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Tue, May 05 2026
Utkarsh Sharma
If you want to bring medical devices into India, like testing machines, surgical tools, implants, or hospital equipment, you need special permission from the government. This permission is called the MD 9 Import License, and it is given by the Central Drugs Standard Control Organisation (CDSCO). Without this license, you are not allowed to legally import and sell these products in the country. It helps make sure that all medical devices coming into India are safe and meet proper quality standards.
In places around Delhi like the AIIMS Delhi area, Dwarka, Rohini, Okhla, Noida, Gurugram, and Faridabad, the demand for medical devices is growing very fast. Because of this, the MD 9 license has become very important for hospitals, distributors, traders, and companies dealing with medical equipment. In this guide, you will learn everything in simple terms, like what documents are needed, how to apply, how much it costs, how long it takes, and how companies like PSR Compliance can help make the process easier and faster without unnecessary delays.
The MD 9 Import License is a government approval that you must have if you want to bring certain medical devices into India from another country. This license is given by the Central Drugs Standard Control Organisation, also known as CDSCO. It mainly applies to Class A and Class B medical devices, which are considered low to moderate risk products. These include items like thermometers, blood pressure monitors, simple diagnostic machines, and some basic hospital equipment. The main purpose of this license is to make sure that the devices being imported are safe to use and meet proper quality standards before they reach patients or hospitals.
This license is required for different types of businesses, not just one. If you are an importer who brings medical devices from other countries, a wholesaler who supplies them in bulk, a manufacturer who sources parts or products from outside India, or a distributor who sells them in the market, you will need this license. In simple words, anyone involved in bringing and selling regulated medical devices in India must have an MD 9 license. It helps the government keep track of what is coming into the country and ensures that only safe and approved products are used in healthcare.
The MD 9 Import License is needed for many types of medical devices that are brought into India from other countries. These products are used in hospitals, clinics, laboratories, and even at home. The main purpose of this license is to make sure that every imported device is safe, tested, and meets quality standards set by the Central Drugs Standard Control Organisation before it reaches patients.
Below is a simple table to help you understand which types of products require an MD 9 license and what they are used for.
In simple terms, if your product is a medical device that falls under Class A or Class B and is regulated by CDSCO, then you will need an MD 9 Import License before you can import and sell it in India.
You need an MD-9 license if you are:
➜ Medical device importer
➜ Distributors/wholesalers
➜ E-commerce sellers supplying medical devices
➜ Hospitals importing machines directly
➜ Diagnostic labs importing equipment
➜ Foreign manufacturers appointing Indian Authorized Agents
In Delhi & NCR, areas with high import volumes include:
Okhla, Naraina, Patel Nagar, Dwarka, Rohini, Noida Sector-63, Gurugram Udyog Vihar, Faridabad Industrial Zone, etc.
Note: If your business deals in imports, MD-9 license is mandatory.
1. Legal approval for importing medical devices
2. Required for customs clearance at ports
3. Increases business credibility
4. Makes your company eligible for government tenders
5. Helps you supply to hospitals, labs & distributors
6. Supports e-commerce onboarding (Amazon, Flipkart, 1mg, etc.)
You must upload the following documents on the CDSCO SUGAM portal:
Company Documents
→ Importer’s address proof
→ Pan card of company
→ GST certificate
→ Constitution documents (MOA, AOA, LLP agreement, Partnership deed)
→ Cover letter
Technical Requirements
→ Free Sale Certificate (FSC) from manufacturing country
→ ISO13485 certificate
→ Device Master File (DMF)
→ Plant Master File (PMF)
→ Undertaking for authorized agent
→ CE Certificate (if applicable)
→ Device description & intended use
Authorized Indian Agent Documents
→ Power of Attorney
→ Agreement between manufacturer & importer
→ Valid wholesale drug license (if required)
PSR Compliance prepares all documents professionally to avoid “Queries/Objection” delays from CDSCO.
