The Medical Devices Act of 2017, provides a regulatory framework governing medical devices marketed in India. The regulations ensure safe, effective, and high-quality medical devices enter the market. This ensures medical devices meeting certain quality benchmark are available to the Indian healthcare sector, thus protecting the public health. Central Drugs Standard Control Organization (CDSCO) grants loan license for medical devices to help medical device manufacturers not having a manufacturing facility or infrastructure.  The medical device loan license applicant must meet the regulatory criteria set by CDSCO.

A medical device manufacturing company can request to loan another medical device manufacturer’s manufacturing site. In order to apply for a loan license, the licensee must select a manufacturer with a valid manufacturing license. In this blog, we will delve into loan license for medical devices.

What is the CDSCO loan license for medical devices?

CDSCO loan license is granted to a medical device manufacturer, lacking a production facility, who wants to utilize the manufacturing facility/site of another manufacturer. It is granted only if the “other manufacturer” also manufactures the same medical device at the facility as the loan licensee. There should be a mutual agreement between two parties for utilizing the manufacturing infrastructure to produce the same medical device.

Who can opt for loan license for medical devices?

• Manufacturers lacking funds to set up a medical device manufacturing facility
• Manufacturers with a valid manufacturing license but do not having the necessary sterilization facilities
• Medical device startups
• Foreign companies
• Indian companies

Benefits of the scheme

The loan license for medical devices can help support and boost the medical device manufacturing business. This scheme will support medical device manufacturers by helping them save funds that would have been spent on manufacturing facilities.

• Manufacturers not having manufacturing facilities/infrastructure can benefit from loan license for medical devices.
• Small firms not having sufficient funds to invest on manufacturing units can enter the medical device manufacturing industry.
• Instead of constructing, managing, and maintaining, a manufacturing unit, the medical device manufacturer can focus on market expansion.
• The manufacturer can allocate the funds intended for medical device manufacturing facilities or equipment to research and innovation.

Criteria for applying for a loan license for medical devices

• The medical device manufacturing team must have qualified technical personnel with expertise in medical device testing. The personnel will oversee and supervise the medical device manufacturing and testing process.
• The manufacturing facility must comply with the quality management system guidelines.

CDSCO loan license details

• The licensor will provide the licensee with the necessary manufacturing facilities and infrastructure for manufacturing the medical device. The licensor will share the technical know-how for the manufacturing process.
• The licensee will be responsible for compliance with necessary quality and safety standards for the medical device manufactured. 
• The licensee must obtain regulatory approvals from the CDSCO to manufacture and market their medical device in India.
• The licensee must pay a fee for using the licensor’s medical device manufacturing facilities and infrastructure.

Necessary documents

The following are some of the documents that are needed to apply for a loan license for medical devices:

• Cover letter
• All applicable forms
• TR6 challan
• Site Master File
• Device Master File
• Quality Management System Documents
• Manufacturing License
• Declaration of qualified technical personnel involved in the medical device manufacturing and testing process

License application process and licensing authorities for the different medical device classes

CDSCO has divided the medical devices into various classes depending on their intended used and risk level. The medical device classes are class A, B, C, and D. This medical device classification system helps with the CDSCO registration process. The license application process and licensing authorities vary depending on the medical device class system. It is important to know which form to use while applying for a CDSCO loan license. The following is an overview of the license application process, necessary forms, and licensing authorities:

Class A and B medical devices

Manufactures seeking to obtain a loan license for Class A and B medical devices need to apply to the State Licensing Authority (SLA). The medical device manufacturer has to apply online using the Form MD-4 and pay the necessary processing fee. The regulatory body will relay the approval via Form MD-6. This will permit the manufacturer to manufacture, sell, and distribute Class A or Class B medical devices.

Class C and D medical devices

Manufactures seeking to obtain a loan license for Class C and D medical devices need to apply to the Central Licensing Authority (CLA). The medical device manufacturer has to apply online using the Form MD-8 and pay the necessary processing fee. Medical device regulatory officers will inspect the production facility within sixty days from the date of application. The regulatory body will relay the approval via Form MD-10. This will permit the manufacturer to manufacture, sell, and distribute Class C or Class D medical devices.

CDSCO medical device loan license application process

The following outlines the application process:

1. Login/signup: The first step is to login/signup on the online registration portal, SUGAM, on the CDSCO website.
2. Application: An application needs to be prepared based on the license application process requirements.
3. Submission: Necessary supporting documents along with the application using the pertinent form need to be submitted to the online registration portal.
4. Grant of CDSCO loan license: The regulatory body officials will review the application and verify the documents. An inspection of the facility will be carried, if necessary. Then, if the regulatory criteria are satisfied, the license will be granted by the authority.

License validity

The medical device loan license for all classes (A, B, C, and D) remains valid for an indefinite period. However, a license retention fee (amount depending on the medical device class) needs to be paid every 5 years. Additionally, the license will remain valid indefinitely only if not cancelled by the concerned regulatory body.

The loan license for medical devices allows manufacturers not owning a manufacturing facility to manufacture medical devices. The CDSCO medical device loan license has certain regulatory requirements. The requirements ensure that although the manufacturing process is being outsourced, the license holder will be responsible for maintaining the quality and safely of the medical device. The license application process is tedious and complicated.

How can Pharmadocx Consultants help you obtain a loan license for medical devices?

We leverage our expertise and industry knowledge to help medical device manufacturers navigate the complex CDSCO registration process. Our expertise will help you avoid the common pitfalls encountered while obtaining a license.

Documentation: We will help you prepare the necessary documents as per regulatory body guidelines.

License application: We will support you during the complex license application process. We will provide guidance and help you fill in the correct application form.

Mock audit: Our mock audit service will prepare you for the inspection and audit carried out by the regulatory officials.

License grant support: We not only provide license application support but also assist in procuring the license. Our team of experts will help you respond to any query raised by the officials. We will monitor the application process till the license is granted.

Our aim is to make the application process for loan license for medical devices easy so that you can focus on establishing your business. Call/Whatsapp us at 9996859227 or drop an email at [email protected].