Neutral Code Certificate
(Special Code)
Maintain confidentiality and seamlessly navigate diverse international labeling requirements with a CDSCO-issued Neutral Code for your exports.
Consult Our CDSCO Experts
What is a Neutral Code?
For eligible medical-device exports, a Neutral Code provides an alternative manufacturer identifier under the applicable export-labelling provisions. Its use must meet the Indian requirements and the importing country's rules; it does not replace product licensing or destination-market authorisation.
This is particularly valuable when:
- The importing country or buyer dictates specific labeling regulations that conflict with your standard domestic labeling practices.
- You strategically wish to maintain the confidentiality of your manufacturing identity from end-users or competitors in foreign markets.
Why is it Crucial for Your Export Strategy?
Ensures Confidentiality
Allows you to maintain complete discretion regarding your manufacturing identity on exported products, protecting your intellectual property and market position.
Facilitates Export Compliance
Enables you to seamlessly meet diverse and stringent international labeling requirements without constantly altering your primary manufacturing documentation.
Expands Market Access
Equips you to cater to a wider range of international buyers and contract manufacturing clients who demand specific, unbranded, or custom-branded labeling.
Eligibility & The Application Process
In India, the CDSCO is the sole regulatory authority responsible for approving and issuing Neutral Codes. To be eligible, manufacturers typically must possess a valid manufacturing license and established product permissions for the devices intended for export.
CDSCO announced a system-generated Neutral Code facility through the Medical Devices Online portal in April 2025. Check the current portal process, manufacturing credentials and export scope before applying. Read the CDSCO notice.
Unlock International Markets
Navigating the nuances of export regulations and specialized codes can be complex. We ensure your export strategy is legally robust and confidential.
- Eligibility & documentation assessment
- CDSCO online portal management
- Direct liaison for timely issuance