CDSCO Registration for Medical Devices in India

The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory authority for drugs, medical devices, cosmetics, and clinical trials. It operates under the Directorate General of Health Services (DGHS) within the Ministry of Health and Family Welfare. It regulates the import, manufacture, sale, and distribution of these products to ensure they meet the required standards of safety, quality, and performance.

CDSCO registration refers to the regulatory approval or license required to legally manufacture, import, or market regulated healthcare products in India. The type of approval depends on the product category and its risk classification:

• Medical devices are regulated under the Medical Devices Rules, 2017 (MDR 2017).
• Drugs and cosmetics are regulated under the Drugs and Cosmetics Act, 1940, and the rules framed under it.

Manufacturers, importers, and Indian Authorized Agents submit their applications through the CDSCO SUGAM portal (cdscoonline.gov.in). They must obtain the required approval before manufacturing, importing, or marketing regulated products in India.

Regulatory References for CDSCO

The following regulatory bodies govern the approval, regulation, and compliance of medical devices in India:

• Medical Devices Rules, 2017 (MDR 2017): The primary regulatory framework governing medical device classification, licensing procedures, and applicable fees under the Second Schedule, along with relevant application forms.
• Drugs and Cosmetics Act, 1940: The parent legislation governing drugs, cosmetics, and regulated medical devices under CDSCO in India.
• Medical Devices (Amendment) Rules: Including the Sixth Amendment Rules, 2022 (G.S.R. 777(E)), which introduced key changes such as an exemption for Class A non-sterile, non-measuring devices.
• Central Drugs Standard Control Organization (CDSCO): The national regulatory authority responsible for approval, regulation, and enforcement of drugs and medical devices in India.
  CDSCO SUGAM Portal: The official online platform used for application submission, document upload, fee payment, tracking, and licence issuance.
• Ministry of Health and Family Welfare (MoHFW): The central government ministry under which CDSCO functions and which issues regulatory amendments and notifications.

Major benefits of CDSCO registration include:

• Ensures legal compliance: It allows you to legally manufacture, import, distribute, and sell regulated drugs, medical devices, and cosmetics in India.
• Provides access to the Indian market: Registration is mandatory for introducing regulated healthcare products into India and expanding your business.
• Protects public health: CDSCO evaluates regulated products against prescribed safety, quality, and performance standards before they reach patients and consumers.
• Maintains uniform regulatory standards: CDSCO and State Drug Control Authorities enforce consistent regulatory requirements across India, creating a predictable compliance framework for businesses.
• Builds trust and credibility: CDSCO approval reassures hospitals, healthcare professionals, distributors, and consumers that your product meets Indian regulatory standards.
• Supports government and institutional procurement: Many government tenders and healthcare institutions require suppliers to hold valid CDSCO approvals.
• Facilitates smoother imports: CDSCO licenses help simplify customs clearance and reduce delays for imported medical devices.
• Creates a competitive advantage: Regulatory compliance makes your products more attractive to distributors, procurement agencies, and healthcare providers.
• Enhances export credibility: Compliance with Indian regulatory standards can strengthen your reputation in international markets and support expansion into other regulated jurisdictions.
• Reduces regulatory risks: Maintaining CDSCO compliance helps avoid penalties, product seizures, license suspension, recalls, and other enforcement actions.

CDSCO regulates healthcare products to ensure their safety, quality, and effectiveness before they enter the Indian market. These products include:

Medical devices and IVDs form one of the most structured and heavily regulated categories under CDSCO, with detailed classification, licensing forms, and compliance requirements. As a result, medical device registration and approval processes form a major part of CDSCO regulatory applications in India.

CDSCO issues different licenses based on product type, activity, and risk classification under the Drugs and Cosmetics Act, 1940, the Medical Devices Rules, 2017, and the Cosmetics Rules, 2020. These include:

1. Drug Manufacturing License

This license is required to manufacture drugs and pharmaceuticals in India. It ensures compliance with GMP standards, safety norms, and quality control requirements under the Drugs and Cosmetics Act, 1940.

• Purpose: Manufacturing of drugs and formulations in India
• Application forms: Form 24 (application) → Form 25 (license) for non-loan manufacturing; Form 24A → Form 25A for loan licenses
• Authority: State Licensing Authority (with CDSCO oversight for new drugs)
• Key requirement: GMP compliance (Schedule M) and a qualified quality control system

2. Import License

This license is required to import drugs, medical devices, or cosmetics into India. It ensures only safe and compliant products enter the market.

