CDSCO site registration for foreign manufacturing sites is a mandatory procedure that allows international manufacturers to legally sell medical devices or drugs in India. Before any product reaches Indian customers, it should be approved by the Central Drug Standards Control Organization, which includes registering the foreign manufacturing facility. This ensures that all imported products meet Indian safety, quality, and regulatory standards. In this comprehensive guide, we walk you through the CDSCO site registration process, requirements, and how you can quickly get approval to sell your medical products in India.
What is the CDSCO Site Registration For Foreign Manufacturing Sites?
The Central Drugs Standard Control Organization of India requires overseas manufacturing sites to register as CDSCO sites. It permits international businesses to lawfully export medications or medical equipment to India. Before any product is imported, the foreign production facility must be registered with the Central Drugs Standard Control Organization (CDSCO) to ensure adherence to Indian safety and quality standards. Without this registration, which is carried out by an authorized Indian representative, the product cannot be marketed legally in the Indian market.
Note: The application must be submitted by an authorized Indian agent (IAA)—foreign manufacturers cannot apply directly.
Is CDSCO Site Registration Mandatory For Foreign Manufacturers?
CDSCO site registration is mandatory for foreign manufacturers to make sure that the medical devices or drugs they export to India are safe, effective, and meet Indian quality standards. It helps CDSCO keep a product in India. Verify the product’s manufacturing location and method to make sure that only reputable and authorized goods are permitted to enter the Indian market. It is illegal for foreign businesses to sell their goods without this registration. Don’t risk delays, make sure your registration is done right from the start. Talk to our experts today.
Which Products Require CDSCO Site Registration For a Foreign Manufacturing Site?
CDSCO site registration is required for medical devices, in vitro diagnostics devices, and certain drugs that are manufactured outside India and intended to be imported and sold in the Indian market. Products covered include CDSCO regulations on orthopedic implants, stents, surgical instruments, diagnostic kits, and pharmaceutical medications. You should register your manufacturing location if your items are on the CDSCO-notified list.
Who Can Apply for CDSCO Site Registration on Behalf Of A Foreign Manufacturing Site?
A foreign manufacturer cannot apply directly for CDSCO site registration. Instead, they must appoint an authorized Indian agent who is based in India and registered with CDSCO. This agent acts as a legal representative and takes responsibility for applying, managing communication with CDSCO, and ensuring all Indian regulations are followed.
What Documents Are Required For CDSCO Site Registration For Foreign Manufacturing Sites?
If you want to apply for CDSCO site registration for foreign manufacturing sites then you must carry all these documents that we have mentioned below:
- Covering Letter
- Duly Filled Application Form
- Power of Attorney
- Site Master File
- Manufacturing Licenses
- Free Sale Certificate
- List of Products To Be Imported
- Establishment Registration Certificate
- Quality Certificate
- Plant Master File
- Undertaking
- Copy of Importer License
What Is The Procedure For CDSCO Site Registration For Foreign Manufacturing Sites?
To sell medical devices, cosmetics, or drugs in India, foreign manufacturers must register their manufacturing site with the Central Drug Standard Control Organisation. This procedure ensures that the site meets Indian safety, quality, and compliance standards. Check the easy procedure to get the CDSCO site registration for foreign companies manufacturing sites done simply:
Step 1 – Prepare the Power of Attorney
- Issued by the foreign manufacturer
- Notarized and legalized in the country of origin
Step 2 – Compile the Site Master File
- Plant layout
- GMP Practices
- Quality Assurance Systems
- Equipment and Sanitization Protocols
- Manufacturing area, personnel, HVAC, utilities
Step 3 – Fill Out & Submit Form 40
- Should be submitted by the Indian authorised Agent
- Includes applicant’s details, manufacturing info, list of products, and manufacturing site address.
Step 4 – Upload All Required Documents
- Cover Letter
- Power of Attorney
Step 5 – Pay the Government Fee
- Site registration fee
- Product registration fee
Step 6 – Application Review
- CDSCO official review documents for accuracy and completeness
- If needed, they may raise queries or clarification requests via the SUGAM portal
- A physical inspection of the manufacturing site may be requested in rare cases.
Step 7 – Grant of Site Registration Certificate
- A registration certificate in Form 41 is issued for the foreign manufacturing site.
- The certificate is valid for 3 years.
Note – You can check the important documents in the next answer, where we have mentioned the most necessary documents.
What is the Timeline for Getting CDSCO Site Registration For Foreign Manufacturing Units?
The timeline for getting CDSCO site registration for foreign manufacturing units is a bit complicated. Check the box to understand it easily.
| S.No. | Step | Estimated Time |
|---|---|---|
| 1. | Documents Collection & Preparation | 2 – 4 Weeks |
| 2. | Power of Attorney Legalization | 1- 2 Weeks |
| 3. | SUGAM Portal Registration & Form 40 Submission | 1 Week |
| 4. | CDSCO Review of Application | 4 to 6 Months |
| 5. | Clarification Handling | 1 – 2 months |
| 6. | Final Approval & Grant of Form 41 | 1 – 2 Weeks after review |
How To Renew CDSCO Site Registration for Foreign Manufacturing Sites?
To renew your CDSCO site registration for foreign manufacturing sites, follow these points:
- Start by Process Early
- Prepare Updated Documents
- Submit Form 40 Again
- Pay the Prescribed Fee
- CDSCP Review
- Get Updated Form 41
Why Choose ELT Corporate for CDSCO Site Registration for Foreign Manufacturing Sites?
Selecting ELT Corporate for your CDSCO site registration means you get expert support, faster processing, and peace of mind. It is the best Regulatory Consultancy in India, so you can choose it without any second thought.
- Expertise in Regulatory Approval
- End-to-End Support
- Accurate Documentation
- Post Registration Support
- Assistance With an Indian Authorized Agent
Ready to simplify your CDSCO site registration
Start Your Registration Process with Us! For any queries, feel free to call us at 9899997002 or email us at info@medicaldeviceregistration.com
Is CDSCO Site Registration Mandatory For All Foreign Medical Device Manufacturers?
Yes, CDSCO site registration is mandatory for all foreign medical device manufacturers before selling in India.
Can a Foreign Company Apply Directly for CDSCO Site Registration?
No, a foreign company should appoint an Indian authorized agent (IAA) to directly apply for CDSCO site registration.
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