulting companies through our unwavering commitment to:

Industry Expertise:

Our team comprises seasoned professionals with extensive knowledge of the Indian medical device regulatory framework, ensuring that your application is handled with the utmost expertise.

Unparalleled Customer Focus:

We prioritize building strong relationships with our clients, providing personalized attention and tailored solutions to address their specific needs.

Proven Track Record:

Our consistent success in securing the Loan Licenses for our clients speaks volumes about our commitment to excellence and our in-depth understanding of regulatory requirements.

Contact MedDev Experts for your Loan License

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