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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