Import License for Medical Devices from CDSCO

In India, if a medical device is to be imported, the importer must obtain an import license from the Central Drugs Standard Organisation (CDSCO) which is the regulatory body that is responsible for the registration and regulation of medical devices in India.

Steps for Applying for an Import License from CDSCO

• Step 1- Classification of the Medical device as per their risk class (Class A, B, C, D)
• Step 2- Registration on the Sugam Portal of CDSCO
• Step 3- Uploading all the necessary documents in the Sugam Portal
• Step 4- Submission of the Government Fee
• Step 5- Submission of the Application
• Step 6- Queries could be raised by CDSCO on the Submitted Application
• Step 7- Replying to the Queries raised by the Central Drugs Standard Organisation (CDSCO)
• Step 8- Approval or Rejection of the Application
• Step 9- Grant of License

Documents Required for an Import License

• Quality Certification (CE Certification, USFDA, Health Canada etc)

For any medical device which is imported in India it must have any one of the globally accepted quality certifications to ensure that the imported devices don’t possess a threat to the safety and health of the population.

• Declaration of Conformity in the prescribed formats.
• Power of Attorney
• Device Master File
• Plant Master File
• Free Sales Certificate
• Legal Form
• Cover Letter

Who can apply for an Import License

For importing a medical device in India the foreign manufacturer has to appoint a local authorized agent who must possess a license for either manufacturing medical devices for distribution and sales (Form 20B) or wholesale distribution of medical devices (Form 21B). The applicant will then submit an application on the Sugam portal of CDSCO.

How will Maven assist you in Obtaining the Import License

We at Maven, understand the complexities of medical device regulations. Let us handle the application process of Import License and you can focus on your core business areas. Our team of experts ensure meticulous attention to detail which results in error-free applications, avoiding rejections and delays for obtaining the license.

Our scope includes:

• Explain & share the documentation requirement for an import license.
• Review the submitted documents of foreign manufacturers.
• Preparation of administrative and other documents required to be submitted to CDSCO.
• Application and uploading the documents to the Central Drugs Standard Organisation (CDSCO) portal for Import License.
• Reply to the comments if any are received from the authority.
• You will get your license after the successful closure of comments.

Government Fee to be Paid to CDSCO

The government fee to be paid is determined by the Class of Medical device based on the risk category. The fee to be paid are:

Overview of CDSCO Import License for Medical Devices

The Central Drugs Standard Control Organization (CDSCO) oversees the import of medical devices into India through an Import License system. As per Medical Device Rules, 2017, an Import License (Form MD-14/MD-15) is mandatory for devices classified under risk-based categories. Applicants must register on the SUGAM portal and submit required documents, including a Free Sale Certificate, device master file, and ISO/CE certificates. The license ensures product safety, quality, and compliance with Indian regulations. CDSCO reviews technical and regulatory information before granting approval. This process is essential for legal market access and maintaining standards for medical devices imported into India.

CDSCO Import License Registration Phases

• Classification of Device – Determine device classification (Class A, B, C, or D) as per risk level.
• SUGAM Portal Registration – Create an account on CDSCO’s SUGAM portal.
• Document Preparation – Compile required documents: Power of Attorney, Free Sale Certificate, Device Master File, ISO/CE certificates, etc.
• Application Submission – Submit Form MD-14 (application) via the SUGAM portal.
• Fee Payment – Pay the applicable government fee online.
• Evaluation by CDSCO – CDSCO reviews documents and may request clarifications.
• Grant of License – Form MD-15 is issued upon approval.

Phase I – Applicant Registration

• Access SUGAM Portal – Visit the official CDSCO SUGAM portal for regulatory applications.
• Create Account – Choose the appropriate applicant type (importer/agent) and fill in registration details.
• Provide Organizational Details – Enter company name, address, and authorized personnel information.
• Upload Documents – Submit required documents like authorization letter, ID proof, and undertaking.
• Submit Registration Form – Complete and submit the online form for review.
• CDSCO Verification – CDSCO reviews the application and may request clarifications.
• Account Approval – Once approved, login credentials are issued for further application processes.

