‘Importer’ means any natural or legal person established within the Indian territory that places a device from a third country in the Indian Market. The Indian medical device sector does not manufacture sufficient quantity of device as per the market demand. India mainly depends on importing medical devices to suffice with the healthcare demands.
The Government of India has ensured that the medical device sector gets considered as significant as other sectors and has recently developed medical device rules, commonly known as Indian Medical Device Rules, 2017. This requires an authorised agent, who can apply for the grant of import license to the Central Licensing Authority (CLA)
Who Needs a Medical Device Import License?
Anyone looking to import medical devices into India needs to obtain a CDSCO medical device import license. This license ensures that the medical devices comply with India’s regulatory standards, providing safety and quality assurance for healthcare products. Manufacturers or authorized agents must apply for the medical device import license through the CDSCO to legally import devices. The medical import license helps streamline the import process, ensuring compliance with Indian Medical Device Rules, 2017.
Types of Medical Device Import Licenses
Types of Medical Device Import Licenses include various categories depending on the device’s risk classification. The CDSCO medical device import license is crucial for ensuring the safety and efficacy of imported devices. An import license for medical devices is issued based on compliance with the Indian Medical Device Rules 2017, covering everything from low-risk to high-risk devices. Ensuring the appropriate medical device import license is obtained helps maintain regulatory standards and safeguard public health.
Indian Authorised Agent for Medical Devices
An Indian Authorised Agent is a person, firm, or organization based in India that is appointed by an overseas manufacturer through a power of attorney to manage the import of medical devices into the country. The authorised agent serves as a liaison between the Central Drugs Standard Control Organization (CDSCO) and the overseas manufacturer, ensuring all regulatory requirements are met. They play a crucial role in obtaining the CDSCO medical device import license and facilitating the process for obtaining the medical device import license. The authorised agent ensures that the import license for medical devices is properly obtained, enabling the smooth importation of medical devices into India.
Responsibilities of an Authorised Agent for CDSCO Compliance
- Import of Medical Devices in India
An authorised agent holding a licence to manufacture for sale or distribution under Indian Medical Device Rules 2017 is required to apply for an import license for medical devices to the CDSCO through the online portal. The import license CDSCO ensures that the medical devices being imported meet the required safety and quality standards in India, in accordance with the regulations.
If the authorised agent has reasons to believe that a medical device, which has been imported, sold, or distributed, may pose a risk to the health of a user or patient and is likely to be unsafe, they must immediately initiate procedures to withdraw the medical device from the market. The agent must indicate the reasons for the withdrawal and inform the competent authority of the details. Additionally, the authorised agent must inform the competent authority immediately if there are any concerns regarding the safety of the medical device.
In cases where the FDA medical import license is required, the authorised agent must cooperate fully with the authorities to ensure the safety of the device. If there is any doubt about the device’s safety, the authorised agent must take the necessary steps to protect the patients and inform the relevant authorities, including details about the situation.
The authorised agent must follow all necessary procedures in maintaining the integrity of the import license CDSCO and ensure compliance with FDA medical import license regulations, thereby safeguarding public health.
Required Documentation for Medical Device Import License
1. Plant Master File for Medical Device Import License
A Plant Master File shall be prepared as per the requirements of Part III, Appendix I. The plant master file contains information on production and/or control of device manufacturing carried out at the premises.
2. Device Master File for Import License Applications
A Device Master File shall be prepared as per the requirements of Part III, Appendix I. The Device Master File shall be prepared for each device or device category and includes the following:
- Device description,
- Design and Manufacturing Process,
- Design verification & validation reports,
- Essential Principles checklist,
- Risk analysis report,
- Clinical evaluation,
- Biocompatibility reports,
- Stability data,
- Sterilization validation reports and
- PMS data
MD Forms Required for Medical Device Import License
- Form MD-14: Application for issue of import license to import medical device
- Form MD-15: License to Import Medical Device
The license granted under form MD-15 shall remain valid until it is cancelled or suspended by the licensing authority. The authorized agent is responsible for depositing the license renewal fees and maintain its validity.
Why Choose Maven for Your Medical Device Import License Needs?
Maven Profcon Services LLP offers expert assistance in securing your medical device import license, ensuring smooth navigation through the Indian Medical Device Rules, 2017. Our experienced team provides comprehensive support in obtaining CE Mark certification, managing regulatory compliance, and ensuring timely import license approvals. Whether you’re a first-time importer or expanding your medical device portfolio, we offer reliable and efficient services tailored to your needs. Trust Maven to help you meet all regulatory requirements and expedite your market entry.
