India’s medical device import landscape is governed by a structured regulatory framework under the Central Drugs Standard Control Organisation (CDSCO)—the country’s apex regulatory body for pharmaceuticals and medical devices. Whether you’re a foreign manufacturer or an Indian importer, understanding Form MD-26 and Form MD-27 is essential to legally introduce medical devices into the Indian market.
This article provides a comprehensive overview of these forms, their legal context, application process, document checklist, and compliance obligations under the Medical Devices Rules, 2017.
About CDSCO and Medical Device Regulation in India
The Central Drugs Standard Control Organisation (CDSCO) operates under the Ministry of Health and Family Welfare and is responsible for regulating the import, manufacture, sale, and distribution of drugs and medical devices across India.
Key responsibilities include:
- Approval of medical devices and diagnostics.
- Granting import licenses.
- Conducting inspections and audits.
- Ensuring post-market surveillance and safety compliance.
All medical devices, especially those classified under Class A, B, C, or D, must comply with the provisions of the Medical Devices Rules, 2017, and require registration through CDSCO’s SUGAM Portal.
Purpose and Applicability of Form MD-26 and Form MD-27
● Form MD-26: Application for Import License
Form MD-26 is submitted to apply for a license to import medical devices into India. It is the first step toward obtaining approval for devices not manufactured in India but intended for sale or distribution within the country.
● Form MD-27: Grant of Import License
Form MD-27 is the official import license issued by CDSCO after the evaluation of MD-26 and accompanying documents. This form permits the applicant to import and distribute the device in accordance with Indian regulations.
These forms are mandatory for all entities involved in the import of regulated medical devices, especially Class B, C, and D devices, which are subject to stricter regulatory scrutiny.
Who Can Apply?
The following categories of entities are eligible to apply for medical device import permissions under the Medical Devices Rules, 2017:
- Indian Manufacturers
Domestic companies such as:- Private Limited Companies
- Limited Liability Partnerships (LLPs)
- Public Limited Companies
involved in the manufacturing of medical devices in India who intend to import: - Finished medical devices for further distribution, or
- Components/raw materials for in-house assembly or production.
- Authorized Indian Agents
These are Indian-registered firms appointed by foreign manufacturers to act on their behalf in regulatory matters. The agent must:- Hold a valid license.
- Be registered on the CDSCO SUGAM portal.
- Be responsible for filing and maintaining regulatory records.
- Importers
Entities focused solely on importing medical devices for commercial sale or use. These companies:- Do not manufacture domestically.
- Must demonstrate authorized access to the manufacturing data and regulatory certificates from the original manufacturer.
- Distributors and Wholesalers
Indian businesses intending to:- Procure and distribute imported medical devices to hospitals, clinics, diagnostic centers, or retailers.
- They may apply for import licenses if importing directly or work under agreements with authorized importers or manufacturers.
- Authorized Representatives (ARs)
Companies that serve as regulatory representatives of foreign manufacturers, especially where the foreign company has no physical presence in India. ARs:- Must be formally appointed via a notarized Power of Attorney.
- Are accountable for legal and regulatory compliance on behalf of the overseas entity.
Note: Foreign companies cannot apply directly to CDSCO. They must operate through an Indian Authorized Agent or Representative.
Key Regulatory Benefits of Import Licensing
Obtaining CDSCO import approval via Forms MD-26 and MD-27 provides:
- Regulatory Assurance: Confirms compliance with Indian safety and quality standards.
- Market Access: Grants legal entry into the Indian market for foreign-manufactured devices.
- Brand Credibility: Enhances trust among hospitals, healthcare professionals, and consumers.
- Post-Market Legitimacy: Ensures eligibility for tenders, partnerships, and supply chain contracts.
- Business Continuity: Avoids legal risks or seizure of unregistered devices by enforcement authorities.
Required Documents for Form MD-26 and MD-27
A robust application must include:
Applicant & Manufacturer Details
- Cover letter with application purpose
- Constitution of the firm (e.g., partnership deed, Certificate of Incorporation)
- Details of manufacturing facility and plant registration
Technical Documentation
- Device specifications and product labels
- Instructions for use and brochures
- Regulatory approvals (e.g., US FDA, CE Certificate, TGA approval)
Quality and Compliance Evidence
- ISO 13485 Certificate
- Free Sale Certificate from country of origin
- Undertaking of conformity to Indian standards
- Device Master File (DMF) and Plant Master File (PMF)
For Foreign Manufacturers:
- Power of Attorney appointing the Indian Authorized Agent
- Importer Agreement
- Storage and distribution details in India
Incomplete or improperly compiled documents often result in application delays or rejection.
Application Process on the CDSCO SUGAM Portal
Step-by-Step Procedure:
- Registration on CDSCO’s SUGAM portal by the importer or authorized agent.
- Online submission of Form MD-26 with supporting documents.
- Fee payment as prescribed under the Medical Devices Rules, 2017.
- Technical review by CDSCO officials; may include request for additional information.
- Inspection, especially for Class C and D devices.
- Issuance of Form MD-27, if all criteria are met.
Applicants must ensure that all documents are digitally signed and uploaded correctly. Physical document submission may be requested in some cases.
Device Classification and Its Impact on Approval
CDSCO classifies medical devices into four categories:
| Class | Risk Level | Regulatory Oversight |
|---|---|---|
| A | Low | Self-declaration; minimal CDSCO involvement |
| B | Low to Moderate | Licensed by State Licensing Authority (SLA) |
| C | Moderate to High | CDSCO + potential site inspection |
| D | High | CDSCO + stringent scrutiny and testing |
For Class C and D devices, CDSCO may refer the application to its Subject Expert Committee (SEC) and require additional data or clinical performance evaluation before issuing Form MD-27.
Validity and Renewal of Import Licenses
- Form MD-27 remains valid perpetually, unless suspended or cancelled by CDSCO.
- However, licensees must ensure:
- Periodic compliance reporting
- Prompt submission of post-market surveillance data
- Renewal of supporting documents (ISO, FSC, etc.) if expired
Failure to maintain updated documentation or compliance can result in suspension or revocation of the import license.
Frequently Asked Questions (FAQs)
Is CDSCO registration mandatory for all medical devices?
Yes, every medical device falling under the notified list must be registered and licensed through CDSCO.
Can a foreign manufacturer apply directly for Form MD-26?
No. Foreign manufacturers must appoint an Indian Authorized Agent to file the application on their behalf.
Is inspection mandatory for all classes of devices?
Inspections are usually required for Class C and D devices, especially if the CDSCO deems the product as high-risk or lacks adequate international approvals.
How long does it take to get an import license?
Timelines vary depending on device classification and the completeness of documentation. It may take anywhere from 4 to 12 weeks.
Why Choose CertificationsBay?
At CertificationsBay, we specialize in managing end-to-end regulatory compliance for medical devices. Our services include:
- Preparing and submitting Form MD-26 and MD-27
- Technical document review and gap analysis
- Authorized agent support for foreign manufacturers
- Real-time coordination with CDSCO and SUGAM portal management
- Liaising with Subject Expert Committees and handling device classification queries
With a strong track record of regulatory approvals and industry-specific expertise, CertificationsBay ensures your device enters the Indian market faster, legally, and compliantly
Need help with Form MD-26 or MD-27?
Let CertificationsBay simplify your CDSCO registration journey. Contact our experts today for a free consultation and accelerate your medical device import process.
