In the highly regulated Indian market, securing the necessary approvals from the Central Drugs Standard Control Organisation (CDSCO) is not just a formality—it is the indispensable foundation for legal market access, public trust, and sustained business growth. For manufacturers and importers of medical devices, pharmaceuticals, and cosmetics, obtaining a valid CDSCO license or a CDSCO certificate is the non-negotiable gateway to operations in India.
At InstaCertify, we transform this often-complex regulatory journey into a clear, efficient, and guaranteed process. Our expert team specializes in navigating the intricacies of the Drugs and Cosmetics Act, 1940, the Medical Device Rules, 2017, and the Cosmetics Rules, 2020, ensuring your enterprise achieves full CDSCO compliance with speed and accuracy.
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The CDSCO (Central Drugs Standard Control Organisation) functions as India’s premier national regulatory authority, ensuring the safety, efficacy, and quality of vital healthcare and personal care products. Its mission is critical to public health, covering everything from the clinical trial stage to the eventual sale and distribution of a product.
Any company wishing to import, manufacture, or sell the following products in India must successfully complete the CDSCO registration process:
Medical Devices and IVD (In-Vitro Diagnostic) Kits.
Drugs and Pharmaceuticals.
Cosmetics.
Compliance is governed by specific regulations that define the rules for obtaining your CDSCO license:
| Area of Regulation | Governing Legislation | Key Focus |
| Medical Devices | Medical Device Rules (MDR), 2017 | Classification (Class A, B, C, D), QMS, Import License (MD-15), Sale License (MD-42). |
| Cosmetics | Cosmetics Rules, 2020 | Ingredient disclosure, Banned substances, Labeling, Import Registration (COS-2). |
| Drugs | Drugs and Cosmetics Act, 1940 & Rules, 1945 | Manufacturing (GMP), Import Registration, Clinical Trials, New Drug Approval. |
The regulation of medical devices in India has rapidly matured under the Medical Device Rules (MDR), 2017. All medical devices are now regulated as ‘drugs’ under the Act and require mandatory CDSCO registration for manufacturing or importation.
The first, most crucial step in the CDSCO registration process for a device is accurate risk classification. This determines the application form, fees, documentation, and the overall timeline for obtaining the CDSCO license.
| Device Class | Risk Level | Examples | Licensing Authority | Key Form for Import |
| Class A | Low Risk | Thermometers, simple bandages, walking sticks (non-sterile, non-measuring). | State Licensing Authority (SLA) / Central | MD-14 / MD-42 (Sale) |
| Class B | Low-Moderate Risk | Syringes, blood pressure monitors, suction equipment. | SLA / Central | MD-14 / MD-42 (Sale) |
| Class C | Moderate-High Risk | Ventilators, orthopedic implants, Catheters. | Central Licensing Authority (CLA) | MD-14 |
| Class D | High Risk | Heart valves, pacemakers, heart-lung machines, surgical implants. | Central Licensing Authority (CLA) | MD-14 |
The CDSCO system relies on specific forms for different activities:
Form MD-14: The application form used by the Indian Authorized Agent or importer to apply for an Import CDSCO license.
Form MD-15 (The CDSCO License/Certificate): The actual Import CDSCO license granted by the CLA for the import and sale of the medical device in India.
Form MD-41 (Application for Sale/Stock): The application submitted to the State Licensing Authority to obtain the wholesale or retail permission to sell medical devices.
Form MD-42 (Sale/Stock Certificate): The legal CDSCO certificate issued to retailers, wholesalers, and stockists, making it mandatory for all distribution businesses.
Every application, including your application for a CDSCO certificate or CDSCO license, must be submitted through the official CDSCO online portal, known as SUGAM.
SUGAM (Single Unified Gateway for Applicants) is the dedicated digital platform that facilitates transparent and efficient communication between the applicant and the regulatory authority.
SUGAM Registration: Creation of an organizational profile for the manufacturer and the Indian Authorized Agent (IAA) on the CDSCO online system.
Application Filing: Submission of the required form (e.g., MD-14) along with the Device Master File (DMF) and Plant Master File (PMF).
Fee Payment: Payment of prescribed government fees (USD or INR, depending on the application type) via the portal.
Query Resolution: Promptly addressing technical or documentation queries raised by the CDSCO review team.
Inspection (if required): For higher-risk devices (Class C/D manufacturing), a site inspection may be conducted. For foreign importers, the application focuses on dossier review.
Issuance: Upon successful review, the Import CDSCO license is issued in Form MD-15.
Unlike medical devices, cosmetics do not require a manufacturing license for importation, but they do require a mandatory Registration Certificate to ensure safety and quality standards defined by the Cosmetics Rules, 2020.
The importation and sale of any cosmetic product, whether produced by a foreign brand or an Indian manufacturer, must be regulated. Specifically, foreign manufacturers seeking to market their cosmetics in India must appoint an Indian Authorized Agent, who applies for the cosmetic registration certificate.
