MD-14 and MD-26 Explained: Import License Documents, Process, and Timelines for India

For any Foreign Medical Device company seeking to sell its devices in India, obtaining an Import License from CDSCO is a mandatory Regulatory requirement. The two central application forms in this process are MD-14 and MD-26 —that many international companies encounter for the first time when entering the Indian market.

Understanding exactly what MD-14 and MD-26 require, how are they differerent, and how to navigate the application process efficiently can -make  the difference between a smooth market entry and months of avoidable delay. This article provides a complete, practical guide to both forms.

What Is an Import License under MDR 2017?

In India Medical Devices are governed by two important institutions:

India’s Medical Devices Rules, 2017 (MDR 2017) – govern the Import, manufacture, and sale of Medical Devices in India. Under MDR 2017, any person who intends to import a Medical Device into India must obtain an Import License from the Central Drugs Standard Control Organisation (CDSCO).

 Drugs and Cosmetics Act, 1940 — the parent legislation under which Medical Devices are regulated

The import license regime is built around two key forms:

• MD-14: Application for grant of import license for Medical Devices already approved in a reference country
• MD-26 Application for grant of permission to Import or manufacture for sale or for distribution of Medical Device which does not have predicate Medical Device in India 

A common misconception is that MD-14 applies to all imports. In fact, MD-26 is required specifically when importing a device that CDSCO classifies as a New Device or when the device has not been approved in any IMDRF-member reference country.

MD-14: Import License for Standard Medical Devices

Who Uses MD-14?

MD-14 is the standard Import license application form used by importers of Class A (sterile and measuring), B, C, and D Medical Devices that already have Regulatory approval in a reference country recognised by India — such as the US (FDA), EU (CE marking under MDR), Australia (TGA), Canada (Health Canada), or Japan (PMDA).

Key Documents Required for MD-14

The MD-14 application must be supported by a complete technical dossier. The core documents include:

• Form MD-14 duly filled and signed
• Power of attorney
• Proof of approval or marketing authorisation in the reference country (e.g., FDA 510(k), CE Certificate, TGA approval)
• Certificate of Free Sale (CFS) from the country of manufacture (origin)
• Device Master File or Technical Dossier (covering design, materials, manufacturing process, testing, labelling)
• Declaration of Conformity
• Test reports including performance, safety, and biocompatibility data
• Labelling and Instructions for Use (IFU) as proposed for the Indian market
• Authorised Agent appointment letter (if the foreign manufacturer does not have a registered Indian entity)
• Power of Attorney from the foreign manufacturer
• Site Master File or manufacturing site details
• ISO 13485 certificate of the manufacturer

Every field in the MD-14 form — model numbers, Device names, shelf life, intended use — must match exactly across all supporting documents. Even minor inconsistencies between the form and the Device Master File are one of the top triggers for CDSCO queries and delays.

The MD-14 Submission and Review Process

MD-14 applications are submitted through CDSCO’s online SUGAM portal. After submission:

1. Application is assigned to a CDSCO reviewer
2. Queries may be raised — the applicant typically has 30 days to respond
3. Inspection of the manufacturing site may be called for Class C and D devices
4. Import license is issued upon satisfactory review

Figure1

These timelines assume a complete, query-free application. Incomplete submissions or repeated queries can significantly extend these durations.

Who Needs a Medical Device Import License?

Any foreign manufacturers planning to sell Medical Devices in India cannot apply directly to CDSCO. As per the Indian law foreign manufacturers can submit the application through an Authorized Indian Agent (AIA). This is the first step as it will take the Regulatory responsibility for the device in India.

Without an Authorized Indian Agent, Import license applications cannot be filed under the Medical Device Rules, 2017. This requirement is non-negotiable for foreign manufacturers.

MD-26: Import License for New Medical Devices

When Is MD-26 Required?

MD-26 is mandatory when the Device being imported falls into one of the following categories:

• The device is a New Device as defined under MDR 2017 (not previously approved or sold in India)
• The device is not approved in any IMDRF-member reference country
• The device involves a new intended use, new technology platform, or novel materials that require additional scrutiny

Additional Requirements for MD-26

In addition to the core documentation required for MD-14, an MD-26 application must include:

• Clinical investigation data or clinical evaluation report (CER) demonstrating safety and performance in the intended Indian patient population
• Risk-benefit analysis specific to Indian use conditions
• Post-market surveillance plan
• In some cases, local clinical investigation data if the device has not been approved elsewhere

For truly novel devices with no global approval, CDSCO may require Clinical Trials or investigations to be conducted under SUGAM before granting Import approval. Early engagement with CDSCO through a pre-submission meeting is strongly recommended in these cases.

The Forms one must know — MD-14 and MD-26

Table1

Common Errors That Delay Import License Applications

Based on practical experience with hundreds of CDSCO submissions, the following are the most frequent causes of queries, rejection, and delay:

• Submitting an MD-14 when MD-26 is the correct form for the Device category
• Certificate of Free Sale that has expired or does not cover India as an Export destination
• Labelling that does not comply with MDR 2017 labelling requirements (missing mandatory fields such as manufacturer’s name and address, manufacturing date, shelf life, storage instructions)
• Test reports that are outdated or not conducted in accredited laboratories
• Authorised Agent letter that is improperly drafted or lacks sufficient authority
• Incomplete device master file — particularly missing biocompatibility data for patient-contacting devices
• Absence of post-market surveillance and vigilance details

Practical Tips for a Smooth Application

• Conduct a pre-submission review of all documents against the CDSCO checklist before portal upload
• Verify device classification before determining whether MD-14 or MD-26 applies
• Appoint an experienced Authorised Agent in India who understands CDSCO query management
• Ensure the Certificate of Free Sale explicitly names India or states ‘available for export worldwide’
• Engage a regulatory consultant for Class C and D applications — the investment in preparation significantly reduces timeline risk

Conclusion

MD-14 and MD-26 are the gateway to the Indian Medical Device market for any foreign manufacturer. While the process is structured and navigable, it demands thorough documentation preparation and a clear understanding of CDSCO’s requirements. Companies that invest in Regulatory-readiness before submission consistently achieve faster, cleaner approvals.