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Distributor Licence

Who is a Distributor?​

A distributor is any natural or legal person in the supply chain — other than the manufacturer or importer — who makes a medical device available on the Malaysian market. Distributors typically purchase from importers and supply to hospitals, clinics, or retailers.

Licence Requirement​

All distributors of medical devices in Malaysia must hold a valid distributor establishment licence from MDA.

This includes:

  • Wholesalers supplying to healthcare facilities
  • Sub-distributors in multi-tier supply chains
  • Dealers selling directly to end users (hospitals, clinics, patients)

Key Obligations of Distributors​

Storage and Handling​

  • Maintain storage conditions as specified by the manufacturer (temperature, humidity, light)
  • Keep records of storage conditions for temperature-sensitive devices
  • Segregate expired, damaged, or recalled stock from usable inventory

Traceability​

  • Maintain records of all received and supplied devices including:
    • Product name and DRN (Device Registration Number)
    • Lot/batch number
    • Quantity received and dispatched
    • Supplier and customer details
    • Receipt and dispatch dates

Complaint Handling​

  • Maintain a documented procedure for handling complaints about device performance
  • Forward technical complaints to the importer or manufacturer
  • Retain records of all complaints received

Adverse Events and Recalls​

  • Report serious incidents to MDA within required timelines if first aware of the incident
  • Cooperate with importer/manufacturer in implementing recalls and FSCAs
  • Be able to identify and quarantine recalled products within their inventory

What Distributors Must NOT Do​

  • Must not re-label or re-package a device in a way that contradicts the original registration
  • Must not distribute unregistered devices — verify the DRN before accepting new product lines
  • Must not distribute to unlicensed entities engaged in regulated activities

Documentation Required for Application​

  • SSM registration
  • Physical premises evidence
  • QMS/GDP procedure overview
  • Responsible person details
  • List of device categories to be distributed (optional but recommended)

Annual Renewal​

Distributor licences are renewed annually via MyMDA. The renewal fee is RM 500.

Multi-Site Distributors

If a distributor operates from multiple warehouses or sites, each site may need to be covered by the licence. Confirm with MDA whether separate licences are required for each location.