Form MD-14 and MD-15 - Import License for Medical Devices in India

Form MD-14 and MD-15 - Import License for Medical Devices in India . The import and regulation of medical devices in India is governed by the Central Drugs Standard Control Organisation (CDSCO), functioning under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India. As per the Drugs and Cosmetics Act, 1940, and Medical Device Rules (MDR), 2017, importers are required to obtain proper licensing for importing medical devices into India. This involves filing Form MD-14 and MD-15, which are essential for getting import licenses for various classes of medical devices.
Introduction to CDSCO and Medical Device Licensing
The CDSCO acts as India’s National Regulatory Authority (NRA) for pharmaceuticals and medical devices. It ensures safety, efficacy, and quality standards through regulatory frameworks. Starting from April 1, 2020, CDSCO has made it mandatory for all medical devices (including non-notified ones) to be registered or licensed under the MDR. As per the updated regulations:

From October 1, 2022, Class A and B medical devices require import licenses.

From October 1, 2023, the same applies to Class C and D devices.

What is Form MD-14 and Form MD-15?
Form MD-14 is the application form that must be submitted to the Central Licensing Authority (CLA) to request permission to import medical devices into India. The application is made either by an Indian manufacturer or an authorised agent on behalf of a foreign manufacturer.
Form MD-15 is the actual import license issued by the CLA once Form MD-14 is approved. This license permits the import of medical devices categorized into Classes A, B, C, or D based on the associated risk.
These forms are pivotal for regulating the entry of medical devices into the Indian market and ensuring only certified and safe products are made available for use.
Classification of Medical Devices in India
The following is the classification of Medical Devices in India:

Class A: Low risk (e.g., thermometers, surgical dressings)

Class B: Low to moderate risk (e.g., syringes, infusion pumps)

Class C: Moderate to high risk (e.g., dialysis machines)

Class D: High risk (e.g., heart valves, defibrillators)

Each class requires specific documentation, inspection, and regulatory compliance. Licensing under Form MD-14 and MD-15 becomes increasingly stringent with the class level.
Requirement for CDSCO Registration and Import License
Importing a medical device without CDSCO Registration is prohibited under Indian regulations. Devices must be registered using a unique device identifier (UDI), and documentation such as the Device Master File (DMF) and Plant Master File (PMF) is required for import license approval.

The DMF includes detailed product specifications, clinical data, and labeling information.

The PMF contains manufacturing facility details, quality control protocols, and other plant-specific information.

Medical devices that are not yet notified must still be registered as Non-Regulatory Products until a notification is issued.
Eligibility Criteria to File Form MD-14 and MD-15
To apply for an import license using Form MD-14, the applicant must be:

A foreign manufacturer with an authorised Indian agent.

The Indian agent must hold a valid wholesale license in Form 20B and Form 21B.

The authorised agent acts on behalf of the foreign manufacturer and is responsible for ensuring compliance with Indian regulations, including post-market surveillance.
Role of Authorised Agent or Registration Holder
Foreign manufacturers cannot directly apply to the CDSCO without a local presence in India. Hence, they must appoint an authorised agent who has:

A valid drug wholesale/manufacturing license.

Registered office in India.

Authorization letter to represent the foreign firm.

The authorised agent is accountable for documentation, submissions, query handling, and all correspondence with CDSCO.
Procedure for Obtaining Import License Using Form MD-14 and MD-15
Step 1: Product Evaluation
Check if the device falls under the MDR 2017 framework. Non-notified medical devices must still be registered.
Step 2: Risk Classification
Identify the class of your device (A, B, C, or D). This classification determines the level of documentation and scrutiny required.
Step 3: Documentation Preparation
Documents required include:

DMF

PMF

Authorization letter

ISO 13485 certificate

Free Sale Certificate

Undertaking for post-market surveillance

Step 4: Application Submission (Form MD-14)
The authorised agent prepares the online application through the CDSCO portal and uploads all required documents. Draft applications are reviewed and finalized by the agent.
Step 5: Fee Payment
Fees are paid as per the device class and number of devices applied for.
Step 6: Approval and Issuance of Form MD-15
Once the CDSCO approves Form MD-14, they issue Form MD-15, which is the import license.
Validity of Form MD-15
The import license granted via Form MD-15 is valid for lifetime, provided the retention fee is paid every five years, in accordance with the Second Schedule of the MDR. If not renewed, the license may be cancelled or suspended by the CLA.
Importance of Form MD-14 and MD-15

Regulatory Compliance: Ensures that only quality-verified medical devices are imported into India.