Phase II – Medical Device Import License Application

• Log in to SUGAM Portal – Use approved credentials to access the portal.
• Select Application Type – Choose Form MD-14 for medical device import license application.
• Enter Product Details – Provide device name, class, intended use, model numbers, and manufacturing site details.
• Upload Required Documents – Submit Device Master File (DMF), Plant Master File (PMF), Free Sale Certificate, ISO/CE certificate, and Power of Attorney.
• Pay Application Fee – Make payment as per device classification (Class A, B, C, or D).
• Submit Application – Finalize and submit the application for CDSCO review.
• Track Status – Monitor the application progress through the SUGAM portal.

Phase III – Review from CDSCO

• Application Scrutiny – CDSCO reviews the submitted Form MD-14 and supporting documents.
• Document Verification – Authorities check the completeness, accuracy, and authenticity of documents like DMF, PMF, and certificates.
• Technical Evaluation – CDSCO may involve Subject Expert Committees (SEC) for safety, quality, and performance assessment.
• Query Communication – If needed, CDSCO raises queries or requests additional information via the SUGAM portal.
• Applicant Response – Applicant must address queries promptly with proper documentation.
• Final Assessment – CDSCO performs a final risk and compliance review.
• Decision Notification – Approval or rejection is communicated through the portal.

Phase IV – License Approval

• Final Review Completion – CDSCO completes assessment of all submitted documents and responses.
• Approval Decision – If all regulatory and technical requirements are met, the application is approved.
• Issuance of License – Import License is granted in Form MD-15 for the approved medical device(s).
• Download License – The applicant can download the approved license from the SUGAM portal.
• Validity – The license is valid for five years, unless suspended or cancelled.
• Post-Approval Compliance – License holders must ensure ongoing regulatory compliance, including import records and adverse event reporting.
• Renewal Reminder – Begin renewal process before license expiry.

Timeline to Get MD 15 from CDSCO

The timeline to obtain an Import License (Form MD-15) from CDSCO typically ranges from 6 to 9 months after the submission of a complete and accurate application. Factors influencing this timeline include the completeness of the application, the complexity of the device, and the classification (Class A, B, C, or D). Devices with higher risk classifications or novel technologies may require additional review time. Delays can occur if CDSCO raises queries or requests further documentation. Additionally, applicants must factor in the time taken to respond to any questions or provide additional evidence when calculating the overall timeline.

Important Documents for MD-15 Import License

Important documents required for obtaining the MD-15 Import License from CDSCO include:

• Application Form MD-14 – Completed and signed by the applicant.
• Free Sale Certificate – Issued by the regulatory authority of the exporting country.
• Device Master File (DMF) – Detailed technical and regulatory information about the device.
• ISO 13485 Certification – Valid certificate indicating compliance with quality management standards.
• CE Marking or Other Regulatory Approvals – Proof of compliance with international standards (if applicable).
• of Attorney – Granting authorization to the Indian agent or importer.
• Product Labeling – Labeling, including instructions for use and safety warnings.

Validity and Renewal of Import License

The Import License (Form MD-15) granted by CDSCO is valid for five years from the date of issuance. During this period, the license holder must ensure continuous compliance with regulatory requirements, including reporting adverse events and maintaining records of imports. Before the license expires, the holder must apply for renewal by submitting a renewal request along with updated documentation and payment of applicable fees. The renewal process is similar to the initial application and involves review by CDSCO to ensure ongoing compliance with safety, quality, and regulatory standards. Timely renewal is crucial to avoid disruptions in the importation of medical devices.

Key Tips Before Applying for Medical Device Import License

Before applying for a Medical Device Import License, consider these key tips:

• Device Classification – Determine the correct classification (Class A, B, C, D) as it impacts documentation and review timelines.
• Prepare Complete Documentation – Ensure all required documents (Free Sale Certificate, ISO/CE certification, Device Master File) are accurate and up-to-date.
• Authorized Agent – Appoint a reliable, authorized Indian agent to handle the application if you’re a foreign manufacturer.
• Compliance with Standards – Verify that your device complies with Indian regulatory standards, including labeling and quality requirements.
• Understand Fees – Be aware of applicable fees for submission and renewal.
• Stay Updated – Monitor regulatory changes and CDSCO guidelines to avoid errors.