Medical Device Regulatory Requirements in Laos

Regulatory Authority Ministry of Health and Prevention
Regulatory Authority Website Link Click Here
Device Classification A,B,C,D
Medical Device Regulations Law on Drugs and Medical Products | Click Here
Registration Process Medical Device Registration and Notification | Click Here
Registration Timeline 3 months
Technical Documentation Format

Article 8:
Member States shall undertake appropriate measures to adopt and implement the following common technical documents:
(a) Annex 4 - ASEAN Common Submission Dossier Template (CSDT);
(b) Annex 5 - Post Marketing Alerts System (PMAS) Requirements; and
(c) Annex 6 - Harmonised set of elements for a Product Owner’s or Physical Manufacturer’s Declaration of Conformity (DoC).

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Requirement of Authorized Representative Yes
Language Requirement Labels must be in Lao language
Fees for Submission

Registration fees for imported medical equipments are as followings: + fees: - medical equipment A with low risk (voluntary) is 500.000 kip/year/time/item - medical equipmetn B with low to medium risk is 1.200.000 kip/year/time/item - medical equipment C with medium to high risk is 1.600.000 kip/year/time/item - medical equipment D with high risk is 2.000.000 kip/year/time/item + service charges: research and consideration for the registration of medical equipment is 100.000 kip/item

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Certificate of Free Sale

Imported and locally produced class B, C, and D medical devices must be registered with the  Ministry of Health’s Food and Drug Department (FDD. Class A medical devices, as well as domestically manufactured medical devices of all classes for export, only require a formal notification to the FDD.

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Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.

The above information is last updated on 05/Jul/2025

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