CDSCO Loan License for Medical Devices

CDSCO Loan License for Medical Devices. The Central Drugs Standard Control Organisation (CDSCO), operating under the Ministry of Health and Family Welfare (MoHFW), plays an important role in regulating medical devices and pharmaceuticals in India. One of the significant provisions under the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017, is the concept of the CDSCO Loan License. This article explores in detail what a CDSCO Loan License is, its relevance to medical device manufacturers, the forms involved, responsible authorities, validity, and documentation.
What is a CDSCO Loan License?
A CDSCO Loan License is a regulatory provision that allows an applicant, who does not own a manufacturing facility, to use an existing licensed manufacturing unit to produce medical devices. This license is granted by the CDSCO under the Drugs and Cosmetics Act, 1940. It is particularly useful for businesses that want to enter the medical device manufacturing space without incurring the high costs of setting up their own production infrastructure. The applicant can leverage the facilities of an already licensed manufacturer to produce medical devices under their own brand name. This helps new entrants and small manufacturers to comply with regulatory norms without heavy capital investment.
Legal Framework: Medical Devices Rules, 2017
The legal foundation for CDSCO Loan Licenses lies in the Medical Devices Rules, 2017, specifically under Rule 20 and Rule 21. These rules mandate that manufacturers who lack certain facilities, such as sterilization units or full-scale production capabilities, must obtain a loan license. This is especially important for those producing Class A, B, C, or D medical devices.
The rules ensure that medical devices meet necessary safety and efficacy standards even when the manufacturer does not directly own a production facility. It maintains the integrity of the medical devices being marketed and used in the Indian healthcare ecosystem.
Importance of CDSCO Loan License for Medical Devices
The CDSCO Loan License for medical devices is essential for bridging gaps in manufacturing capability. Many startups and smaller companies in the medical device sector may have innovative products but lack the infrastructure to produce them.
With a loan license, they can contract a third-party manufacturer who already has the required CDSCO approval and infrastructure. This helps them launch products faster, enter the market competitively, and comply with regulatory standards. It also benefits companies that need to temporarily outsource manufacturing due to capacity constraints, equipment upgrades, or other strategic reasons.
Forms Required for CDSCO Loan License for Medical Devices
The forms to be used depend on the risk classification of the medical device:

Form MD-6 – This form is used for the loan license to manufacture Class A or Class B medical devices. These are considered low to moderate-risk devices. The application must be submitted to the State Licensing Authority (SLA).

Form MD-10 – This form is used for the loan license to manufacture Class C or Class D medical devices, which are considered high-risk devices. The application in this case must be submitted to the Central Licensing Authority (CLA).

Both forms require supporting documentation, payment of the prescribed fee, and detailed disclosures about the manufacturing arrangement.
Who Grants the CDSCO Loan License?
The grant of the CDSCO Loan License depends on the classification of the medical device:

For Class A and Class B medical devices, the license is issued by the State Licensing Authority (SLA). The application must be filed online via Form MD-4, and upon approval, the SLA issues Form MD-6.

For Class C and Class D medical devices, the license is issued by the Central Licensing Authority (CLA). The applicant must file Form MD-8, and the license is issued via Form MD-10 upon approval.

The authorities also conduct facility inspections before granting the loan license to ensure the manufacturing setup meets CDSCO standards.
Validity of the CDSCO Loan License
The validity of a CDSCO Loan License for medical devices is perpetual, provided the manufacturer pays the maintenance fee every five years. This means the license does not expire unless:

The licensee fails to pay the renewal or maintenance fee

The license is suspended or revoked due to non-compliance with regulatory norms

This provision allows consistent manufacturing and long-term planning for license holders, reducing the administrative burden of frequent renewals.
Documentation for CDSCO Loan License Application
The applicant must provide a comprehensive set of documents to obtain the CDSCO Loan License. Below is an elaborated list:

Cover Letter – A formal letter addressed to the licensing authority explaining the purpose of the application.

Challan or Fee Receipt – Proof of payment of the requisite government fees.

Applicable Forms (MD-6 or MD-10) – Based on the class of the medical device.

Affidavit I – Declaration of the names, addresses, and credentials of the directors, partners, or proprietors.

Partnership Deed or MoA – Legally attested documents highlighting ownership structure.

Affidavit II – Declaration with a photograph of the authorized person handling daily operations.

Residential Proof – Ration Card, Aadhaar Card, or Passport copy of the applicant.

Consent Letter from Parent Company – Declaration that the parent company is offering its facility and listing its existing CDSCO licenses.

