Introduction to CDSCO MD-6 Loan License

The CDSCO MD-6 Loan License is a crucial certification for businesses involved in the manufacturing of Class A and Class B medical devices in India. Issued by the Central Drugs Standard Control Organization (CDSCO) under the Medical Devices Rules (MDR) 2017, this license allows manufacturers to produce medical devices without owning a manufacturing unit. Instead, they can utilize the infrastructure and facility of an already licensed manufacturer, ensuring compliance with regulatory standards while streamlining production.

If you are a medical device manufacturer looking to leverage an established production facility, obtaining an MD-6 Loan License is essential for regulatory approval, legal compliance, and seamless market entry.

A Loan License (MD-6) is granted to manufacturers who do not own a production facility but wish to manufacture medical devices using the infrastructure of an existing licensed manufacturer. This arrangement helps businesses reduce initial capital investment while maintaining compliance with CDSCO regulations.

• Medical device companies without their own manufacturing setup
• Startups looking to enter the healthcare industry with minimal infrastructure investment
• Businesses aiming to expand their product portfolio using third-party manufacturing facilities
• Companies that want to leverage the expertise and quality control of an established manufacturer

The CDSCO MD-6 Loan License applies to Class A & Class B medical devices, which are categorized based on risk levels:

Class A (Low-Risk Medical Devices).

These devices are considered low-risk and include:
✔ Thermometers
✔ Surgical dressings
✔ Stethoscopes
✔ Tongue depressors
✔ Blood pressure cuffs

Class B (Low to Moderate Risk Medical Devices)

These devices have a slightly higher risk than Class A and include:
✔ Nebulizers
✔ Syringes
✔ Surgical gloves
✔ Blood glucose monitors
✔ Catheters

For Class C & Class D (moderate to high-risk medical devices), a different licensing process applies.

The application process for an MD-6 Loan License involves several steps to ensure compliance with the regulatory framework. Below is a step-by-step guide:

1. Identify a Licensed Manufacturing Facility

Before applying for an MD-6 Loan License, the applicant must identify an existing manufacturer with a valid CDSCO license (Form MD-5 for Class A & B). The manufacturer must be willing to provide their facility for production.

2. Prepare Necessary Documentation

The following documents must be submitted along with the application:

• Application Form (MD-6)
• Device Master File (DMF) with product details
• Quality Management System (QMS) compliance certificate
• Manufacturing agreement with the licensed manufacturer
• Labeling and packaging details
• Sterilization and testing reports (if applicable)
• Declaration of conformity with CDSCO standards

3. Submit the Application to CDSCO

Once all the documents are prepared, the applicant must submit the application to the CDSCO or the concerned State Licensing Authority (SLA) based on the location of the manufacturing facility.

4. Regulatory Inspection & Approval

Regulatory authorities may conduct an inspection of the manufacturing facility to ensure compliance with Good Manufacturing Practices (GMP). Upon successful verification, the MD-6 Loan License is issued.

5. License Issuance & Manufacturing Commencement

After approval, the applicant can start manufacturing the medical devices under the loan license and legally market them in India.

To maintain the validity of the CDSCO MD-6 Loan License, the manufacturer must comply with the following regulations:

✔ Adherence to Good Manufacturing Practices (GMP)
✔ Compliance with ISO 13485:2016 for Quality Management Systems
✔ Proper labeling and packaging in accordance with CDSCO standards
✔ Regular audits and inspections by regulatory authorities
✔ Maintenance of manufacturing and distribution records

Failure to comply with these regulations may result in license suspension or cancellation.

The CDSCO MD-6 Loan License is typically valid for five years from the date of issuance. To continue manufacturing medical devices under the loan license, the applicant must apply for renewal before the expiry date. The renewal process involves:

1. Submission of updated documentation (if any modifications are made to the manufacturing process or facility)
2. Payment of renewal fees
3. Regulatory inspection (if required)

It is essential to track the expiration date and apply for renewal on time to avoid production delays.

The MD-6 Loan License offers multiple benefits for businesses in the medical device sector:

✔ Cost Savings: No need to invest in a new manufacturing facility
✔ Faster Market Entry: Quick regulatory approval process
✔ Access to Experienced Manufacturers: Utilize the expertise of licensed manufacturers
✔ Regulatory Compliance: Ensures adherence to CDSCO guidelines
✔ Scalability: Allows businesses to expand their product line without infrastructure constraints

By leveraging a loan license, businesses can focus on innovation, branding, and distribution while ensuring high-quality manufacturing.

The CDSCO MD-6 Loan License is an ideal solution for medical device manufacturers looking to produce Class A & Class B medical devices without setting up their own production units. This licensing framework not only reduces the financial burden but also ensures compliance with stringent CDSCO regulations.

If you are planning to apply for an MD-6 Loan License, make sure to follow the proper documentation and regulatory guidelines to streamline the approval process. For expert assistance in obtaining your loan license, feel free to contact us today!

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