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GDP, Storage & Distribution

All entities involved in distributing medical devices in Vietnam — importers, distributors, and wholesalers — must comply with Good Distribution Practice (GDP) requirements to maintain product quality and safety throughout the supply chain.

What is GDP?​

GDP is a set of standards ensuring that medical devices are consistently stored, transported, and handled under suitable conditions throughout the distribution chain, from manufacturer or importer through to the end user or healthcare facility.

Key GDP requirements under Decree 98/2021​

Storage facilities​

  • Storage areas must be maintained under conditions specified by the device manufacturer (temperature, humidity, light)
  • Storage areas must be clean, secure, and protected from contamination
  • Controlled access to storage areas must be in place
  • Segregation of compliant, quarantined, and rejected stock
  • Pest control and environmental monitoring (temperature/humidity logging for sensitive devices)

Cold chain devices​

Devices requiring refrigeration or freezing (e.g. certain IVD reagents, biological samples) must be handled under validated cold chain conditions:

  • Validated refrigeration/freezing equipment with continuous temperature monitoring
  • Temperature excursion procedures and records
  • Cold chain continuity throughout transport
  • Qualified cold chain transport providers

Distribution records and traceability​

Full traceability of each device from importer to end customer is required:

  • Records of all inbound and outbound transactions
  • Batch/lot number tracking (where applicable)
  • Records of storage conditions during warehousing
  • Delivery records including recipient details
  • Records must be retained for a minimum period specified in Decree 98/2021 (typically at least the lifetime of the device or 5 years, whichever is longer)

Handling complaints and returns​

  • A formal procedure for handling customer complaints relating to device quality must be in place
  • Returned devices must be quarantined pending assessment
  • Potentially defective or non-conforming devices must be segregated and reported per incident reporting obligations

Distribution chain and FSCA​

In the event of a Field Safety Corrective Action (FSCA), distributors must be able to:

  • Rapidly identify all affected lots distributed
  • Contact affected customers within the timeframe specified in the FSCA plan
  • Coordinate with the Authorised Representative or manufacturer on recall or correction activities

→ See FSCA & Recalls

DMEC portal — distribution records​

DAV may audit distribution records through the DMEC system or during inspection visits. Maintain records in a format that allows rapid retrieval and presentation to inspectors.