CDSCO Form MD-26

India imports many medical devices, and making sure they are safe is very important. Because of this, the Central Drugs Standard Control Organisation requires importers to submit Form MD-26 before bringing any regulated device into the country. This form includes key details such as product specifications, manufacturer information, device safety records, and a Free Sale Certificate from the exporting country. It helps CDSCO check that the device meets quality standards and is safe for use in India.

In this guide, you will understand what Form MD-26 includes, who needs to apply for it, what documents are required, and how the entire import license process works. Imported medical devices directly affect hospitals, clinics, patients, and healthcare outcomes, which is why proper compliance is crucial. By clearly understanding MD-26 requirements, businesses can import devices easily, avoid regulatory problems, and make sure only safe and approved products enter the Indian market.

What Is CDSCO MD-26?  

CDSCO MD-26 is the official application form used to get an import license for medical devices in India. It is issued under the Medical Device Rules, 2017, and must be submitted by any importer or authorized agent who wants to bring medical devices from a foreign manufacturer into the country. The form collects essential details about the device, including its category, purpose, safety profile, and global regulatory status. This information helps CDSCO understand the product and how it will be used in the healthcare system.  

MD-26 forms the basis for determining if a medical device is suitable for the Indian market. It allows CDSCO to check the product's compliance with quality, safety, and performance standards before giving permission to import it. Once approved, the license ensures that only verified and regulated medical devices can legally enter and be distributed throughout India.

Form MD-26 is essential for managing the safety and legality of medical device imports. It safeguards patients and ensures only compliant devices enter India.

• Verifies Manufacturer Credentials and Product Safety: MD-26 mandates importers to submit manufacturer documents and technical data. CDSCO reviews these items to ensure the foreign maker fulfills regulatory and safety regulations.
• Ensures Correct Device Classification and Labeling: The form needs device class and label details. Right classification helps CDSCO regulate applicable tests, necessary documents, and permitted claims for the product.
• Facilitates Customs Clearance and Legal Import: A valid MD-26 import license mitigates customs hold-ups. It provides customs and CDSCO clear authority to clear shipments that match official documents.
• Safeguards Public Health by Regulating Market Entry: By permitting only devices with appropriate safety evidence, MD-26 helps avoid unsafe or substandard devices from reaching patients and healthcare providers.

Who Needs a CDSCO Form MD-26 License in India?

Any importer, authorized Indian agent, distributor, or foreign manufacturer planning to bring medical devices into India must use Form MD-26 to apply for an import license. This includes companies that import finished medical devices, testing kits, or components classified as notified medical devices under the Medical Device Rules 2017. Clinical trial importers and research organizations that import regulated devices for evaluation must also use MD-26 when required.  

If you plan to sell or distribute imported devices in India, secure the MD-26 import licence or have your Indian authorized representative file it for you. Using MD-26 helps prevent customs detention and ensures the product is approved for import by CDSCO.

Obtaining an MD-26 import license provides practical and regulatory benefits for importers and suppliers. Some of the key benefits include: Getting an MD-26 import license offers practical and regulatory advantages for importers and suppliers.

• Legal Approval to Import and Sell: An approved MD-26 confers legal status to imported devices. This enables importers bring in products, clear customs, distribute, and sell while adhering to CDSCO guidelines.
• Faster Customs Processing and Fewer Holds: When you supply a valid MD-26 licence and matching documents, customs inspections and holds are less, enhancing the speed of shipments into India.
• Demonstrates Product Safety and Credibility: MD-26 needs test reports and a Free Sale Certificate, assisting buyers and hospitals to trust the product’s quality and regulatory standing in India.
• Avoids Regulatory Penalties and Seizures: Importing without correct CDSCO approval risks seizure, fines, and business disruption. MD-26 helps avoid these legal and financial risks.
• Supports Market Access and Procurement: Hospitals and government tenders often need evidence of CDSCO compliance. An official MD-26 import license lets your product compete in such procurement processes.

Before applying for MD-26 license, ensure you meet basic eligibility and representation rules. CDSCO expects clear responsibility, technical information, and an Indian liaison if needed. You must be a legal importer or an authorised Indian representative of the foreign manufacturer. Below is the eligibility checklist:

• Applicant is a legally registered importer or authorised local agent
• Device is notified under Medical Device Rules 2017
• Manufacturer has a Free Sale Certificate or equivalent from origin country
• Required technical and safety documents are available
• Importer has IEC or other trade registrations if required

To obtain MD 26 licence having appropriate documents are crucial. Incomplete files are the main reason of delays and queries. Gather all technical, legal, and compliance records. Ensure that manufacturer documents are genuine and updated. Documents include:

