- One form, one license: Form MD-14 is the application; Form MD-15 is the import license CDSCO grants once it is approved.
- Central authority only: every device class needs Form MD-15 through CDSCO in Delhi, unlike manufacturing licenses, which can be State-issued.
- Real government fees: taken from the official Second Schedule of the Medical Devices Rules, 2017, from $50 per Class A device to $1,500 per Class C/D device.
- Perpetual, with a catch:MD-15 never expires on its own, but it lapses if you skip the five-year retention fee.
Introduction
An MD-14 and MD-15 registration consultant prepares and files Form MD-14, the application submitted by an Indian authorized agent to CDSCO for importing a medical device, and manages the application until CDSCO grants Form MD-15, the medical device import license.
The consultant can assist with preparing the Device Master File (DMF), Plant Master File (PMF), Power of Attorney, Free Sale Certificate (FSC) and fee payment, as well as tracking CDSCO queries and responses throughout the application process.
The applicable approval timeline, license validity and retention requirements depend on the current CDSCO rules and the specific application. The sections below cover the fees, required documents, registration process and timeline, based on the applicable CDSCO requirements, including the Second Schedule and CDSCO guidance.
What Are Form MD-14 and Form MD-15?
Under the Medical Devices Rules, 2017, the import of medical devices for sale or distribution is regulated through the Central Licensing Authority (CLA). CDSCO identifies Form MD-14 as the application for an import license and Form MD-15 as the license granted by the CLA.
Form MD-14 is the application submitted by the Indian authorized agent through the CDSCO online portal to obtain permission to import medical devices from an overseas manufacturer.
Form MD-15 is the import license issued by CDSCO after the application and supporting documents are reviewed and found satisfactory. The license covers the applicable overseas manufacturer, manufacturing site and approved medical devices.
MD-14 starts the application process, while MD-15 is the import license granted at the end of the process.
Important Exception for Class A Medical Devices
Not every Class A medical device follows the full MD-14/MD-15 licensing route. Under the 2022 amendment, Class A medical devices that are non-sterile and non-measuring were exempted from the licensing requirements, subject to the applicable registration requirements. CDSCO lists this exemption in its Medical Devices Rules section.
Therefore, always confirm the device's classification and whether the exemption applies before starting an MD-14 application.
Who Needs an MD-14 and MD-15 Registration Consultant?
Hiring a consultant is not itself a legal requirement. An eligible applicant can file the application directly. However, professional assistance can be useful when the application involves multiple products, manufacturing sites or extensive technical documentation.
| Your Situation | Consultant Useful? | Why |
|---|---|---|
| First-time overseas manufacturer entering India | Often yes | The application involves an Indian authorised agent, Power of Attorney and technical documentation |
| Class C or D device import | Often yes | Higher-risk devices can involve more detailed regulatory review |
| Multiple devices or manufacturing sites | Yes | Product and site-wise documentation and fee calculations can become complex |
| Existing MD-15 holder adding another device | Depends | An endorsement/additional-product application may be more straightforward when existing documents are current |
| Non-sterile, non-measuring Class A device | Usually not for MD-14/MD-15 | The applicable exemption means the full import-licence route may not apply |
| Existing MD-15 holder approaching retention | Depends | The company must complete the applicable retention requirements and keep supporting documents current |
Who Can Apply for an MD-15 Import License?
For a standard medical-device import application, the Indian authorized agent submits Form MD-14 to the Central Licensing Authority.
The CDSCO checklist identifies the authorized agent's supporting credentials, including a wholesale license, manufacturing license or Form MD-42 registration certificate, as applicable.
The overseas manufacturer appoints the Indian party as its authorized agent through a Power of Attorney. The Power of Attorney must meet the authentication requirements under the Medical Devices Rules.
If a consultant is handling the application, the applicant should still maintain control over its regulatory account and ensure that the consultant has the appropriate authorization to act on its behalf.
