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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.

Distributors must comply with Good Distribution Practice (GDP) principles as outlined in PIC/S Guide to Good Distribution Practice (or equivalent MDA guidance). This includes maintaining written procedures for temperature monitoring, security, handling of recalls, and record-keeping. MDA may audit distributors to verify GDP compliance during licensing renewal or following serious incidents.