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Malaysian Authorities Publish Medical Device Registration Transfer Policy

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EMERGO SUMMARY OF KEY POINTS:

  • The Malaysian MDA has put out new guidance for medical device registration transfers.
  • Registration transfers are only available for devices that have already obtained market authorization from the MDA.
  • Malaysian device registration transfers require cooperation between current and new authorized representatives.

Malaysia MDA medical device registration transfer guidance 2017Medical device market regulators in Malaysia have issued new guidance addressing requirements for transferring device registrations from one authorized representative to another.

The Medical Device Agency (MDA) guidance allows registration transfers only for devices already authorized for sale in Malaysia. Active registration applications under MDA review may not qualify for transfer; they must either be withdrawn or completed before transfer requests can be considered.

A registered device’s current Malaysia Authorized Representative must cooperate with the transfer, according to the guidance, by completing an “AR Declaration Form” and providing all relevant documentation—including distribution and complaint records—to both the new authorized representative and MDA reviewers.

However, if a device’s existing authorized representative does not agree to a registration transfer, the device manufacturer may have to wait until its current registration expires and then re-register using a new authorized representative.

The MDA anticipates 30-day review timeframes for processing registration transfer applications.

For more information on Malaysian medical device registration and approval, read our whitepaper or download our regulatory process chart.

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