Types of Medical Device Approval Licenses Issued by CDSCO in India

The healthcare sector holds a crucial position in safeguarding the nation's health, with an importance given to the safety, quality and effectiveness of medical devices. In India, the Central Drugs Standard Control Organization (CDSCO) functions as the regulatory body. CDSCO is entrusted with the responsibility of guaranteeing that medical devices introduced into the market adhere to all the essential quality and safety criteria. In other words, CDSCO oversees medical device registration in India.

To accomplish this objective, CDSCO issues a range of medical devices licenses for its approval. Registration of medical devices does not mean that it has been authorized for marketing. It is mandatory to obtain a medical device license unless it is exempted from licensing. This blog will delve into these medical device licenses and provide insights into the regulatory structure governing medical devices in India.

CDSCO Medical Device Classification

Before going into the medical device license details, let’s take a look at the CDSCO Medical Device Classification of India. As medical devices are of various types the risk for each type of device also varies. Class A medical devices have the lowest risk and Class D medical devices have the highest risk potential. The risk classification is depicted below:

Now let's get into the types of medical device licenses granted by CDSCO in India.

Import License

CDSCO issues import licenses for the importation of medical devices to India that are manufactured in foreign production facilities. An authorized agent, holding a license for manufacturing, distribution, or wholesale distribution, is required to submit an application for the issuance of an import license to the Central Licensing Authority through the online SUGAM portal.

The Central Licensing Authority (CLA) will provide a review response within a period of nine months from the application date. The licensee must also include the overseas manufacturer who has granted power of attorney in favor of the authorized agent.

Once granted, a license remains valid indefinitely, unless it is canceled or voluntarily surrendered. However, the authorized agent must deposit the license retention fee with the Central Licensing Authority for each overseas manufacturing site and for each licensed medical device every five years from the date of issuance.

Manufacturing License

To produce medical devices in India, it is imperative to obtain a Manufacturing License for medical devices in India, from CDSCO for medical device registration in India. This license is provided to facilities that satisfy rigorous quality criteria and possess the essential infrastructure and technical competence for the safe and efficient production of medical devices. Manufacturers are obligated to adhere to the Good Manufacturing Practices (GMP) set forth by CDSCO.

Loan License

A loan license for registration of medical devices in India enables the licensee to utilize an existing license holder's manufacturing facility to produce specific medical devices. This license is granted when the licensee lacks their own manufacturing facility or sterilization capabilities. To secure a loan license, the licensee must choose a manufacturer who already possesses a manufacturing license.

Loan licenses for various classes of medical devices are issued by the appropriate licensing authority, either the State Licensing Authority (SLA) for Class A and Class B devices or the Central Licensing Authority (CLA) for Class C and Class D devices. The process entails the submission of the relevant application forms, and upon approval, the licensee can utilize the designated facility to manufacture the specified medical devices.

The fee for loan license is shown in the table below:

Sales License

Entities wishing to market medical devices in India must acquire a Sales License. This license guarantees that medical devices are distributed through authorized channels and that distributors and retailers adhere to legal requirements. It additionally safeguards the safe delivery of devices to end-users and preserves their quality as they traverse the distribution network.

As per the notification from the Ministry of Health and Family Welfare it is stated that any person who intends to sell a medical device but is not holding a license according to the Medical Device Rules, 2017, Rule 87, sub-rule (1) must obtain a registration certificate. The Registration certificate to sell, exhibit, stock or offer for the distribute or sale of a medical device including in vitro diagnostic medical device.

Test License for manufacturing

CDSCO issues a Test license, allowing the manufacturing of a limited quantity of Class A, Class B, Class C, or Class D medical devices for purposes such as clinical investigations, testing, evaluation, examination, demonstration, or training. To obtain this license, applicants must submit an application using Form MD-12 to the Central Licensing Authority and include the required fee.

Upon satisfying the necessary criteria, the Central Licensing Authority will grant a test license in Form MD-13 within thirty days from the date of application. This license remains valid for a duration of three years from its date of issuance unless it is revoked. The licensee is obligated to maintain a record detailing the quantity of products manufactured under the test license.

Test License for Importation

The CDSCO grants a Test license for the import of medical devices, including In-Vitro Diagnostic medical devices, in Form MD-17 for the purposes of testing, evaluation, clinical investigations, demonstration, or training.

The applicant must submit an application form to the CLA to get an import license for the testing, evaluation, training or demonstration. The application is made in Form MD-16. A fee of $100 should also be paid along with this application. Following this, the CLA will assess the quantity of medical devices to be imported. The CLA also takes into consideration the factors like the requirements of clinical trial, approved plan of the clinical investigation, the information and other documents provided by the applicant.

Free Sale Certificate

A Free Sale Certificate, issued by CDSCO, serves as confirmation of the quality and safety of medical devices produced in India and earmarked for overseas export. This certificate acts as evidence that these devices comply with the regulatory standards of the destination country.

For Class A and Class B medical devices that hold a valid manufacturing license for sale and distribution of medical devices, the application for FSC is made to and issued by the Central Licensing Authority. When coming to Class C and Class D medical devices, it is the State Licensing Authority. Noted that the medical devices holding manufacturing license for the sale or distribution of medical devices must be valid under the Medical Devices Rules, 2017. The fee for FSC is Rs 1000 per category of medical device.

Conclusion

Navigating through the CDSCO regulatory requirements for medical devices can be complex. Because of the diversity in the medical devices and their increasing level of risk as classes move up, stringent regulatory standards are set forth. This is done to make sure the availability of safe and effective medical devices to the Indian population. Complaining with these stringent regulations is a must for being a holder of a medical devices licence in India.

As everything is under evolution, so are the regulatory requirements. The manufacturers, importers, distributors and other stakeholders should stay updated with the current rules and regulations. This is important because it allows for a streamlined regulatory process, improved patient care quality and safety.

This can be confusing especially for those who are new to Indian medical device regulations. Artixio can help you in leading you through these complexities. Our 20+ years of experience in the regulatory sector and our regional experts with 15-30 years of experience in the medical device industry can guide you through CDSCO regulatory standards. Connect with us for guidance and extensive support through info@artixio.com

FAQ’s

Q. Who is the Central Licensing Authority in India for medical devices?

The Drug Controller General of India is the Central Licensing Authority for medical devices in India.

Q. Do I need any license to conduct clinical investigations in India for medical devices?

No, a license is not required to conduct clinical investigations but you have to take permission from the authority. Permission to conduct a pilot or pivotal clinical investigation of medical devices must be applied in appropriate form. Only after the grant of permission, the clinical investigations can be performed.

Q. Are any medical devices exempted from licensing under CDSCO?

Non-sterile, non-measuring devices that belong to Class A medical devices are exempted from licensing approval. Since they are medical devices with the lowest risk, they do not need any licensing, but registration and self-certification is mandatory. They must comply with the essential performance checklist designed for safety and performance of such devices.

Q. What should I do if I have an issue with my regulatory processes for medical devices in India?

CDSCO provides consultation services regardless of whether you are an importer, manufacturer, innovator or have a startup. The Public Relations Office (PRO) cell established under the CDSCO headquarters can address the issue relating to the medical device's regulatory pathway.