What Documents Are Required for Form MD-14?
CDSCO's current checklist for an MD-15 import-license application includes the following key documents:
- Form MD-14 application
- Fee challan
- Power of Attorney from the overseas manufacturer, along with the authorised agent's undertaking and required authentication
- Copy of the authorised agent's wholesale licence, manufacturing licence or Form MD-42 registration certificate, as applicable
- Constitution details of the authorised agent
- Applicable Free Sale Certificate/Marketing Authorisation
- Overseas manufacturing-site or establishment registration, where applicable
- Relevant inspection or audit report, where available/applicable
- Quality Management System certificate and other applicable quality certificates
- Declaration of Conformity
- Plant Master File (PMF) from the manufacturer
- Device Master File (DMF) from the manufacturer
- Labels and Instructions for Use (IFU)
- Other technical documents required under the applicable Fourth Schedule
The exact checklist can vary according to the device and application pathway, so applicants should always check the latest CDSCO checklist and portal requirements before filing.
Where Applications Commonly Need Attention
Two documents that deserve particular care are the Power of Attorney and Free Sale Certificate/Marketing Authorisation. The names and addresses of the legal manufacturer, actual manufacturing site and authorised parties should be consistent across the application and supporting documents.
A consultant can help identify these inconsistencies before submission and reduce avoidable CDSCO queries.
What Is the Step-by-Step Process to Get Form MD-15?
1. Confirm the device classification
First, determine whether the medical device is Class A, B, C or D under the applicable CDSCO classification requirements. This can affect the regulatory pathway and applicable fees.
2. Appoint the Indian authorized agent
The overseas manufacturer must appoint an eligible Indian authorised agent and execute the required Power of Attorney.
3. Prepare the technical documents
Prepare the Device Master File, Plant Master File, quality certificates, labels, IFU, regulatory certificates and other documents required for the application.
4. Complete the portal requirements
Create or confirm the required applicant information on the CDSCO Medical Devices Online/SUGAM system and prepare the application for submission.
5. Submit Form MD-14
File Form MD-14 with the applicable documents and pay the fee prescribed under the Second Schedule. CDSCO's current medical-device page confirms that MD-14 is the application route for an MD-15 import licence.
6. Respond to CDSCO queries
CDSCO may raise deficiency or clarification queries during its review. The applicant must provide the required response and supporting documents.
7. Support inspection, where applicable
Depending on the application and regulatory requirements, CDSCO may require an inspection or additional review of the overseas manufacturing site.
8. Receive Form MD-15
Once the application is approved, CDSCO grants the Form MD-15 import licence.
For certain applications, additional product endorsement or subsequent-import pathways may also use Form MD-14 and MD-15, so the exact route should be checked against the applicable CDSCO requirements.
How Long Is an MD-15 Import License Valid?
An important correction to the earlier wording is that an MD-15 license is not simply a five-year license that expires after five years.
The Medical Devices Rules provide for the license to remain valid in perpetuity, subject to payment of the applicable license retention fee after every five years and continued compliance with the rules. CDSCO guidance also describes the retention process as part of the import-license lifecycle.
Therefore, the five-year period is linked to license retention requirements, not an automatic five-year expiry of the license itself.
What Are the MD-14 and MD-15 Fees, Validity and Retention Requirements?
The MD-14 application and MD-15 import license fees are prescribed in the Second Schedule of the Medical Devices Rules, 2017. The fee structure is generally based on the overseas manufacturing site and each distinct medical device, with separate provisions for IVDs.