Details of Technical Personnel – Qualification and responsibilities of the individuals involved in production.

List of Previously Issued CDSCO Loan Licenses – If any.

This documentation ensures transparency and confirms that the applicant meets the minimum requirements to carry out regulated manufacturing.
Additional Documents for Specific Applications
For formulations and bulk drug usage, further documents may be required:

For Formulations:

Complete list of formulations with packaging details

Specimen labels for all products

Label templates for non-pharmacopeial products

Test methods for non-standard ingredients

Monograph copy for drugs not listed in the Indian Pharmacopeia

For Bulk Drug Use:

Detailed production process and flowchart

Consumption coefficients

Waste treatment process details

These documents provide clarity on the manufacturing process and ensure that all aspects of product quality are considered.
Inspection and Approval Timeline
Once the loan license application is submitted:

For Class A and B devices, SLA processes the application typically within a few weeks.

For Class C and D devices, the CLA must complete a site inspection within 60 days.

Only after a successful inspection will the approval be granted. The authorities ensure that all statutory and safety parameters are met before issuance.
Why Do Manufacturers Opt for CDSCO Loan License?
Manufacturers opt for the CDSCO Loan License pathway for several reasons:

It significantly reduces capital investment, making market entry affordable.

It supports innovation by helping startups and SMEs with limited resources.

It enables scaling production without infrastructure expansion.

It provides regulatory compliance without the complexity of full facility licensing.

This makes it an attractive choice for both domestic and foreign medical device companies looking to operate in India.
Conclusion
The CDSCO Loan License for medical devices is a well-structured regulatory tool that promotes innovation and participation in India's growing healthcare market. It provides a flexible manufacturing arrangement for companies without their own production infrastructure, helping them bring quality products to market efficiently.
By following the proper procedures, submitting the right documents, and collaborating with licensed manufacturers, businesses can ensure full compliance with Indian medical device regulations. The CDSCO Loan License thus plays an important role in the safe and regulated development of the medical device sector in India.
If you need any support in getting CDSCO Loan License, then you can book a consultation with our experts through email at info@ccoffice.in or Call/Whatsapp at +91 9988424211.
FAQs
Q1. What is a CDSCO Loan License and who can apply for it?
Ans. A CDSCO Loan License is a regulatory license granted to applicants who do not own a manufacturing facility but intend to produce medical devices using an already licensed manufacturing unit. It is ideal for startups, SMEs, and firms without in-house production capabilities but looking to legally manufacture and distribute medical devices under their brand name.
Q2. What are the forms required to apply for a CDSCO Loan License for medical devices?
Ans. To apply, manufacturers must submit Form MD-6 for Class A and B medical devices and Form MD-10 for Class C and D devices. These forms correspond to the device's risk classification and must be accompanied by supporting documentation and the prescribed fee.
Q3. Who are the regulatory authorities responsible for issuing the CDSCO Loan License?
Ans. The State Licensing Authority (SLA) handles Class A and B devices, while the Central Licensing Authority (CLA) oversees Class C and D devices. Each authority conducts a facility inspection before granting approval, ensuring compliance with quality and safety norms.
Q4. What is the validity period of a CDSCO Loan License?
Ans. The CDSCO Loan License remains valid indefinitely, provided the licensee pays a maintenance fee every five years. If the fee is not paid or the licensee violates any regulatory conditions, the license may be suspended or revoked.
Q5. What are the key documents required to obtain a CDSCO Loan License?
Ans. Applicants must submit a cover letter, payment challan, appropriate forms (MD-6 or MD-10), affidavits, ID proofs, consent letters from the parent company, and details of technical personnel. Additional documents may be needed depending on whether the application is for formulations or bulk drugs.
Q7. Why do manufacturers prefer the loan license route under CDSCO?
Ans. The loan license route helps reduce upfront investment in infrastructure. It allows quick market entry, ensures regulatory compliance without owning a production facility, and is especially beneficial for small businesses and foreign manufacturers entering India.
Q8. How long does it take to get a CDSCO Loan License approved?
Ans. Approval timelines vary by device class. For Class A and B devices, the SLA may take a few weeks to process the application. For Class C and D devices, the CLA is required to inspect the facility within 60 days of receiving the application, post which approval is granted.
Q9. Can a company hold multiple CDSCO Loan Licenses simultaneously?
Ans. Yes, a company can hold multiple CDSCO Loan Licenses as long as each license is applied for specific products or formulations, and the manufacturing facility meets the necessary regulatory requirements for each application.

