Lao PDR: Medical Device Economy & Regulatory Update

August 28, 2019

Medical Device control system

  • In Laos there are 72 Import drug-medical device companies, who are representative for local distribution. There are 34 companies run business for medical devices, 1 Medical Device Factory

  • Almost 100% of medical device products are imported for the local consumption.

  • The medical device procurement for public health facility through centralized bidding process (procurement committee)

  • The medical device placed in some health facilities such as central hospital or some provincial hospital is under the Public Private Partnership

  • The importation of medical device is not yet required for Registration

  • The FDD issued import license certificate based on importation request submission. (single use of import license and must be Inspected at the Port of Entry (International Check points, 27 Check points)

  • Amount of imported medical devices is increasing

 

Gantt Chart for Laos on AMDD Implementation

 

Pre-market’s Pathway Plan for Medical Device

  • The definition of medical device is referred to AMDD

  • Medical device has classified in A, B, C and D

  • The registration will be required for class B, C and D.

  • For class A will be required to notification

  • The Common Submission Dossier Template will be required for class C and D registration

  • The medical device import for national Health Program will be required for fast tract registration

  • The registration fees will be required in difference class of the device (50 – 200 USD).

  • The validity of Registration will be 5 years

     

Reference: Laos Food And Drug Department

 

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