When a business manufactures or imports several regulated products in India, one common question is: Can one CDSCO license cover multiple products?
The answer is sometimes yes, but it depends on the type of product, its classification, manufacturing site, brand, and the type of approval required.
For medical devices, the regulatory framework allows additional products to be added to an existing licence through an endorsement process, subject to applicable requirements and fees. CDSCO also has specific provisions for products and manufacturing sites under the Medical Devices Rules, 2017.
For cosmetics, the process is different. Imported cosmetics require registration with the Central Licensing Authority, while cosmetics manufactured in India are licensed by the respective State Licensing Authorities.
This article explains when multiple products can be covered and what businesses should check before applying.
What Is a CDSCO License?
The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory authority for various drugs, medical devices and cosmetics-related regulatory activities.
The type of approval depends on the product.
For example:
Medical devices may require an import or manufacturing licence.
Imported cosmetics require product registration before import.
Cosmetics manufactured in India are regulated through State Licensing Authorities.
The applicable requirements can change based on product category and risk classification.
For medical devices, CDSCO uses a risk-based classification system:
Class A: Low risk
Class B: Low to moderate risk
Class C: Moderate to high risk
Class D: High risk
Therefore, a company should not assume that one approval automatically covers every product it sells.
Can One CDSCO License Cover Multiple Products?
Yes, in certain cases, one licence can cover multiple products. However, the products generally need to meet the applicable regulatory conditions and be properly included in the licence or endorsed through the prescribed process.
For medical devices, CDSCO's FAQ specifically states that additional medical devices can be added to an existing licence through an endorsement application, along with the required documents and fees.
This means a company may not always need to start a completely new licence application for every additional medical device.
However, the regulatory requirements should be checked for each product.
Example
Suppose a company already has permission to import a particular medical device.
Later, it wants to import another medical device from the same or another manufacturing site.
The company may need to apply for the addition or endorsement of the new product and provide the required information and documents.
The new product does not simply become legal for import because another product is already present on the licence.
Multiple Products Under a Medical Device Import Licence
A CDSCO Medical Device import licence is generally issued based on the products, manufacturers, sites, and other information submitted in the application.
CDSCO's medical device FAQ explains that additional products can be added to an existing licence through an endorsement application with the required documents and fees.
CDSCO also provides guidance regarding additional manufacturing sites and products. Its FAQ notes that when an additional product is imported from a different manufacturing site, applicable fees for the additional site and product are required.
Therefore, businesses should consider:
Product name
Device classification
Intended use
Manufacturer
Manufacturing site
Brand
Product specifications
Applicable standards
Required documents
Applicable government fees
What if the same device has different brands?
This is important for businesses working with private-label products.
CDSCO's FAQ states that a separate fee is required for each applied brand of a medical device under the Second Schedule of the Medical Devices Rules, 2017.
So, having similar products does not necessarily mean that every brand can be treated as one product.
What Is CDSCO Medical Device Registration?
The term CDSCO Medical device registration is commonly used by businesses looking for regulatory approval for medical devices in India.
However, businesses should distinguish between registration and licensing requirements.
CDSCO states that, following the implementation of the applicable notification, medical devices are generally under the licensing regime, except for Class A non-sterile and non-measuring medical devices that are exempted from the licensing regime under the relevant provisions.
For importing medical devices, an applicant applies in Form MD-14 through the SUGAM portal for grant of an import licence in Form MD-15.
Therefore, before starting a CDSCO Registration Online application, it is important to identify the exact product and applicable regulatory route.
Can One CDSCO Cosmetic License Cover Multiple Cosmetics?
Cosmetics follow a different regulatory system.
According to CDSCO, manufacturing licences for cosmetics in India are issued by the respective State Licensing Authorities, not directly by CDSCO. Import of cosmetics, on the other hand, is regulated through registration by the Central Licensing Authority.
This distinction is important when discussing a CDSCO cosmetic manufacturing license.
For imported cosmetics, CDSCO states that the product must be registered along with details such as:
Pack size
Variants
Manufacturing premises
Product information
before the cosmetic is imported into India.
So, businesses should not treat cosmetic manufacturing approval and cosmetic import registration as the same approval.
How Many Cosmetic Products Can Be Included?
For cosmetic import applications, CDSCO introduced a limit of 50 products per single online application from August 16, 2024. Multiple applications can be submitted when more products need to be processed.
This is a useful point for companies handling large cosmetic portfolios.
For example, if a company has 120 cosmetic products for import:
First application: up to 50 products
Second application: up to 50 products
Third application: remaining products
The exact regulatory treatment can depend on the product details and applicable requirements.
Does One Licence Automatically Cover New Products?
No.
This is one of the most important points businesses should understand.
If a company receives approval for Product A, it should not assume that Product B is automatically covered.
For an additional medical device, the company may need to submit an endorsement application with the prescribed documents and fees.
For cosmetics, each product and its relevant details must be properly covered under the applicable registration or licensing framework.
Therefore, before selling, importing or manufacturing a new product, businesses should check whether it is already covered by their existing approval.
What Factors Decide Whether Multiple Products Can Be Covered?
Several factors can affect the answer.
1. Product Category
A medical device, cosmetic, drug or other regulated product may follow a different approval process.
2. Risk Classification
Medical devices are classified into Classes A, B, C and D based on risk. The applicable regulatory requirements can differ according to classification.
3. Manufacturer
The manufacturer listed in the regulatory documents is important.
Changing the manufacturer may require additional regulatory action.
