Wet wipes are now a part of daily essentials, from infant skin care and personal hygiene to hospital-grade sanitisers. Based on the purpose and content, it is mandatory to obtain CDSCO registration for wet wipes before being sold in the Indian market.
Whether you manufacture, import, or are a proprietor of a brand, it becomes crucial to understand the wet wipes regulatory process. This helps avoid non-compliance and product recall. In this guide, we clarify all that you need to learn regarding CDSCO registration for wet wipes. This includes procedures, categories, documents required, and even advice from experienced experts to obtain faster approval.
What is CDSCO Registration?
The Central Drugs Standard Control Organization (CDSCO) serves as a national regulator for medical equipment, cosmetics, and pharmaceuticals in India. The CDSCO also works as a part of the Directorate General of Health Services within the Indian Ministry of Health and Family Welfare.
Wet wipes—medicated or disinfectant wipes—can be classified by the CDSCO as cosmetic products or medical devices depending on their intended use and the ingredients used in their composition.
Why Is CDSCO Registration Important For Wet Wipes?
For medicated, disinfectant, or antiseptic wet wipes, CDSCO registration is very important, particularly in health or clinical environments. For a product to be legally marketed in India, it must comply with the regulatory requirements set forth by the Medical Device Rules, 2017, ensuring that the product is safe, effective, and of good quality.
Key Reasons Why CDSCO Registration Is Important:
- Legal Compliance: Mandatory for disinfectant or medical-use wipes.
- Product Safety: Confirms the product is safe for public use.
- Market Access: Required to sell or distribute in the Indian market.
- Brand Trust: Enhances credibility with consumers and health authorities.
- Avoid Penalties: Prevents legal issues, product recalls, or import bans.
If your wet wipes are intended for use other than cosmetics, CDSCO registration is not optional, it’s essential for market entry and consumer safety.
Types of Wet Wipes and Their Classification
Wet wipes are classified based on their use and ingredients. This helps determine whether CDSCO registration is required.
| Type of Wet Wipe | Use | Classification | CDSCO Registration |
|---|---|---|---|
| Cosmetic Wipes | Skin cleansing | Cosmetic | Not required |
| Medicated/Antiseptic Wipes | Skin treatment/disinfection | Medical Device | Required |
| Disinfectant Wipes | Surface/equipment cleaning | Medical Device | Required |
| Hygiene Wipes (Therapeutic) | Infection prevention | Drug/Device | Required |
CDSCO Registration Process for Wet Wipes (Medical Device Category)
Registering Wet Wipes with CDSCO includes various steps, such as:
Step 1: Check Device Notified Status
Confirm that your wet wipe product is a notified medical device under CDSCO’s classification list. Use the CDSCO Medical Device Portal to check updated lists.
Step 2: Appoint an Indian Authorized Agent (For Importers Only)
Foreign manufacturers must appoint an Indian Authorized Agent (IAA) to represent them in all CDSCO communications.
Step 3: Prepare Required Documents
To apply for CDSCO registration of wet wipes, you must prepare a complete set of regulatory documents. Proper documentation ensures faster approval and compliance with Indian regulatory standards. Below, we have attached the list of the essential documents required for cdsco registration for wet wipes registration.
Step 4: Submit Application on CDSCO SUGAM Portal
Use the CDSCO SUGAM portal for online registration. Pay the applicable government fees.
Step 5: Evaluation and Grant of Registration
CDSCO will evaluate your application and may raise queries. Upon successful review, you will receive a Registration Certificate (Form MD-15 for importers or Form MD-6 for manufacturers).
Documents Required for CDSCO Wet Wipes Registration
Here we have provided a list of essential documents required for cdsco certification for wet wipes:
- Covering Letter
- Form MD-14 / MD-3
- Free Sale Certificate (FSC)
- Certificate of Analysis
- Product Labels & Artwork
- ISO 13485 Certification
- Device Master File (DMF)
- Plant Master File (PMF)
- Test Reports
- Details of Manufacturing Process
Timeline and Cost of CDSCO Registration
- Timeline: Typically 6–9 months, depending on documentation and review process
- Government Fees: Varies depending on product category and application type
- Professional Charges: May apply if using a regulatory consultant like cosmeticsregulatory.com
Labeling Requirements for Wet Wipes
Regardless of classification, wet wipes must comply with the labeling norms outlined under:
Cosmetic Labeling Rules (if classified as cosmetic)
Medical Device Labeling Rules under MDR 2017 (if classified as a medical device)
Key details to include:
- Brand and product name
- Ingredients
- Batch number and manufacturing date
- Expiry date
- Net quantity
- Manufacturer/importer details
- Usage instructions and warnings
Is CDSCO Registration Mandatory For All Types Of Wet Wipes In India?
No, CDSCO registration is only mandatory for wet wipes with medicated, antiseptic, or disinfectant properties. Regular cosmetic wipes for skin cleansing do not require CDSCO registration.
What Documents Are Needed For CDSCO Registration Of Wet Wipes?
Documents such as the covering letter, MD-14 or MD-3 form, Free Sale Certificate (FSC), Certificate of Analysis, ISO 13485 certificate, Device Master File (DMF), Plant Master File (PMF), product labels, and manufacturing process details are needed.
How Long Does The CDSCO Registration Process Take For Wet Wipes?
The CDSCO registration process takes approximately 6–9 months from the date complete documentation is submitted to the completion of the regulatory review process.