Getting an MD 9 Import License may look complicated at first, but if you follow the steps carefully, it becomes much easier. The process is done online through the portal of the Central Drugs Standard Control Organisation, and every step is important to avoid delays or rejection.
First, you need to register your business on the official CDSCO SUGAM portal, which is used for all medical device licensing in India. To begin, create a login ID and password. During registration, you will be required to fill in important details such as your company name, address, type of organization, and authorized contact person details. Once submitted, CDSCO may verify your information before activating your account.
After your account is activated, log in to the portal and choose the appropriate application option for the MD-9 Import License for Class A and Class B medical devices. Selecting the correct category is very important because any mistake at this stage can lead to delays, queries, or even rejection of your application.
In this step, you need to carefully prepare all required documents related to your business and medical devices. These typically include the Free Sale Certificate, ISO certification, Device Master File, Plant Master File, Import Export Code (IEC), GST certificate, and authorization letters. Ensure that all documents are valid, properly signed, and clearly scanned before uploading them on the portal.
Once the documents are uploaded, you must pay the applicable government fee through the online portal. The fee depends on the number and type of medical devices you are applying for. Without successful payment, your application will not move forward for further processing.
After submission, your application will be reviewed by CDSCO officials. They will carefully check all documents and details provided by you. If any discrepancies or missing information are found, they may raise queries on the portal. It is important to respond to these queries within the given timeframe to avoid rejection or delay.
If your application meets all requirements and is approved, CDSCO will issue the MD-9 Import License digitally through the SUGAM portal. You can download the license directly from your account. Once issued, you are legally permitted to import and sell the approved Class A and Class B medical devices in India.
PSR Compliance ensures faster approval with zero errors.
PSR Compliance supports companies across Delhi, Noida, Gurugram, Ghaziabad, Faridabad with:
✔ SUGAM portal registration
✔ Document preparation (DMF, PMF, FSC check)
✔ Classification support
✔ Application filing
✔ Reply to CDSCO objections
✔ End-to-end license support
Our team ensures your MD-9 license is approved quickly without back-and-forth with the department.
An MD-9 license is a mandatory import license issued by CDSCO (Central Drugs Standard Control Organization) for importing Class A and Class B medical devices into India. It ensures that the imported medical devices meet Indian safety and quality standards before being sold in the market.
You can apply for an MD-9 license online through the official CDSCO SUGAM portal. The applicant must register, select the MD-9 import license category, upload required documents, pay the government fee, and submit the application for CDSCO review.
The key documents required for MD-9 license include importer KYC documents, a valid Wholesale Drug License (Form 20B & 21B), ISO 13485 certificate of the manufacturer, Free Sale Certificate, Device Master File, Plant Master File, and an authorization letter (Form 8/Power of Attorney) from the foreign manufacturer.
The MD-9 license approval generally takes around 20 to 30 working days if all documents are correct and complete. However, if CDSCO raises queries or requests clarifications, the timeline may extend by an additional 2–3 weeks.
Yes, the MD-9 import license is valid for a lifetime (perpetual validity). However, the license holder must pay a retention fee every five years to keep the license active and compliant with CDSCO regulations.
Yes, a valid Wholesale Drug License (Form 20B & 21B) is mandatory for obtaining an MD-9 license in India. Without this license, the importer is not eligible to apply for CDSCO medical device import approval.
Yes, a single MD-9 license can include multiple medical devices from the same manufacturer. However, it is recommended to limit the number of devices (usually around 30 per application) to avoid delays and ensure smoother approval.
The MD-9 license fee is generally calculated based on the manufacturing site and number of products. On average, it may include approximately $3,000 per manufacturing site and $1,500 per product, depending on CDSCO guidelines.
If CDSCO finds missing or unclear information in the application, they raise queries on the SUGAM portal. The applicant must respond within the given time frame. Failure to respond properly may lead to delays or rejection of the application.
Yes, applicants can contact the PRO Cell at CDSCO Headquarters in Delhi for regulatory guidance. However, most businesses prefer professional consultants for faster processing, error-free documentation, and smooth approval.
Book your free consultation with our specialists today.