4. Manufacturing Site
The manufacturing location is also relevant.
If products come from different manufacturing sites, additional site-related requirements may apply.
5. Brand
Different brands can result in additional requirements and fees. CDSCO specifically notes separate fees for different brands of a medical device.
6. Product Specifications
Two products that look similar may still have different specifications, intended uses or regulatory classifications.
7. Import or Manufacturing Activity
Importing a product and manufacturing a product can involve different licences and authorities.
How to Apply for CDSCO Approval Online?
Businesses looking for CDSCO Registration Online should first identify the exact regulatory requirement.
A general process may include:
Step 1: Identify the Product
Determine whether the product is a medical device, cosmetic or another regulated category.
Step 2: Check Classification
For medical devices, determine the applicable risk class.
Step 3: Identify the Regulatory Route
Check whether the product requires an import licence, manufacturing licence, registration or another approval.
Step 4: Prepare Documents
Documents may include product information, manufacturer details, technical documents, labels, certificates and other applicable records.
Step 5: Submit the Application
The relevant application can be submitted through the applicable CDSCO online system, such as the SUGAM portal.
Step 6: Regulatory Review
The authority reviews the application and supporting documents.
Step 7: Approval or Further Clarification
If the requirements are satisfied, the applicable approval may be issued. If clarification or additional documents are required, the applicant may need to respond.
Common Mistakes Businesses Should Avoid
When applying for multiple products, businesses should avoid these common mistakes:
Assuming Similar Products Need No Separate Action
Two products may look similar but have different regulatory requirements.
Not Checking Product Classification
Medical device classification can affect the applicable approval process.
Ignoring Brand Differences
Different brands may create additional regulatory and fee requirements.
Not Updating the Licence
A newly launched product should be checked against the existing licence before import or manufacture.
Confusing Registration With Licensing
The terms "registration" and "licence" are often used interchangeably in the market, but they can represent different regulatory processes.
Using the Wrong Authority
For example, CDSCO states that cosmetic manufacturing licences in India are issued by State Licensing Authorities, while cosmetic imports are regulated through the Central Licensing Authority.
How Corpbiz Can Help
Managing several regulated products can become difficult when each product has different documentation and regulatory requirements.
Corpbiz helps businesses understand the applicable regulatory route and prepare their applications based on the product category.
Our support can include:
Medical device regulatory guidance
CDSCO Medical device registration support
CDSCO Medical Device import license assistance
Product classification guidance
Documentation support
Application preparation
Additional product endorsement support
Cosmetic import registration assistance
Regulatory compliance support
Before applying, businesses should review their product portfolio and determine which products can be covered under an existing approval and which may require additional action.
FAQs
1. Can one CDSCO licence cover multiple medical devices?
Yes, in applicable cases, multiple medical devices can be covered under an existing licence. Additional products may require an endorsement application, supporting documents, and applicable fees.
2. Can I add a new medical device to an existing import licence?
Yes. CDSCO's FAQ provides for an endorsement application for adding medical devices as additional products to an existing licence.
3. Is a CDSCO Medical Device import licence required for all medical devices?
Medical device requirements depend on the applicable regulatory framework and classification. CDSCO states that medical devices are generally under the licensing regime, subject to the specified exception for Class A non-sterile and non-measuring devices.
4. Is CDSCO Medical device registration the same as a medical device import licence?
Not necessarily. Businesses should identify the specific approval applicable to their device and activity. For medical device imports, CDSCO provides for an import licence application in MD-14 and grant of licence in MD-15.
5. Does CDSCO issue a cosmetic manufacturing licence in India?
No. CDSCO's FAQ states that cosmetic manufacturing licences are issued by the respective State Licensing Authorities.
6. What is a CDSCO cosmetic manufacturing licence?
The term is commonly used to describe approval for manufacturing cosmetics, but the manufacturing licence in India is issued by the applicable State Licensing Authority rather than CDSCO.
7. Can multiple cosmetics be registered for import?
Yes. Multiple cosmetic products can be included in the applicable registration process, subject to the rules and application requirements. CDSCO currently limits a single online application to a maximum of 50 products, with multiple applications permitted.
8. Can different brands of the same medical device be covered together?
Different brands should not automatically be treated as one product. CDSCO states that a separate fee is required for each applied brand of a medical device.
9. Can products from different manufacturing sites be included?
It may be possible, but additional site-related requirements and fees can apply. CDSCO's guidance specifically addresses additional manufacturing sites for imported medical devices.
10. How can I apply for CDSCO Registration Online?
The appropriate online process depends on the product and activity. Medical device applications are handled through the CDSCO online system, while cosmetic import registration is also processed through the CDSCO online system. Businesses should first identify the correct form and regulatory category before submitting an application.
Conclusion
One CDSCO licence may cover multiple products, but it does not automatically cover every product a business manufactures or imports.
For medical devices, additional products may be added to an existing licence through the prescribed endorsement process, subject to applicable documents, fees and regulatory conditions.
For cosmetics, businesses need to understand the difference between manufacturing licences issued by State Licensing Authorities and registration for imported cosmetics handled by the Central Licensing Authority.
Before launching a new product, always check its classification, manufacturer, manufacturing site, brand, intended use, and applicable regulatory requirements.
Author Profile
Author: Atul Shukla
Legal Advisor | Corpbiz Advisors
Atul Shukla is a legal advisor associated with Corpbiz Advisors, with experience in business registrations, regulatory compliance and legal documentation. He focuses on helping businesses understand Indian regulatory requirements and complete compliance processes with proper documentation.
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