Market Authorization: Without Form MD-15, it is illegal to import and sell devices in India.

Traceability and Safety: Helps track the origin and quality of medical devices.

Post-Market Obligations: The authorised agent is responsible for adverse event reporting and product recalls if needed.

Fees Structure (As per CDSCO)
Fees vary depending on the classification and the number of devices:

Class A and B: Lower fees

Class C and D: Higher fees due to higher risk and regulatory evaluation

These fees must be paid at the time of submitting Form MD-14.
Renewal and License Retention
Although Form MD-15 has perpetual validity, it requires payment of a retention fee every five years. If the retention fee is not paid, the license becomes inactive.
Challenges in Form MD-14 and MD-15 Filing

Complexity in compiling DMF and PMF

Delays due to insufficient or incorrect documentation

Lack of clarity on classification for borderline devices

Changes in regulatory guidelines requiring constant updates

Onilne Process and Filing
CDSCO has digitized the process for filing Form MD-14 and MD-15 through its SUGAM portal:

Registration and login by authorised agent

Uploading of documents

Online payment of government fees

Real-time tracking and response to queries from licensing officers

Post-License Compliances
After obtaining Form MD-15, the following are required:

Annual performance report submission

Product quality surveillance

Intimation to CDSCO in case of product discontinuation

Regular updates if there are changes in manufacturing or labeling

Conclusion
Obtaining an import license using Form MD-14 and MD-15 is a mandatory and regulated process to ensure that only certified, safe, and high-quality medical devices are brought into the Indian market. By appointing a qualified authorised agent, preparing accurate documents like DMF and PMF, and following the CDSCO's digital process, the licensing can be done smoothly. While Form MD-14 initiates the process, Form MD-15 marks the official grant of permission to import medical devices into India.
Failure to comply with these procedures can result in penalties, import bans, or product recalls.
FAQ's
Q1. What is Form MD-14 used for? 
Ans. Form MD-14 is an application form submitted to the Central Licensing Authority (CLA) to seek permission to import medical devices into India. It must be filled out by an authorised Indian agent on behalf of a foreign manufacturer.
Q2. What is Form MD-15 in CDSCO regulations?
Ans. Form MD-15 is the official import license granted by the Central Licensing Authority (CLA) after the application made through Form MD-14 is approved. It authorizes the import of specific medical devices into India.
Q3. Who can file Form MD-14 and MD-15?
Ans. Only an authorised Indian agent who holds a valid wholesale or manufacturing license (Form 20B and Form 21B) can file Form MD-14 and MD-15 on behalf of a foreign manufacturer.
Q4. What is the validity period of Form MD-15?
Ans. Form MD-15 is valid for a lifetime, provided that the license retention fee is paid every five years from the date of issue as per the Second Schedule of the Medical Device Rules, 2017.
Q5. What are the key documents required for filing Form MD-14?
Ans. The essential documents include the Device Master File (DMF), Plant Master File (PMF), Free Sale Certificate, ISO 13485 certificate, an authorization letter from the manufacturer, and a copy of the wholesale license.
Q6. Can one Form MD-14 be used for multiple medical devices?
Ans. Yes, multiple medical devices can be included in a single Form MD-14 application, but the fees and documentation requirements will increase proportionally with the number of devices listed.
Q7. Is online filing available for Form MD-14 and MD-15?
Ans. Yes, CDSCO has enabled online application submission through its SUGAM portal, where authorised agents can upload documents, pay fees, track the application, and respond to queries electronically.