• Correctly filled Form MD-26 with true product details
• Free Sale Certificate or Certificate of Marketing Authorization from export country
• Manufacturer’s ISO certificates and quality system documents (if available)
• Detailed product specifications, user manual, and labelling samples
• Test reports and conformity certificates from accredited labs
• Power of Attorney or authorization letter from manufacturer to Indian agent
• Importer’s company registration and IEC (Import Export Code)
• Responsibility for compliance and local contact details
• Any clinical data or safety studies if required by CDSCO

Obtaining MD-26 approval needs accurateness, comprehensive documents, and appropriate follow-ups. Each step ensures your device comply with Indian safety standards. The following is the step by step process:

• Check Device Class & Requirements: Ensure the device class under MDR 2017 and list the technical documents, safety reports, and certificates required. This will help you prepare the right evidence before starting the CDSCO MD-26 certificate filing process.
• Collect Manufacturer Proof & Certificates: Collect accurate manufacturer details, quality system approvals, and a valid Free Sale Certificate. These documents signify the device is legally sold out of the country and follows global safety and performance expectations for import into India.
• Complete Form MD-26 on CDSCO Portal: Fill Form MD-26 online with right device information. Upload all supporting files in clear formats to reduce the chances of errors. Incorrect or missing documents can delay the review and prolong the approval timeline.
• Reply Quickly to CDSCO Queries: CDSCO may ask for extra reports, clarifications, or formatting corrections during assessment. Respond promptly with correct information so your application moves efficiently without unnecessary follow-ups or preventable delays.
• Obtain Licence & Follow Compliance Rules: Once approved, CDSCO issues the import licence. Keep appropriate records, update authorities on changes, and ensure every imported batch matches the specifications and documents submitted in your MD-26 application.

Government fees for CDSCO MD-26 certificate depend on the device class and CDSCO notifications. Fees typically include application charges and testing costs when needed. Extra costs often arise from document certification, translation, lab testing, and professional support. Extra charges vary based on device classification and CDSCO circulars. Always check the current CDSCO fee schedule or consult an expert to get a precise estimate of total costs before submitting Form MD-26.

The processing time for Form MD-26 varies based on the completeness of the dossier and the workload of CDSCO. If all documents are complete and tests are in order, approvals can usually be obtained within 4 to 8 weeks. Delays happen when CDSCO requests more test data, clarification, or local verification. Exporters and importers who prepare a thorough, clear file and respond fast to questions can significantly minimize this timeline.

Is Form MD-27 Required Along With Form MD-26? 

MD-27 is a different form used in the regulatory area. It usually relates to manufacturing licenses for domestic manufacturing sites. For activities involving imports, MD-26 is the relevant form. An importer applying under MD-26 does not need MD-27 unless they also plan to start local manufacturing or contract manufacturing in India. In that case, the Indian manufacturer or contract facility would require the proper manufacturing license or approvals. This may include forms similar to MD-27, depending on state rules and CDSCO requirements.

In short, MD-26 deals with imports. MD-27 and other manufacturing forms cover local production. Importers must focus on MD-26, Free Sale Certificates, and conformity evidence. If you later decide to manufacture locally, then MD-27 or manufacturing licenses will be necessary.

Common Compliance Requirements for MD-26 Applicants

Having a right compliance makes license valid and shipments easy. Maintain documents, report safety problems, and match import shipments to official specs. Some of the common compliances are:

• Keep comprehensive and right technical dossiers for each device.
• Ensure labelling matches permitted MD-26 submissions exactly.
• Maintain batch testing records and certificates for each import.
• Report adverse events and field complaints to CDSCO quickly.
• Keep the Free Sale Certificate and manufacturer credentials recent.
• Update CDSCO in case of any change in materials of any product or manufacturer.
• Ensure Indian approved agent details and POA remain valid.
• Adhere to customs and import regulations, including IEC requirements.

Corpseed is a top consulting firm that helps manufacturers, importers, and startups easily obtain their CDSCO MD-26 License in India. Our team ensures your licensing journey is smooth, fully compliant, and free from delays. We manage your documentation, regulatory checks, and communication with CDSCO so you can focus on building your medical device business with confidence.

• Specialized CDSCO Expertise: Our professionals understand every rule under the Medical Device Rule 2017 and guide you through eligibility, documentation, safety norms, and compliance for MD-26 and related approvals.
• End-to-End Support: From preparing technical files to submitting your CDSCO MD-26 application and obtaining your final loan licence, we handle the full process to save you time and effort.
• Accurate Documentation & Compliance: We ensure your documents meet CDSCO standards to prevent rejections, delays, or compliance gaps during medical device manufacturing and import license assessments.
• Dedicated Follow-Up & Tracking: Our team monitors your application status, communicates with authorities when required, and updates you until your MD-26 licence is issued smoothly and on time.