CDSCO Certification in India: Complete Registration & Compliance Guide
“In the healthcare industry, regulatory compliance is not just a legal requirement—it is the foundation of product safety, quality, and market trust.”
The CDSCO Certification in India is a significant regulatory requirement for organisations that import, manufacture, sell, or distribute medical devices and other products falling under India’s healthcare regulatory system.
If you are a foreign manufacturer looking to sell your product in India, an Indian medical device manufacturer, an importer, or a distributor, selecting the right regulatory path from the beginning will help you avoid documentation lapses, application delays, and non-conformity. On this page, we will cover all aspects of CDSCO certification and registration in India, including regulations, CDSCO medical device classification, required documents, the application process, testing, deadlines, compliance, and post-approval actions.
What is CDSCO Certification, and Is It Mandatory in India?
CDSCO Certification refers to a licence or approval issued by the Central Drugs Standard Control Organisation (CDSCO) for products that fall under India's medical device regulations.
This authority operates under the Ministry of Health & Family Welfare, and medical devices in India fall under the ambit of the Drugs & Cosmetics Act, 1940, and the Medical Devices Rules, 2017 (MDR 2017).
It is crucial to understand that there is no single ‘CDSCO Certificate’ that applies to all kinds of products. It totally depends upon the product, its use, risk category, and whether it is being manufactured, imported, sold or distributed in India.
Is CDSCO Registration Mandatory in India?
Yes, obtaining a CDSCO licence is mandatory for all medical devices covered by the Medical Devices Rules, 2017. So, the business must determine whether its product falls within the scope of a medical device and its risk category before proceeding with CDSCO medical device registration, which helps to ensure the product is legally compliant before it is sold in the Indian market.
Which Products Require CDSCO Registration in India?
Keep in mind that not all healthcare or consumer products require the same level of clearance from CDSCO. This will depend on the legal definition of the product in India, its purpose, risk classification, and whether it is made or imported into the country. There are several types of products regulated by CDSCO under various regulatory schemes.
1. Medical Devices
Medical devices are among the primary products regulated by CDSCO under the Medical Device Rules, 2017. Medical devices are classified by risk as Class A, B, C, or D, from low to high. CDSCO maintains classification lists that are subject to revision.
Examples can include: Diagnostic and monitoring equipment, Surgical and medical instruments, Implants, Respiratory devices, Certain medical-device software, In vitro diagnostic (IVD) devices and kits.
2. Drugs and Pharmaceutical Products
CDSCO regulates the import, manufacture, sale, and distribution of drugs in accordance with the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945. Examples of drug categories include Bulk drugs/API and Finished Formulations. For imported drugs, both the product and the manufacturing site may require pre-registration before importation.
3. Cosmetics
The imported cosmetics are controlled in accordance with the Cosmetics Rules, 2020. Cosmetics intended for import into India must generally be registered with the Central Licensing Authority.
Examples may include: Skin-care products, Hair-care products, Make-up products, Cleansing and beautifying products, Other products falling within the statutory definition of cosmetics.
4. Certain Specialised Drugs and Biological Products
Also, CDSCO has regulatory functions for specialised classes such as vaccines, sera, blood and blood products, and IV fluids, with some licensing functions shared with State regulators.
Not sure which category your product falls under?
For medical devices, cosmetics, or drugs, misclassification is one of the most common causes of delays at CDSCO. Our team can confirm your product's regulatory pathway before you proceed.
