Import License

The Medical Device/IVD Import License, regulated by the Central Drugs Standard Control Organization (CDSCO), is a crucial authorization required for the importation of medical devices and in vitro diagnostics (IVDs) into India. This licence ensures that imported medical devices and IVDs meet the stringent quality, safety, and performance standards established by the Indian regulatory framework, safeguarding public health and maintaining the integrity of the medical device market.

The import of medical devices and IVDs into India is governed by the Medical Device Rules, 2017. These regulations are designed to control the quality of medical devices entering the Indian market, ensuring they are safe for use and effective in their intended purposes. An import licence is mandatory for any entity seeking to import medical devices or IVDs, and it applies to all classes of devices, from low-risk (Class A) to high-risk (Class D) categories.

Licensing Process

The process for obtaining a Medical Device/IVD Import License involves:

Application Submission: The applicant must submit Form MD-14 to the CDSCO, accompanied by the required documents. These documents include detailed product information, a Free Sale Certificate (FSC) from the country of origin, a copy of the quality management system certification (such as ISO 13485), and evidence of compliance with the essential principles of safety and performance.

Authorised Indian Agent: Foreign manufacturers must appoint an authorised Indian agent who will be responsible for the importation and compliance with regulatory requirements. The agent must have a wholesale licence for the sale or distribution of medical devices and act as the point of contact for the CDSCO.

Review and Evaluation: The CDSCO conducts a thorough review of the application and accompanying documents. This review includes an assessment of the product’s safety, efficacy, and quality, as well as the manufacturing process and facilities of the foreign manufacturer.

Inspection: In some cases, the CDSCO may conduct an inspection of the manufacturing site to verify compliance with Good Manufacturing Practices (GMP) and other regulatory standards. This inspection ensures that the manufacturing processes are robust and capable of consistently producing high-quality medical devices and IVDs.

Granting of Licence: If the application and inspection (if conducted) are satisfactory, the CDSCO grants the import licence in Form MD-15. This licence authorises the importation of the specified medical devices or IVDs into India.

MD-14:

Form MD-14 under the Central Drugs Standard Control Organization (CDSCO) is a document required for the import of medical devices and in vitro diagnostics (IVDs) into India. It is the application for the issue of import licence to import medical devices. The primary purpose of Form MD-14 is to provide the CDSCO with comprehensive information about the medical devices or IVDs that an applicant intends to import. This ensures that the regulatory authorities can assess the safety, efficacy, and quality of these products, protecting public health and maintaining the integrity of the healthcare system.

Application Process:

Submission of Form MD-14: The applicant, typically an authorised Indian agent representing a foreign manufacturer, submits Form MD-14 to the CDSCO. The form must be completed accurately and thoroughly, as any discrepancies or omissions can lead to delays or rejection of the application.

Required Documentation: Along with Form MD-14, several supporting documents must be provided:

Free Sale Certificate (FSC): A certificate from the country of origin stating that the device is freely sold and marketed in that country.

Quality Management System (QMS) Certification: Evidence of compliance with international standards, such as ISO 13485.

Product Information: Detailed descriptions, including technical specifications, labelling information, and intended use of the device.

Clinical Data: Relevant clinical trial data or performance evaluations demonstrating the safety and efficacy of the device.

Manufacturing Information: Details about the manufacturing process and facilities, ensuring they comply with Good Manufacturing Practices (GMP).

Appointment of Authorised Indian Agent: Foreign manufacturers must appoint an authorised Indian agent who holds a wholesale licence for the distribution of medical devices. This agent is responsible for the importation process and ensures compliance with all regulatory requirements.

Once Form MD-14 and the supporting documents are submitted, the CDSCO undertakes a thorough review process.

MD-15:

Form MD-15 under the Central Drugs Standard Control Organization (CDSCO) is a critical document within the Indian regulatory framework for medical devices and in vitro diagnostics (IVDs). This form is issued to grant the import licence for medical devices and IVDs, ensuring that these products meet the necessary safety, efficacy, and quality standards before entering the Indian market.

Form MD-15 serves as the official authorization for entities to import specified medical devices and IVDs into India. The issuance of this form signifies that the imported products have been thoroughly reviewed and found compliant with the Medical Device Rules, 2017.

To obtain Form MD-15, the applicant must first submit a comprehensive application in Form MD-14 to the CDSCO. This application includes essential documents such as the Free Sale Certificate (FSC) from the country of origin, quality management system certifications (e.g., ISO 13485), product specifications, and evidence of compliance with safety and performance standards. The applicant must also designate an authorised Indian agent responsible for regulatory compliance and communication with the CDSCO.

Upon receiving the application, the CDSCO conducts a meticulous evaluation of the submitted documents. This includes verifying the product’s safety, efficacy, and quality, as well as assessing the manufacturing processes and facilities of the foreign manufacturer. The CDSCO may also conduct on-site inspections of the manufacturing facilities to ensure adherence to Good Manufacturing Practices (GMP) and other regulatory requirements.

If the application meets all regulatory criteria and the inspection results are satisfactory, the CDSCO grants the import licence by issuing Form MD-15. This form authorises the importation of the specified medical devices and IVDs into India. It includes details such as the name and address of the importer, the name and address of the foreign manufacturer, the product details, and the conditions under which the import licence is granted.

Benefits:

The Medical Device/IVD Import License system provides several benefits. It ensures that only high-quality, safe, and effective medical devices and IVDs are imported into India, protecting public health and enhancing patient safety. By enforcing rigorous regulatory standards, it also helps prevent the entry of substandard or counterfeit products into the market. Moreover, the import licensing system fosters international trade in medical devices by providing a clear and transparent regulatory pathway for foreign manufacturers. It enables Indian healthcare providers and patients to access a wide range of advanced medical technologies and innovations, contributing to the overall improvement of healthcare services in the country.