• Purpose: Import of regulated healthcare products
• Medical device forms: MD-14 (application) + MD-15 (license)
• Cosmetics import: COS-1 under Cosmetics Rules, 2020
• Key requirement: Product must meet Indian regulatory standards

3. Drug Registration Certificate

This certificate is required for foreign manufacturers before their products can be sold or imported in India.

• Purpose: Legal marketing of imported drugs
• Application form: Form 40
• Approval form: Form 41
• Issued after: CDSCO product evaluation and review

4. Medical Device Registration and License

Medical devices are classified as Class A, B, C, or D based on risk level. Approval depends on this classification:

• Risk-based classification: A (low risk) to D (high risk)
• Manufacturing license:
  • Class A & B → MD-3 (application) + MD-5 (license), by State Licensing Authority
  • Class C & D → MD-7 (application) + MD-9 (license), by Central Licensing Authority
• Loan license:
  • Class A & B → MD-4 (application) + MD-6 (license)
  • Class C & D → MD-8 (application) + MD-10 (license)
• Import/testing: MD-16 (application) + MD-17 (license)

5. Clinical Trial Approval

This approval is required before conducting clinical trials in India. It ensures ethical and scientific compliance.

• Purpose: Human trials for drugs or medical devices
• Application form: CT-06
• Platform: SUGAM portal
• Key focus: Safety, ethics, and study validity

6. Test License

This license allows limited import or manufacture before full approval.

• Purpose: Testing, analysis, or research use
• Form used: Form 29
• Scope: Limited quantity only
• Use case: Pre-approval evaluation

7. Wholesale and Distribution License

This license is required to sell, store, or distribute drugs and medical devices in India.

• Purpose: Legal sale and distribution
• Device forms: MD-41 (application) + MD-42 (license)
• Key requirement: Proper storage and supply chain compliance

8. Good Manufacturing Practice (GMP) Certification

GMP certification ensures manufacturing quality and safety standards are maintained.

• Standard followed: Schedule M
• Focus areas: Hygiene, infrastructure, documentation, quality systems
• Outcome: Consistent product safety and effectiveness

9. Certificate of Pharmaceutical Product (COPP)

This certificate is required for exporting medicines from India.

• Purpose: Export approval for pharmaceuticals
• Requirement: Product must be approved in India
• Condition: Manufacturing must follow GMP standards
• Use: International regulatory acceptance

Under the Medical Devices Rules, 2017, medical devices are grouped into four risk-based classes based on invasiveness, duration of body contact, and life-support function:

1. Class A (Low Risk)

These are simple, non-invasive devices with minimal risk to patients or users. They follow the least complex regulatory pathway and, in many cases, involve lighter scrutiny.

• Examples: Thermometers, surgical dressings, alcohol swabs
• Authority: State Licensing Authority
• Key detail: Non-sterile and non-measuring Class A devices generally follow a simplified approval route with lighter compliance requirements

Important 2026 Update: Class A Non-Sterile and Non-Measuring (NSNM) medical devices are exempt from mandatory licensing. Manufacturers and importers only need to self-certify compliance and obtain a registration number through the CDSCO portal. They do not need an import or manufacturing license, Device Master File (DMF), or Plant Master File (PMF).

2. Class B (Low to Moderate Risk)

These devices carry a slightly higher risk than Class A but are still considered relatively low risk.

• Examples: Hypodermic needles, suction equipment, blood pressure monitors
• Authority: State Licensing Authority
• Key detail: Requires basic regulatory review and compliance with essential safety and quality standards

3. Class C (Moderate to High Risk)

These devices are used in critical medical situations and require stricter regulatory control due to higher patient risk.

• Examples: Ventilators, infusion pumps, orthopedic implants
• Authority: Central Licensing Authority
• Key detail: Requires detailed technical documentation, performance data, and safety evaluation

4. Class D (High Risk)

These are life-supporting or life-sustaining devices where failure can result in serious harm or death.

• Examples: Pacemakers, heart valves, implantable devices, dialysis machines
• Authority: Central Licensing Authority
• Key detail: Subject to the most stringent review, including extensive clinical evidence and risk assessment

This classification determines the applicable regulatory pathway. It also decides the required forms, licensing authority, documentation, fees, and approval timelines.