CDSCO Registration vs License vs Approval: Key Differences Explained
The terms CDSCO Registration, CDSCO Licence, and CDSCO Approval are often used interchangeably, but they do not always refer to the same regulatory action.
| Term | What does it generally mean | Typical application |
|---|---|---|
| CDSCO Registration | The CDSCO registers a product, establishment, or regulatory entity with the authority where the applicable rules require registration. | Depending on the product and regulatory route, registration may apply to certain establishments or products. |
| CDSCO Licence | A licence gives the holder legal authorisation to carry out a specified regulated activity, subject to applicable conditions. | For example, an importer of a medical device applies in Form MD-14 and, if granted, receives the CDSCO import licence in Form MD-15. |
| CDSCO Approval / Permission | The granting of approval or permission means regulatory authorisation for a particular product, procedure, or instance that requires prior assessment or approval under the regulation. | Permission includes permission for clinical investigation, clinical performance testing of particular new IVD products, or permission to import/produce certain new medical devices. |
CDSCO Certification Process: Step-by-Step Registration Guide
The registration/Licensing process varies by product type and classification.
Step 1: Identify the product: Determine whether your product needs to be registered or licensed with CDSCO, and classify it by its nature and category.
Step 2: Document Preparation: Compile all product, manufacturing, quality, technical, and other documents needed for your product.
Step 3: Register for a SUGAM Account: Register yourself and your manufacturing company on the CDSCO Online Portal.
Step 4: Choose the Right Application: Based on the product category, choose the appropriate application from the list of forms available on the portal. For instance, medical device import applications can be done using Form MD-14.
Step 5: Submit Application & Pay Fees: Attach all necessary documents, pay the relevant government fee, and submit your application.
Step 6: CDSCO Examination: The concerned department will conduct a detailed examination of your application. If any document or information is missing, CDSCO may raise a query.
Step 7: Grant of Registration/Licence: CDSCO issues registration/licence/approval after satisfactory review and fulfilment of applicable requirements.
Documents Required for CDSCO Application: Complete Checklist
The documents required for CDSCO Registration/Approval depend on the product type, risk category, and applicant type (importer or product manufacturer). Medical devices are generally accompanied by a set of documents that may be required for their approval, such as:
- Registration and address information of the company.
- Manufacturer Details
- Product Details
- Risk Classification
- Manufacturing Licence/Certificate
- Quality Management Certificate (QMS)
- Free Sale Certificate (FSC)
- Certificate of Conformity
- Test Reports
- Technical Documents
- Label and packaging information.
- Power of Attorney
- Declaration and Undertakings
- Applications were submitted, and the fee was paid.
- Application Form & Fee Receipt.
CDSCO Certification Cost in India (Fee Structure 2026)
How Long Does CDSCO Certification Take? Processing Timeline Explained
The CDSCO process timeline varies depending on the type of application and product. There is no standard timeline for CDSCO-approved drug registrations and licences.
| Licence / Product Type | Application / Licence Form | Indicative Processing Timeline |
|---|---|---|
| Medical Device Import | MD-14 to MD-15 | 270 working days |
| Medical Device Testing | MD-12 to MD-13 | 30 working days |
| Medical Device Clinical Investigation | MD-22 to MD-23 | 90 working days |
| New IVD (In Vitro Diagnostic) Device | MD-28 to MD-29 | 90 working days |
| New Medical Device Without Predicate Device | MD-26 to MD-27 | 120 working days |
| Class C/D Medical Device Manufacturing | MD-7/MD-8 to MD-9/MD-10 | 45 + 60 + 45 working days |
The process timeline for Class C and D manufacturing applications is divided into three stages: 45 days for application review, 60 days for inspection, and 45 days for licensee issuance after the inspection report is received.
CDSCO License Validity and Renewal Process in India
Medical devices issued a medical device license by CDSCO under the Medical Devices Rules, 2017, remain valid until the license is suspended, cancelled, or surrendered. But the licence holder should pay the applicable retention fee for the licence every five years from the date of issue.
How Renewal/Retention is Done?
- The licence is valid: There is no standard renewal for a medical device licence.
- Payment of retention fee: Every five years from the issue of the licence, failure to pay within this time period results in a penalty and cancellation of the licence.
- Required documents to be submitted: Submit the necessary documents as per the applicable rules.
- Continue to comply: The Licensee shall remain compliant with the Medical Devices Rules, 2017.