The process is initiated by filing the application in Form COS-1 on the CDSCO online SUGAM portal, leading to the grant of a registration certificate in Form COS-2.
| Form Name | Purpose | Outcome |
| Form COS-1 | Application for the grant of Registration Certificate for the import of cosmetics. | Initiates the regulatory review process. |
| Form COS-2 (The CDSCO Certificate) | The actual Registration Certificate granted by the Licensing Authority. | Authorizes the import and marketing of the specified brand and its variants in India. |
The CDSCO review focuses heavily on the formulation and labeling, ensuring compliance with the following:
Ingredient Compliance: The product must not contain any ingredient banned or restricted by the CDSCO.
Heavy Metal Declaration: A declaration ensuring heavy metals remain within permissible limits.
Labeling: Labels must comply strictly with the rules, including the mandatory inclusion of the Indian Authorized Agent’s details, import cdsco license number, batch number, and ingredient list.
A perfect dossier is the most significant factor in achieving a fast CDSCO registration timeline. Our team ensures every document is meticulously prepared, authenticated, and submitted via the CDSCO online portal.
| Category | Required Documents for Medical Devices (Import – MD-14) | Required Documents for Cosmetics (Import – COS-1) |
| Legal Authorization | Power of Attorney (Apostilled/Authenticated) in favour of the Indian Agent. | Authorisation Letter (Apostilled/Authenticated) from the manufacturer. |
| Manufacturer Details | ISO 13485:2016 Certificate (Mandatory for all device classes). | Manufacturing License or a declaration that no license is required in the country of origin. |
| Product Documentation | Device Master File (DMF) and Plant Master File (PMF). | Formulations/Ingredient List (with percentage and INCI names). |
| Regulatory Clearance | Free Sale Certificate (FSC) from the country of origin. | Free Sale Certificate (FSC) from the country of origin. |
| Quality & Safety | Essential Principles Checklist (CDSCO prescribed). | Non-Animal Testing Declaration and Heavy Metal Declaration. |
| Application Proof | Online application (SUGAM) printout, Fee receipt, and cover letter. | Online application (COS-1) printout, Fee receipt, and cover letter. |
The cost and time taken to receive your CDSCO license or CDSCO certificate are highly dependent on the product type, risk classification, and manufacturing site location. The following tables detail the typical government fee structure (paid on the CDSCO online portal) and processing times.
The fees are structured based on the risk classification and include a fee for the manufacturing site (Plant Master File – PMF) and a fee for each distinct device family (Device Master File – DMF).
| Device Class | Manufacturing Site Fee (PMF) | Device Family Fee (DMF) |
| Class A (Sterile/Measuring) | $1,000 USD per site | $50 USD per device family |
| Class B | $2,000 USD per site | $1,000 USD per device family |
| Class C | $3,000 USD per site | $1,500 USD per device family |
| Class D | $3,000 USD per site | $1,500 USD per device family |
| Sale License (MD-42) | ₹ 3,000 INR (For the entire premises) | N/A |
Cosmetic fees are based on the manufacturing site and the category of cosmetics (e.g., skin cream, nail polish, hair dye are different categories).
| Application Component | Government Fee |
| Per Manufacturing Site | $500 USD per manufacturing site |
| Per Cosmetic Category | $1,000 USD per cosmetic category |
| Per Variant | $50 USD per variant (e.g., shades, sizes, colors) |
The time taken is based on the statutory review period and the efficiency of the application dossier prepared and submitted through the CDSCO online portal.
| Product Type/Risk Class | Statutory/Estimated CDSCO Review Time | Total Estimated Timeline with InstaCertify Support |
| Cosmetics (COS-2) | Up to 180 working days | 4–6 Months (Highly dependent on query resolution) |
| Medical Devices Class A/B | 90–120 working days | 5–7 Months (After documentation is finalized) |
| Medical Devices Class C/D | 150–180 working days | 7–10 Months (Requires in-depth technical review) |
| MD-42 Sale License | 10–30 days | 2–4 Weeks (State Licensing Authority review) |
Note on Validity: The Import CDSCO license (MD-15) and the Cosmetic CDSCO certificate (COS-2) are typically valid for five years and require renewal before expiry. The MD-42 Sale License is valid perpetually but requires a retention fee every five years.
Achieving your CDSCO registration efficiently requires a partner who understands the regulator’s mindset and the technical demands of the filing process. InstaCertify offers a comprehensive, end-to-end service designed to minimize delays and maximize approval chances.
Classification & Strategy: We accurately classify your device (Class A, B, C, or D) or cosmetic category to determine the exact requirements and the correct application forms (e.g., MD-14, COS-1).
Dossier Perfection: We manage the compilation of the complex Device Master File (DMF), Plant Master File (PMF), and technical documentation, ensuring all legal papers (FSC, ISO, Power of Attorney) are properly Apostilled or Authenticated as required by CDSCO.
CDSCO Online Submission: We handle the entire application filing on the SUGAM CDSCO online portal, ensuring accurate fee payment and digital submission with the appropriate digital signature.
Expert Query Management: Our regulatory specialists act as the direct communication bridge with the CDSCO review officials, rapidly and precisely answering all technical and administrative queries, which significantly reduces the approval timeline for your cdsco certificate.