| Device Class | Fee at Grant of MD-15 | Validity | Retention Fee Every 5 Years |
|---|---|---|---|
| Class A – Non-IVD | $1,000 per site + $50 per device | Perpetual, subject to retention | $1,000 per site + $50 per device |
| Class B – Non-IVD | $2,000 per site + $1,000 per device | Perpetual, subject to retention | $2,000 per site + $1,000 per device |
| Class C or D – Non-IVD | $3,000 per site + $1,500 per device | Perpetual, subject to retention | $3,000 per site + $1,500 per device |
| IVD – Class A or B | $1,000 per site + $10 per device | Perpetual, subject to retention | $1,000 per site + $10 per device |
| IVD – Class C or D | $3,000 per site + $500 per device | Perpetual, subject to retention | $3,000 per site + $500 per device |
| Overseas site inspection | $6,000 | One-time | Not applicable |
| Import for test, evaluation or demonstration | $100 per device | As applicable to the licence | Not applicable |
The current CDSCO rules separately specify the site and product fees and the corresponding license retention fees.
How Are These Fees Calculated?
The site fee applies to the relevant overseas manufacturing site, while the device fee applies to each distinct medical device covered by the application.
For example, if an applicant imports two distinct Class B non-IVD medical devices from one overseas manufacturing site, the basic application fee would be:
$2,000 site fee + (2 × $1,000 device fee) = $4,000
The classification of a product as a distinct device should be determined using the applicable CDSCO Medical Device Grouping Guidelines.
Important: The exact fee should always be checked against the current Second Schedule and the applicable device category before payment.
Is the MD-15 Import License Valid for 5 Years?
No. MD-15 does not simply expire after five years.
The Medical Devices Rules provide for the import license to remain perpetually valid, subject to the applicable license retention fee being paid every five years. CDSCO's FAQ also confirms that an import license continues to be valid until suspension or cancellation when the required retention fee is paid.
Therefore, the five-year period is a retention requirement, not the expiry period of the MD-15 licence.
How Long Does It Take to Get Form MD-15?
The expected timeline depends on the completeness of the application, CDSCO's review, queries and whether an overseas site inspection is required.
| Stage | Timeline / Requirement | Practical Note |
|---|---|---|
| MD-14 application review | As prescribed under the applicable rules | Complete documentation can help reduce avoidable queries |
| Overseas site inspection, if required | As scheduled by CDSCO | May affect the overall processing time |
| Deficiency or clarification queries | As communicated by CDSCO | Respond as quickly and completely as possible |
| Post-approval changes | Follow the applicable MDR requirement | Some changes require prior approval or a fresh application |
About the “9-Month” Timeline
Do not present nine months as a guaranteed approval time. The applicable rules provide a regulatory timeframe for disposal of the application, but the actual case can take longer when there are deficiencies, additional information requests, inspection requirements or other regulatory issues.
The quality of the initial submission is therefore important. In particular, make sure the Power of Attorney, Free Sale Certificate/Marketing Authorization, manufacturer details, site details and technical files are consistent before submission.
What Happens After MD-15 Is Granted?
Obtaining MD-15 is not the end of compliance. The license holder may need to make additional submissions when products, manufacturing arrangements or other license details change.
Adding a New Device
Where an additional device is being added to an existing license, the applicable endorsement procedure, fee and supporting documents should be followed. The exact route depends on the circumstances of the additional device and manufacturing site.
Changing the Authorized Agent
A change in the authorized agent can require a new import-license application or other regulatory action, depending on the circumstances. Do not treat this as a routine profile edit without checking the applicable CDSCO requirement.
Change in Constitution
If there is a change in the constitution of the license holder, the Medical Devices Rules prescribe specific notification and application requirements. The applicable timelines should be followed based on the nature of the change.
Change in Overseas Manufacturing Site
A change involving the overseas manufacturing site may require regulatory approval, endorsement or a fresh application depending on the nature of the change. The applicable CDSCO procedure should be confirmed before implementing the change.
Five-Year License Retention
The MD-15 holder must pay the applicable license retention fee every five years to maintain the license's continuing validity. Keep the retention date in a compliance calendar and complete the required submission within the prescribed period.
Post-Marketing Compliance
An MD-15 holder must also comply with applicable post-marketing surveillance and reporting requirements under the Medical Devices Rules and relevant CDSCO directions.