The import and regulation of medical devices in India is governed by the Central Drugs Standard Control Organisation (CDSCO), functioning under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India. As per the Drugs and Cosmetics Act, 1940, and Medical Device Rules (MDR), 2017, importers are required to obtain proper licensing for importing medical devices into India. This involves filing Form MD-14 and MD-15, which are essential for getting import licenses for various classes of medical devices.

Introduction to CDSCO and Medical Device Licensing

The CDSCO acts as India’s National Regulatory Authority (NRA) for pharmaceuticals and medical devices. It ensures safety, efficacy, and quality standards through regulatory frameworks. Starting from April 1, 2020, CDSCO has made it mandatory for all medical devices (including non-notified ones) to be registered or licensed under the MDR. As per the updated regulations:

From October 1, 2022, Class A and B medical devices require import licenses.
From October 1, 2023, the same applies to Class C and D devices.

What is Form MD-14 and Form MD-15?

Form MD-14 is the application form that must be submitted to the Central Licensing Authority (CLA) to request permission to import medical devices into India. The application is made either by an Indian manufacturer or an authorised agent on behalf of a foreign manufacturer.

Form MD-15 is the actual import license issued by the CLA once Form MD-14 is approved. This license permits the import of medical devices categorized into Classes A, B, C, or D based on the associated risk.

These forms are pivotal for regulating the entry of medical devices into the Indian market and ensuring only certified and safe products are made available for use.

Classification of Medical Devices in India

The following is the classification of Medical Devices in India:

Class A: Low risk (e.g., thermometers, surgical dressings)
Class B: Low to moderate risk (e.g., syringes, infusion pumps)
Class C: Moderate to high risk (e.g., dialysis machines)
Class D: High risk (e.g., heart valves, defibrillators)

Each class requires specific documentation, inspection, and regulatory compliance. Licensing under Form MD-14 and MD-15 becomes increasingly stringent with the class level.

Requirement for CDSCO Registration and Import License

Importing a medical device without CDSCO Registration is prohibited under Indian regulations. Devices must be registered using a unique device identifier (UDI), and documentation such as the Device Master File (DMF) and Plant Master File (PMF) is required for import license approval.

The DMF includes detailed product specifications, clinical data, and labeling information.
The PMF contains manufacturing facility details, quality control protocols, and other plant-specific information.

Medical devices that are not yet notified must still be registered as Non-Regulatory Products until a notification is issued.

Eligibility Criteria to File Form MD-14 and MD-15

To apply for an import license using Form MD-14, the applicant must be:

A foreign manufacturer with an authorised Indian agent.
The Indian agent must hold a valid wholesale license in Form 20B and Form 21B.

The authorised agent acts on behalf of the foreign manufacturer and is responsible for ensuring compliance with Indian regulations, including post-market surveillance.

Role of Authorised Agent or Registration Holder

Foreign manufacturers cannot directly apply to the CDSCO without a local presence in India. Hence, they must appoint an authorised agent who has:

A valid drug wholesale/manufacturing license.
Registered office in India.
Authorization letter to represent the foreign firm.

The authorised agent is accountable for documentation, submissions, query handling, and all correspondence with CDSCO.

Procedure for Obtaining Import License Using Form MD-14 and MD-15

Step 1: Product Evaluation

Check if the device falls under the MDR 2017 framework. Non-notified medical devices must still be registered.

Step 2: Risk Classification

Identify the class of your device (A, B, C, or D). This classification determines the level of documentation and scrutiny required.

Step 3: Documentation Preparation

Documents required include:

DMF
PMF
Authorization letter
ISO 13485 certificate
Free Sale Certificate
Undertaking for post-market surveillance

Step 4: Application Submission (Form MD-14)

The authorised agent prepares the online application through the CDSCO portal and uploads all required documents. Draft applications are reviewed and finalized by the agent.

Step 5: Fee Payment

Fees are paid as per the device class and number of devices applied for.