CDSCO registration applies to any entity involved in manufacturing, importing, distributing, testing, or marketing regulated healthcare products in India. These include:

CDSCO requires a structured set of technical, legal, and quality documents to assess the safety, performance, and compliance of a medical device before approval. These include:

• Device Master File (DMF): Provides complete product-specific technical details, including design, specifications, intended use, materials, and risk classification.
• Plant Master File (PMF): Covers details of the manufacturing facility, infrastructure, production processes, quality systems, and compliance controls.
• Free Sale Certificate (FSC): Issued by the regulatory authority of the country of origin or a recognised reference market (such as the USA, EU, UK, Canada, Japan, or Australia). It confirms that the product is freely sold in that country.
• ISO 13485 Certificate: Demonstrates that the manufacturer follows a compliant Quality Management System (QMS) for medical devices.
• Power of Attorney (PoA): Authorizes the Indian Authorized Agent to act on behalf of the foreign manufacturer. It must be notarised and apostilled or properly authenticated.
• Details of Indian Authorized Agent (IAA): include a valid wholesale/manufacturing license (such as Form 20B/21B or equivalent), along with business registration and contact details.
• Test and Performance Reports: Include safety, performance, and validation test reports from recognised or accredited laboratories.
• Labelling and Packaging Details: Must comply with MDR 2017 labelling requirements, including manufacturer details, device name, batch/lot number, manufacturing and expiry dates, and usage instructions.
• Quality Management System (QMS) Documents: Include SOPs, validation records, process controls, and quality assurance procedures followed by the manufacturer.
• Clinical Data (if applicable): May be required for Class C and D devices or new/high-risk devices. Includes clinical evaluation reports, study data, or published evidence supporting safety and performance.
• Biocompatibility and Sterilisation Reports (for higher-risk devices): Required for implantable or sterile devices to confirm material safety and sterilization effectiveness.
• Regulatory Approval History (if available): Previous approvals or registrations in other countries may be required as supporting evidence for evaluation.

A complete and consistent dossier is critical for CDSCO approval, as incomplete documentation often leads to queries, delays, or rejection.

The medical device registration procedure is fully online and is carried out through the CDSCO SUGAM portal under the Medical Devices Rules, 2017. The exact pathway depends on the device classification (Class A, B, C, or D) and whether it is being manufactured or imported. Here’s how it works:

Step 1: Classify Your Device

• Determine the risk class (A, B, C, or D) using the CDSCO classification system.
• Classification depends on invasiveness, usage, and patient risk.

This decides the applicable forms, authority, fees, and approval route.

Step 2: Appoint an Indian Authorized Agent – For Foreign Manufacturers

• Foreign manufacturers must appoint an Indian Authorized Agent (IAA).
• The IAA must hold a valid license and act as the legal representative in India.
• The agent handles all communication with CDSCO and compliance obligations.

Step 3: Create an Account on SUGAM Portal

• Register on the CDSCO SUGAM portal for online filing.
• The portal is used for application submission, fee payment, query response, and license download.
• Ensure correct entity details and business information during registration.

Step 4: Prepare Regulatory Documentation

• Compile the complete technical and regulatory dossier.
• Key documents include:
  • Device Master File (DMF)
  • Plant Master File (PMF)
  • ISO 13485 certification
  • Free Sale Certificate (FSC)
  • Performance and safety test reports

Ensure documents are consistent and comply with CDSCO format requirements.

Step 5: File Application and Pay Fees

• Submit the relevant application form (e.g., MD-14 for import, MD-3/MD-7 for manufacture).
• Upload all supporting documents on the SUGAM portal.
• Pay applicable government fees online.

Step 6: CDSCO Review and Query Handling

• CDSCO reviews the application for completeness and compliance.
• Queries may be raised for clarification or additional documents.
• Timely and complete responses are required to avoid delays in processing.

Step 7: Inspection (If Applicable)

• For Class C and D devices, authorities may inspect the manufacturing site.
• Inspection focuses on GMP compliance, infrastructure, and quality systems.
• Observations must be resolved before approval is granted.

Step 8: Grant of License

• Once satisfied, CDSCO issues the final approval (e.g., MD-15 for an import license).
• The device can then be legally manufactured, imported, and marketed in India.
• Ongoing compliance must be maintained to keep the license valid.

