Essential Customs Checklists for Importing Cosmetics, Drugs, and Medical Devices

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Dated: 04.09.2026

Essential Customs Checklists for Importing Cosmetics, Drugs, and Medical Devices

Importing regulated products such as cosmetics, drugs, and medical devices into India involves strict compliance with government regulations. Circular 40-2026 provides detailed checklists for customs officials and importers to ensure all legal and safety requirements are met before goods are cleared. This article breaks down the essential requirements for each category, helping importers navigate the process efficiently.

1. Importing Cosmetics: Documentation and Compliance

To import cosmetics, the following documents and conditions must be satisfied:

Registration Certificate: A self-certified copy of the Registration Certificate (RC) in Form COS-2 (fresh registration) or COS-4A (subsequent registration) issued by CDSCO.
Invoice and Packing List: Self-certified copies, with the invoice clearly mentioning the cosmetic’s name and matching the RC, including pack size.
Country of Origin Certificate: Self-certified copy required.
Labelling Requirements: Each item must be labelled with:
- Name of the cosmetic
- RC number and registration holder’s details
- Manufacturer’s name and address
- Batch/lot/serial number
- Expiry or use-before date (must be more than six months from import date)
Storage License: Self-certified copy of the licensed premises for storage.
Certificate of Analysis (COA): For each batch, matching the RC.
Prohibited Substances: Declaration that no hexachlorophene is present.
Animal Testing Declaration: Manufacturer’s declaration that no animal testing was conducted.
Packaging Integrity: Importer’s undertaking that packaging is intact and contents are not deteriorated.

2. Importing Drugs: Key Requirements

For drugs, including those for personal use or small quantities for hospitals:

Import Permission: Self-certified copy of permission in Form 12B or Form 11A/CT-25.
Invoice and Packing List: Self-certified copies required.
Quantity Verification: Imported quantity must match the permission granted.
Labelling: Must include manufacturer’s details, batch number, size, manufacturing and expiry dates, import license number, and storage conditions.
Certificate of Analysis: For each batch, matching the RC or Import License.
Storage License: Self-certified copy of valid wholesale/manufacturing license.
Packaging Integrity: Importer’s undertaking on packaging and product condition.
Shelf Life: Residual shelf life at import must exceed 60%. If less, refer to CDSCO port office.

3. Importing Medical Devices: Procedures and Documentation

For medical devices, including those for clinical investigation, demonstration, or personal use:

Import License: Self-certified copy in Form MD-17, MD-19, or permission in MD-21.
Invoice, Packing List, and Country of Origin Certificate: Self-certified copies required, with invoice details matching the import license.
Labelling and Shelf Life: Devices must be labelled with all regulatory details. Minimum residual shelf life requirements:
- At least 40% for devices with a 90-day shelf life
- At least 50% for 90–365 days
- At least 60% for over 365 days
Certificate of Analysis: For each batch, matching the import license.
Storage License: Self-certified copy of licensed premises.
Packaging Integrity: Importer’s undertaking on packaging and product condition.

4. Importing Raw Materials and Components for Medical Devices

Manufacturing License: Self-certified copy in Form MD-05 (Class A & B) or MD-09 (Class C & D).
Invoice, Packing List, and Country of Origin Certificate: Self-certified copies required.

5. Handling Discrepancies

If any discrepancies or doubts arise during verification, the consignment must be referred to the CDSCO Port Office for further examination.

By following these checklists, importers can ensure smooth customs clearance and compliance with Indian regulations for cosmetics, drugs, and medical devices.

In case you face any issues related to Indirect Tax-Customs, GST, Foreign Trade Policy (FTP), Arbitration matters and Central Licensing and related advisory matters in India then please feel free to get in touch with SJ EXIM Services.

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Source: CBIC, Ministry of Finance, Govt. of India

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