Current situation in Laos:
36 Companies involved in medical device market
1 medical device factory
98% of medical devices are imported
Public Private Partnership covers medical devices placed in healthcare facilities such as the central hospital or certain provincial hospital
Registration is not required for medical device importation
The AMDD (ratified in 2015) is used as a reference for the steps forward to the control system for medical devices and is in a transition to comply with the laws and regulations in Laos.
The country is now adopting medical device classification rules based on the AMDD. Medical devices will be categorized into class A, B, C and D, where class A has the lowest risk and class D has the highest risk. Product registration is required for class B, C and D medical devices while class A devices will be subjected to notification requirements.
The use of Common Submission Dossier Template (CSDT) will be mandatory for class C and D medical device registration, and registration fees will range from USD 50 - 200 based on the risk level. Fast track registration is available for imported medical device under the National Health Program. The validity of registration will be 5 years.
The new registration process is expected to commence in 2019 and will be in effect within 3-6 months from the date of publication.
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