The CDSCO approval timeline varies based on device risk class, documentation quality, and whether the application is for import or manufacturing under the Medical Devices Rules, 2017. Below is the typical stage-wise timeline:

Timelines may vary depending on product complexity, regulatory queries, inspection requirements, and completeness of the application.

CDSCO fees are prescribed under the Second Schedule of the Medical Devices Rules, 2017, and are paid online through the SUGAM portal. Import fees are officially specified in US dollars and paid in the rupee equivalent. The figures below are approximate and depend on the prevailing exchange rate.

Note: Import fees and inspection fees are set in US dollars under MDR 2017 and are payable in the rupee equivalent at the current exchange rate. Manufacturing license fees are fixed in rupees.

CDSCO licenses are not permanently “renewed” in the traditional sense anymore. The system now works on a perpetual validity model, supported by periodic retention payments and continuous compliance. This ensures that only safe and compliant products remain in the Indian market.

Validity of CDSCO License

CDSCO licenses, including import licenses (Form MD-15) and manufacturing licenses, have perpetual validity. However, applicants must continue to comply with the Medical Devices Rules, 2017, to keep the license valid. The license remains active only if the applicant:

• Maintains full compliance with applicable regulatory requirements.
• Continues to meet quality and safety standards.
• Pays the required retention fee every 5 years within the prescribed timeline.

If the applicant fails to comply, CDSCO may suspend or cancel the license.

CDSCO License Renewal

Instead of renewal, the applicant must now follow a retention-based system. The applicant must pay a retention fee to keep the license active for the next 5-year block. The process includes the following steps:

1. Log in to the SUGAM portal and access the existing license.
2. Pay the retention fee before the completion of every 5 years.
3. Ensure the retention fee equals the original license fee.
4. Pay applicable late fees if the applicant misses the due date.
5. Update CDSCO with any additional product or license changes, if applicable.
6. Maintain continuous compliance with MDR 2017 throughout the validity period.

If the applicant fails to pay the retention fee on time, CDSCO may impose late fees per month of delay. Continued non-payment may result in suspension or deactivation of the license.

CDSCO introduced several regulatory updates in 2026 to simplify licensing, strengthen compliance, and improve India's medical device regulatory framework. Key developments include:

• Draft amendments to the Medical Devices Rules, 2017: In June 2026, the Ministry of Health and Family Welfare published draft amendments to simplify the licensing process. The proposal aims to reduce manufacturing license timelines while maintaining safety and quality standards.
• Draft revision of medical device testing fees: In April 2026, CDSCO issued Draft Notification G.S.R. 269(E). The draft proposes changes to the medical device testing fee structure under the Medical Devices Rules, 2017.
• Revised sampling guidelines: In May 2026, CDSCO issued revised guidelines for sampling drugs, cosmetics, and medical devices. The new guidelines help Central and State Drug Inspectors conduct inspections more consistently and strengthen quality surveillance.
• Additional Medical Device Testing Officers notified: In February 2026, CDSCO notified additional Medical Device Testing Officers (MDTOs) for designated laboratories. The move strengthens medical device testing and regulatory oversight.

Businesses often face several challenges during the CDSCO registration process. However, proper planning and compliance can help overcome them. Here are some common challenges and their solutions:

• Incorrect device classification: Misclassifying a medical device can result in the wrong application or license category. Classify the device according to the Medical Devices Rules, 2017, before applying.
• Incomplete documentation: Missing or inaccurate technical documents, quality certificates, or declarations can delay approval. Prepare and verify all required documents before submission.
• Errors in the application: Incorrect information on the CDSCO portal may lead to deficiency letters or rejection. Review the application carefully before filing.
• Delays in responding to CDSCO queries: CDSCO may seek additional information or clarifications during the review process. Respond promptly with complete and accurate documents to avoid delays.
• Meeting quality and regulatory requirements: Manufacturers must maintain applicable quality standards and regulatory compliance throughout the product lifecycle. Implement a robust Quality Management System (QMS), such as ISO 13485, where applicable.
• Keeping up with regulatory changes: CDSCO regularly updates its rules, notifications, and guidance documents. Monitor regulatory updates to ensure continued compliance.
• Complying with foreign manufacturer requirements: Overseas manufacturers must appoint an Indian Authorized Agent (IAA) and submit properly legalized or apostilled documents wherever required.
• Maintaining post-approval compliance: Registration is not a one-time requirement. Renew licenses on time, maintain regulatory records, report significant changes, and comply with post-market surveillance obligations.