- No late payments: Failure to pay by the prescribed time will result in a penalty.
Common Reasons for CDSCO Application Delay or Rejection
CDSCO application may be delayed or rejected due to insufficient, incomplete documentation, inconsistency, and non-conformity with regulatory standards as follows:
- Insufficient Documentation: Necessary documents/certificates are not provided.
- Incorrect Application Form: Incorrect application form or approval route chosen for the product.
- Incorrect Product Classification: Medical device/IVD is classified under the incorrect risk category.
- Lack of Technical Information: Technical information, Device Master File, Plant Master File, testing report, and other necessary information are not provided.
- Invalid Certificates: Certificates such as ISO 13485, Free Sale Certificate, or Marketing Authorisation are outdated, incomplete, or not provided in the proper format.
- Non-Response to CDSCO Queries: Failure to respond to queries within the stipulated time limit results in rejection. CDSCO has issued a 2026 notice stating that long-pending applications will be rejected if applicants do not respond to CDSCO’s queries.
If you have a pending or rejected application, ERCS CDSCO Registration agents can help you review the SUGAM file and tell you exactly what the CDSCO needs from you.
CDSCO Registration & Compliance Requirements for Product Manufacturers and Importers
CDSCO regulations are different for Indian medical device manufacturers, importers, and foreign medical device manufacturers. It depends on the product's risk level, its intended use, and whether it is made in India or imported. As per the Medical Devices Rules, 2017, medical devices can be classified into one of four risk classes: A, B, C, or D.
1. Indian Medical Device Manufacturers
First, manufacturers must determine the risk class of the medical device and then apply for a license accordingly. CDSCO categorises Class C and Class D manufacturing licenses as applications done using SUGAM in MD-7/MD-8.
2. Importers of Medical Devices
For a medical-device import licence, the importer shall complete Form MD-14, and the licence will be issued on Form MD-15.
3. Foreign Medical Device Manufacturer
The foreign manufacturer will use the services of the Authorised Indian Agent to import his/her medical device into India. The CDSCO considers the authorised agent to be an individual, firm, or organisation that, under a power of attorney, acts on behalf of the overseas manufacturer to import medical devices into India. The foreign manufacturer will need to provide necessary documentation relating to the product and manufacturing sites.
How ERCS Simplifies Your CDSCO Approval Journey
Getting CDSCO clearance usually involves various regulatory procedures, technical documentation, and interactions with the concerned authority. With proper regulatory assistance, companies can avoid documentation errors and gain a better understanding of the requirements applicable to their products. At ERCS, we facilitate this and make your CDSCO clearance process easier by providing assistance at every stage, from product & regulatory assessment to final approval/licensing.
CDSCO Assistance by ERCS
Product & Regulatory Assessment
Identification of the appropriate CDSCO regulatory pathway and product classification.
Documentation Support
Assistance with preparing and reviewing technical, quality, manufacturing, and regulatory documents.
Application Preparation
Assistance with choosing the appropriate application form and preparing the application.
SUGAM Portal Assistance
Help with applying online through the SUGAM portal and uploading documents.
Query & Clarification Support
Assistance in answering regulatory queries raised during the application process.
Testing & Compliance Assistance
Assistance in identifying appropriate testing and compliance requirements.
Application Tracking
Assistance with monitoring the application status and keeping you informed of any updates.
Post-Approval Compliance
Assistance in meeting CDSCO requirements after getting the license/approval.
Get in touch for a free product classification evaluation and an estimated cost/timeline. [Contact CDSCO consultant in India- ERCS PRIVATE LIMITED TODAY]
Frequently Asked Questions (FAQs)
• Class A - Low Risk (e.g., bandages and examination gloves)
• Class B - Low to moderate risk (e.g., syringes, suction equipment)
• Class C - Moderate to High Risk (e.g., ventilators, bone fixation devices)
• Class D - High Risk (e.g., life-sustaining, life-supporting)
