Health Supplement Registration

Comprehensive support for registering vitamins, minerals, and functional supplements. Expert guidance on product classification and claims substantiation.

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Service Overview

Health supplements in Malaysia are regulated under the Drug Control Authority (DCA). They must be registered with the NPRA to ensure they are safe, of quality, and their claims are not misleading. Misclassification between food and supplement is a common pitfall.

ARCI assists in the critical "Food-Drug Interphase" classification to determine the correct regulatory route, followed by Complete dossier "review and compilation" for NPRA submission.

Who This Is For

  • Supplement brand owners.
  • Direct selling companies.
  • Importers of dietary supplements.

Our Approach

1. Classification Check

Determining if your product is a Health Supplement or Food (FDI) to avoid rejection.

2. Formulation Review

Verifying active ingredient limits against the Drug Registration Guidance Document (DRGD).

3. Label Compliance

Ensuring product labels meet strict MOH requirements prohibiting curative claims.

4. Post-Market Surveillance (PMS) Support

Advisory and operational support to brand owners in meeting post-market obligations, including:

  • Product Complaint Handling
  • Adverse Event Reporting
  • Product Recall Management

Supplement Registration FAQs

How long does it take to register a supplement? ▼
The evaluation timeline from the authority is approximately 100 - 120 working days for standard registration, provided all data is complete and accurate upon submission.
Can I sell my product while registration is pending? ▼
No. It is an offense to sell or distribute unregistered health supplements in Malaysia. You must wait for the MAL number issuance.