Medical Device Registration and Filing Agreement
医疗器械注册与备案协议
ຂໍ້ຕົກລົງວ່າດ້ວຍ ການຂຶ້ນທະບຽນ ແລະ ຈົດແຈ້ງອຸປະກອນການແພດ
Summary
This regulation governs the production, import, export, storage, and distribution of medical devices in Laos, with core classification by risk level, requiring registration for high-risk devices, filing for low-risk devices, and specifying emergency use authorization procedures.
Articles
Article ມາດຕາ 1
Article 2 Scope of Application
This agreement applies to officials managing food and drugs, organizations and operators engaged in the business of production, import-export, storage and distribution of medical devices in the Lao PDR.
Article ມາດຕາ 2
Article 4 Principles of Registration and Notification of Medical Devices
1. Be in accordance with policies, regulations, laws and directions of public health service work.
2. Be in accordance with principles and guidelines that are unified in ASEAN and internationally.
3. Build capacity and ensure efficiency in the registration and notification of medical devices.
Article ມາດຕາ 3
Article 5 Classification of Medical Devices
Medical devices are classified according to risk level as follows:
Class 1 Low risk
Class 2 Low to moderate risk
Class 3 Moderate to high risk
Class 4 High risk
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