Neutral Code Certificate

For medical device and pharmaceutical manufacturers aiming for international markets, a Neutral Code (also known as a Special Code) is a strategic identifier. Issued by India’s Central Drugs Standard Control Organization (CDSCO), this code allows you to export your products without disclosing your company’s name and address directly on the product label.

What is a Neutral Code?

·         A Neutral Code serves as a confidential identifier that replaces your company’s explicit name and address on the product label. This is particularly valuable when:

The importing country or buyer has specific labeling regulations that differ from your standard domestic labeling.

·         You wish to maintain the confidentiality of your manufacturing identity for various commercial reasons.

Why is a Neutral Code Important for Your Export Strategy?

Utilizing a Neutral Code can significantly streamline and benefit your export operations:

• Facilitates Export Compliance: It enables you to meet diverse international labeling requirements without altering your primary manufacturing information.
• Ensures Confidentiality: Allows you to maintain discretion regarding your manufacturing identity on exported products.
• Simplifies Export Logistics: By offering a flexible labeling solution, it can simplify the overall export process and reduce potential compliance hurdles.
• Expands Market Access: Equips you to cater to a wider range of international markets with specific labeling demands, potentially increasing your global reach.

CDSCO's Role & Eligibility

In India, the CDSCO is the sole regulatory authority responsible for approving and issuing Neutral Codes for both medical devices and pharmaceutical products.

To be eligible for a Neutral Code, manufacturers typically need to possess:

• A valid manufacturing license.
• Product permission for the devices intended for export.
• Other relevant documents as per specific product and regulatory requirements.

The Application Process

The application process for a Neutral Code is managed by the CDSCO. For medical devices, the CDSCO has now streamlined this through an online application process. This generally involves submitting your application along with all necessary supporting documents.

How MDR Consultants Can Assist You

Navigating the nuances of export regulations and specific codes can be complex. Our expert MDR consultants can provide comprehensive support in:

1. Eligibility Assessment: Confirming your eligibility and guiding you on the specific documentation required.
2. Document Preparation: Assisting in the meticulous compilation of your valid manufacturing license, product permissions, and other necessary papers.
3. Online Application Management: Guiding you through the CDSCO’s online application portal for a seamless submission.
4. Liaison & Follow-up: Acting as your representative with the CDSCO to ensure a smooth review process and the timely issuance of your Neutral Code.

Unlock your international market potential with a Neutral Code. Partner with us to ensure a compliant and efficient export strategy for your medical devices.