The Central Drugs Standard Control Organisation (CDSCO), operating under the Ministry of Health and Family Welfare (MoHFW), plays an important role in regulating medical devices and pharmaceuticals in India. One of the significant provisions under the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017, is the concept of the CDSCO Loan License. This article explores in detail what a CDSCO Loan License is, its relevance to medical device manufacturers, the forms involved, responsible authorities, validity, and documentation.

What is a CDSCO Loan License?

A CDSCO Loan License is a regulatory provision that allows an applicant, who does not own a manufacturing facility, to use an existing licensed manufacturing unit to produce medical devices. This license is granted by the CDSCO under the Drugs and Cosmetics Act, 1940. It is particularly useful for businesses that want to enter the medical device manufacturing space without incurring the high costs of setting up their own production infrastructure. The applicant can leverage the facilities of an already licensed manufacturer to produce medical devices under their own brand name. This helps new entrants and small manufacturers to comply with regulatory norms without heavy capital investment.

Legal Framework: Medical Devices Rules, 2017

The legal foundation for CDSCO Loan Licenses lies in the Medical Devices Rules, 2017, specifically under Rule 20 and Rule 21. These rules mandate that manufacturers who lack certain facilities, such as sterilization units or full-scale production capabilities, must obtain a loan license. This is especially important for those producing Class A, B, C, or D medical devices.

The rules ensure that medical devices meet necessary safety and efficacy standards even when the manufacturer does not directly own a production facility. It maintains the integrity of the medical devices being marketed and used in the Indian healthcare ecosystem.

Importance of CDSCO Loan License for Medical Devices

The CDSCO Loan License for medical devices is essential for bridging gaps in manufacturing capability. Many startups and smaller companies in the medical device sector may have innovative products but lack the infrastructure to produce them.

With a loan license, they can contract a third-party manufacturer who already has the required CDSCO approval and infrastructure. This helps them launch products faster, enter the market competitively, and comply with regulatory standards. It also benefits companies that need to temporarily outsource manufacturing due to capacity constraints, equipment upgrades, or other strategic reasons.

Forms Required for CDSCO Loan License for Medical Devices

The forms to be used depend on the risk classification of the medical device:

Form MD-6 – This form is used for the loan license to manufacture Class A or Class B medical devices. These are considered low to moderate-risk devices. The application must be submitted to the State Licensing Authority (SLA).
Form MD-10 – This form is used for the loan license to manufacture Class C or Class D medical devices, which are considered high-risk devices. The application in this case must be submitted to the Central Licensing Authority (CLA).

Both forms require supporting documentation, payment of the prescribed fee, and detailed disclosures about the manufacturing arrangement.

Who Grants the CDSCO Loan License?

The grant of the CDSCO Loan License depends on the classification of the medical device:

For Class A and Class B medical devices, the license is issued by the State Licensing Authority (SLA). The application must be filed online via Form MD-4, and upon approval, the SLA issues Form MD-6.
For Class C and Class D medical devices, the license is issued by the Central Licensing Authority (CLA). The applicant must file Form MD-8, and the license is issued via Form MD-10 upon approval.

The authorities also conduct facility inspections before granting the loan license to ensure the manufacturing setup meets CDSCO standards.

Validity of the CDSCO Loan License

The validity of a CDSCO Loan License for medical devices is perpetual, provided the manufacturer pays the maintenance fee every five years. This means the license does not expire unless:

The licensee fails to pay the renewal or maintenance fee
The license is suspended or revoked due to non-compliance with regulatory norms

This provision allows consistent manufacturing and long-term planning for license holders, reducing the administrative burden of frequent renewals.

Documentation for CDSCO Loan License Application

The applicant must provide a comprehensive set of documents to obtain the CDSCO Loan License. Below is an elaborated list:

Cover Letter – A formal letter addressed to the licensing authority explaining the purpose of the application.
Challan or Fee Receipt – Proof of payment of the requisite government fees.
Applicable Forms (MD-6 or MD-10) – Based on the class of the medical device.
Affidavit I – Declaration of the names, addresses, and credentials of the directors, partners, or proprietors.
Partnership Deed or MoA – Legally attested documents highlighting ownership structure.
Affidavit II – Declaration with a photograph of the authorized person handling daily operations.
Residential Proof – Ration Card, Aadhaar Card, or Passport copy of the applicant.
Consent Letter from Parent Company – Declaration that the parent company is offering its facility and listing its existing CDSCO licenses.
Details of Technical Personnel – Qualification and responsibilities of the individuals involved in production.
List of Previously Issued CDSCO Loan Licenses – If any.