How Should You Choose an MD-14 and MD-15 Registration Consultant?
The quality of an MD-14/MD-15 consultant often becomes most visible when CDSCO raises queries. Use the following questions when comparing consultants:
| Ask This | What a Strong Answer Looks Like |
|---|---|
| Have you handled my device class before? | Relevant experience with the applicable Class A, B, C or D pathway |
| How will you check the Free Sale Certificate and Power of Attorney? | A document-by-document review against current CDSCO requirements |
| What is included in your professional fee? | Clear scope covering preparation, filing, query responses and agreed post-approval support |
| Are government fees separate? | Government fees are clearly identified separately from professional fees |
| Who controls the portal login and original documents? | The applicant/company retains control |
| How will you manage the five-year retention? | A clear retention calendar and reminder system |
| What happens if CDSCO raises queries? | Query review and response support are clearly defined in the engagement |
A Good Consultant Should Provide More Than Just Filing
A reliable consultant should help with document consistency, application preparation, regulatory queries, fee calculation and post-approval compliance, rather than simply uploading documents to the CDSCO portal.
Most importantly, avoid anyone promising “guaranteed approval.” The final decision remains with the Central Licensing Authority/CDSCO, based on the applicable rules and review of the application.
Talk to an MD-14 and MD-15 Registration Consultant
If you are planning to import a medical device into India, the first step is to confirm the device's risk class and determine whether it requires the full MD-14 to MD-15 import license process or qualifies for the applicable Class A registration exemption.
Share your product details, overseas manufacturing site and available documents, and the MD-14 and MD-15 registration consultants at Silvereye Certifications can help you understand the applicable fees, timeline, documentation and filing process for your specific case.
Need help with your medical device import licence? Contact Silvereye Certifications for professional assistance with MD-14 and MD-15 registration.
Frequently Asked Questions
What is Form MD-14 used for?
Form MD-14 is the application an Indian authorized agent files with CDSCO to seek permission to import a medical device manufactured outside India. It is filed with Fourth Schedule documents and the fee prescribed in the Second Schedule.
What is Form MD-15?
Form MD-15 is the import license CDSCO grants once the MD-14 application, documents and site are found satisfactory. It names the overseas manufacturer, the site and the approved device.
How long does the MD-15 import license take?
The Medical Devices Rules allow up to nine months for grant, provided the documents submitted are satisfactory. Deficiency queries can extend this.
Who can apply for Form MD-14?
Any firm or organization holding a valid manufacturing license, a wholesale license, or a Form MD-42 registration certificate can act as the Indian authorized agent and apply.
Do all medical devices need MD-14 and MD-15?
No. Class A devices that are both non-sterile and non-measuring are exempt and need only a free portal registration instead of the full import license.
What documents are required for Form MD-14?
Key documents include the power of attorney, Free Sale Certificate, Device Master File, Plant Master File, quality management system certificate, labels and Instructions for Use, and the agent's existing licence or registration.
Is Form MD-15 valid for life?
Yes, it is perpetually valid until suspended or cancelled, as long as the licensee pays the retention fee every five years and complies with the license conditions.
What happens if I do not pay the retention fee on time?
A late fee applies for a limited grace period; beyond that, the import license can be treated as cancelled, so it is important to track the five-year deadline from the date of issue.
Can one MD-14 application cover multiple devices?
Yes, but a separate fee applies for each distinct medical device and each brand, as calculated under CDSCO's grouping guidelines.
Does changing my Indian authorized agent affect my MD-15 license?
Yes. CDSCO requires a fresh import licence application when the authorised agent changes.
Will CDSCO inspect my overseas manufacturing site?
CDSCO may inspect the overseas site before or after granting the import license, when it considers this necessary. There is a separate government fee if this inspection takes place.
Can I get a refund if I withdraw my MD-14 application?
No. The Medical Devices Rules make no provision for refunding the fee already paid, even if the application is withdrawn.