Step 6: Approval and Issuance of Form MD-15

Once the CDSCO approves Form MD-14, they issue Form MD-15, which is the import license.

Validity of Form MD-15

The import license granted via Form MD-15 is valid for lifetime, provided the retention fee is paid every five years, in accordance with the Second Schedule of the MDR. If not renewed, the license may be cancelled or suspended by the CLA.

Importance of Form MD-14 and MD-15

Regulatory Compliance: Ensures that only quality-verified medical devices are imported into India.
Market Authorization: Without Form MD-15, it is illegal to import and sell devices in India.
Traceability and Safety: Helps track the origin and quality of medical devices.
Post-Market Obligations: The authorised agent is responsible for adverse event reporting and product recalls if needed.

Fees Structure (As per CDSCO)

Fees vary depending on the classification and the number of devices:

Class A and B: Lower fees
Class C and D: Higher fees due to higher risk and regulatory evaluation

These fees must be paid at the time of submitting Form MD-14.

Renewal and License Retention

Although Form MD-15 has perpetual validity, it requires payment of a retention fee every five years. If the retention fee is not paid, the license becomes inactive.

Challenges in Form MD-14 and MD-15 Filing

Complexity in compiling DMF and PMF
Delays due to insufficient or incorrect documentation
Lack of clarity on classification for borderline devices
Changes in regulatory guidelines requiring constant updates

Onilne Process and Filing

CDSCO has digitized the process for filing Form MD-14 and MD-15 through its SUGAM portal:

Registration and login by authorised agent
Uploading of documents
Online payment of government fees
Real-time tracking and response to queries from licensing officers

Post-License Compliances

After obtaining Form MD-15, the following are required:

Annual performance report submission
Product quality surveillance
Intimation to CDSCO in case of product discontinuation
Regular updates if there are changes in manufacturing or labeling

Conclusion

Obtaining an import license using Form MD-14 and MD-15 is a mandatory and regulated process to ensure that only certified, safe, and high-quality medical devices are brought into the Indian market. By appointing a qualified authorised agent, preparing accurate documents like DMF and PMF, and following the CDSCO's digital process, the licensing can be done smoothly. While Form MD-14 initiates the process, Form MD-15 marks the official grant of permission to import medical devices into India.

Failure to comply with these procedures can result in penalties, import bans, or product recalls.

FAQ's

Q1. What is Form MD-14 used for?

Ans. Form MD-14 is an application form submitted to the Central Licensing Authority (CLA) to seek permission to import medical devices into India. It must be filled out by an authorised Indian agent on behalf of a foreign manufacturer.

Q2. What is Form MD-15 in CDSCO regulations?

Ans. Form MD-15 is the official import license granted by the Central Licensing Authority (CLA) after the application made through Form MD-14 is approved. It authorizes the import of specific medical devices into India.

Q3. Who can file Form MD-14 and MD-15?

Ans. Only an authorised Indian agent who holds a valid wholesale or manufacturing license (Form 20B and Form 21B) can file Form MD-14 and MD-15 on behalf of a foreign manufacturer.

Q4. What is the validity period of Form MD-15?

Ans. Form MD-15 is valid for a lifetime, provided that the license retention fee is paid every five years from the date of issue as per the Second Schedule of the Medical Device Rules, 2017.

Q5. What are the key documents required for filing Form MD-14?

Ans. The essential documents include the Device Master File (DMF), Plant Master File (PMF), Free Sale Certificate, ISO 13485 certificate, an authorization letter from the manufacturer, and a copy of the wholesale license.

Q6. Can one Form MD-14 be used for multiple medical devices?

Ans. Yes, multiple medical devices can be included in a single Form MD-14 application, but the fees and documentation requirements will increase proportionally with the number of devices listed.

Q7. Is online filing available for Form MD-14 and MD-15?

Ans. Yes, CDSCO has enabled online application submission through its SUGAM portal, where authorised agents can upload documents, pay fees, track the application, and respond to queries electronically.