- Your Strategic Partner For Regulatory Compliance
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.
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:
Utilizing a Neutral Code can significantly streamline and benefit your export operations:
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:
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.
Navigating the nuances of export regulations and specific codes can be complex. Our expert MDR consultants can provide comprehensive support in:
Unlock your international market potential with a Neutral Code. Partner with us to ensure a compliant and efficient export strategy for your medical devices.
Don’t wait! Contact MDR consultant today to discuss your specific needs and get a free quote. With their expertise, you can obtain your Free Sale Certificate efficiently and confidently, paving the way for successful medical device export.
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