This documentation ensures transparency and confirms that the applicant meets the minimum requirements to carry out regulated manufacturing.

Additional Documents for Specific Applications

For formulations and bulk drug usage, further documents may be required:

For Formulations:

Complete list of formulations with packaging details
Specimen labels for all products
Label templates for non-pharmacopeial products
Test methods for non-standard ingredients
Monograph copy for drugs not listed in the Indian Pharmacopeia

For Bulk Drug Use:

Detailed production process and flowchart
Consumption coefficients
Waste treatment process details

These documents provide clarity on the manufacturing process and ensure that all aspects of product quality are considered.

Inspection and Approval Timeline

Once the loan license application is submitted:

For Class A and B devices, SLA processes the application typically within a few weeks.
For Class C and D devices, the CLA must complete a site inspection within 60 days.

Only after a successful inspection will the approval be granted. The authorities ensure that all statutory and safety parameters are met before issuance.

Why Do Manufacturers Opt for CDSCO Loan License?

Manufacturers opt for the CDSCO Loan License pathway for several reasons:

It significantly reduces capital investment, making market entry affordable.
It supports innovation by helping startups and SMEs with limited resources.
It enables scaling production without infrastructure expansion.
It provides regulatory compliance without the complexity of full facility licensing.

This makes it an attractive choice for both domestic and foreign medical device companies looking to operate in India.

Conclusion

The CDSCO Loan License for medical devices is a well-structured regulatory tool that promotes innovation and participation in India's growing healthcare market. It provides a flexible manufacturing arrangement for companies without their own production infrastructure, helping them bring quality products to market efficiently.

By following the proper procedures, submitting the right documents, and collaborating with licensed manufacturers, businesses can ensure full compliance with Indian medical device regulations. The CDSCO Loan License thus plays an important role in the safe and regulated development of the medical device sector in India.

If you need any support in getting CDSCO Loan License, then you can book a consultation with our experts through email at info@ccoffice.in or Call/Whatsapp at +91 9988424211.

FAQs

Q1. What is a CDSCO Loan License and who can apply for it?

Ans. A CDSCO Loan License is a regulatory license granted to applicants who do not own a manufacturing facility but intend to produce medical devices using an already licensed manufacturing unit. It is ideal for startups, SMEs, and firms without in-house production capabilities but looking to legally manufacture and distribute medical devices under their brand name.

Q2. What are the forms required to apply for a CDSCO Loan License for medical devices?

Ans. To apply, manufacturers must submit Form MD-6 for Class A and B medical devices and Form MD-10 for Class C and D devices. These forms correspond to the device's risk classification and must be accompanied by supporting documentation and the prescribed fee.

Q3. Who are the regulatory authorities responsible for issuing the CDSCO Loan License?

Ans. The State Licensing Authority (SLA) handles Class A and B devices, while the Central Licensing Authority (CLA) oversees Class C and D devices. Each authority conducts a facility inspection before granting approval, ensuring compliance with quality and safety norms.

Q4. What is the validity period of a CDSCO Loan License?

Ans. The CDSCO Loan License remains valid indefinitely, provided the licensee pays a maintenance fee every five years. If the fee is not paid or the licensee violates any regulatory conditions, the license may be suspended or revoked.

Q5. What are the key documents required to obtain a CDSCO Loan License?

Ans. Applicants must submit a cover letter, payment challan, appropriate forms (MD-6 or MD-10), affidavits, ID proofs, consent letters from the parent company, and details of technical personnel. Additional documents may be needed depending on whether the application is for formulations or bulk drugs.

Q7. Why do manufacturers prefer the loan license route under CDSCO?

Ans. The loan license route helps reduce upfront investment in infrastructure. It allows quick market entry, ensures regulatory compliance without owning a production facility, and is especially beneficial for small businesses and foreign manufacturers entering India.

Q8. How long does it take to get a CDSCO Loan License approved?

Ans. Approval timelines vary by device class. For Class A and B devices, the SLA may take a few weeks to process the application. For Class C and D devices, the CLA is required to inspect the facility within 60 days of receiving the application, post which approval is granted.

Q9. Can a company hold multiple CDSCO Loan Licenses simultaneously?

Ans. Yes, a company can hold multiple CDSCO Loan Licenses as long as each license is applied for specific products or formulations, and the manufacturing facility meets the necessary regulatory requirements for each application.