License/Certificate Issuance: We track the application through final approval, securing your official CDSCO license (Form MD-15/MD-42) or CDSCO certificate (Form COS-2), allowing you to legally market and distribute your products in India.
We've worked with several certification companies in the past, but none compare to Insta Certify Services. Their streamlined testing and certification processes have saved us time and resources. The team goes above and beyond to ensure everything is done correctly, and their equipment is cutting-edge.
We've worked with several certification companies in the past, but none compare to Insta Certify Services. Their streamlined testing and certification processes have saved us time and resources. The team goes above and beyond to ensure everything is done correctly, and their equipment is cutting-edge.
We've worked with several certification companies in the past, but none compare to Insta Certify Services. Their streamlined testing and certification processes have saved us time and resources. The team goes above and beyond to ensure everything is done correctly, and their equipment is cutting-edge.
We've worked with several certification companies in the past, but none compare to Insta Certify Services. Their streamlined testing and certification processes have saved us time and resources. The team goes above and beyond to ensure everything is done correctly, and their equipment is cutting-edge.
CDSCO Registration is the mandatory approval process required for manufacturers, importers, and sellers of drugs, cosmetics, and medical devices in India. It ensures that the products meet the safety, efficacy, and quality standards set by the Drugs and Cosmetics Act.
Who needs it: Drug manufacturers, importers, cosmetic importers, and medical device manufacturers/importers.
Purpose: To legally enter the Indian market and ensure public safety.
The application process is now almost entirely online through the SUGAM Portal (for drugs/cosmetics) or the Online System for Medical Devices.
Register: Create an account on the CDSCO SUGAM Portal.
Document Upload: Upload the required legal and technical documents (see Q10).
Form Submission: Fill out the specific application form (e.g., Form 40 for Registration Certificate, Form MD-X for devices).
Payment: Pay the requisite fee via the Bharat Kosh portal.
Review: The CDSCO officials will review the application and may ask for queries.
Grant: Once approved, the license is generated online.
Fees for CDSCO applications are paid through the Bharat Kosh (Non-Tax Receipt Portal) website.
Visit Bharat Kosh.
Select “Non-Registered Users” (or login if you have an account).
Select Ministry/Department: “Health & Family Welfare”.
Select Purpose: Choose the specific fee type (e.g., “Drug Import License Fee” or “Medical Device Fee”).
Enter the amount and your details.
Pay via Net Banking, Debit/Credit Card, or UPI.
Important: Save the Challan/Receipt; you must upload this on the SUGAM portal as proof of payment.
The cost varies significantly based on the product and activity:
Medical Device Manufacturing:
Class A & B: ₹5,000 (Site) + ₹500 (Per Product).
Class C & D: ₹50,000 (Site) + ₹1,000 (Per Product).
Import License (Drugs): $1000 to $5000 (approx) depending on the number of drugs and manufacturing sites.
Retail/Wholesale Drug License: State-level fees usually range from ₹3,000 to ₹5,000 (Government Challan fee), excluding professional consultant fees.
No. Selling medicines without a valid license is a criminal offense under the Drugs and Cosmetics Act, 1940.
Penalty: It can lead to imprisonment (from 1 year up to life term depending on the severity) and heavy fines.
Retail/Wholesale Drug License: Typically valid for 5 years (renewed thereafter).
Import License (Form 10): Valid for 3 years.
Manufacturing License: Valid for 5 years.
Medical Device License: Often valid in perpetuity, provided you pay a retention fee every 5 years to keep it active.
To start a retail pharmacy (medical shop), you need to apply for a Retail Drug License from your State Drug Control Department (not directly CDSCO, though rules are central). Requirements:
Premises: Minimum 10 sq. meters carpet area.
Pharmacist: You must employ a registered pharmacist (B.Pharm or D.Pharm holder) full-time.
Storage: A refrigerator to store vaccines/insulin.
Application: Apply to your state’s Drug Inspector office with rent agreement, pharmacist’s certificate, and fees.
If you are asking about the Retail Drug License (for a medical shop):
Government Fee: Approx ₹3,000 – ₹4,000.
Total Setup Cost: Opening a shop requires ₹3 Lakh to ₹7 Lakh (Rent, Furniture, Fridge, Stock/Medicines, Computer).
A Free Sale Certificate (FSC) is required to export medical devices/drugs to show they are freely sold in India.
Login to the SUGAM Portal or CDSCO Medical Device Portal.
Navigate to the “Export” or “FSC” section.
Upload your valid Manufacturing License and the list of products.
Upload a Notarized Undertaking stating the products are not banned.
Pay the fee (approx ₹250 per product).
Upon approval, the certificate is issued online.
The documents depend on the license type, but common ones include:
For Manufacturing/Import:
Covering Letter & Authorization Letter.
Power of Attorney (for importers).
Plant Master File (Factory layout, machinery details).
Device Master File (for medical devices).
ISO 13485 Certificate (Quality Management).
Free Sale Certificate from the country of origin (for importers).
For Retail Drug License:
Rent agreement/Ownership proof of premises.
Pharmacist Registration Certificate & Affidavit.
Blueprint/Layout of the shop.
Refrigerator purchase bill.
