Medical Device Registration in Laos: FDD Regulations and Procedures

Regulatory Authority: Food and Drug Department (FDD)

The Food and Drug Department (FDD) is the regulatory authority in Laos and regulates pharmaceuticals and medical devices.

The manufacturer shall register the drugs and medical products with the (Ministry of Health) MOH to sell in Laos. The MOH is required to issue a certificate stating the drug conforms to legal health standards.

MOH must inspect and analyze drugs and medical products to determine whether they conform to established safety and efficacy standards, prior to registration.

Link for Regulatory Authority

http://www.fdd.gov.la/index_en.php

Local Regulation

ASEAN Medical Device Directives Drug and Medical Product Law

Overview

Class B, C, and D medical devices, whether imported or locally produced, necessitate registration with the FDD, while Class A devices and domestically manufactured medical devices of all classes intended for export only require a formal notification to the FDD.

For medical devices imported and intended for individual use in limited quantities or for exhibition purposes within Laos, registration and notification requirements are waived. However, these devices must not be intended for distribution and must be returned to their country of origin or exported within a specified timeframe.

This exemption also applies to medical devices refurbished for reuse, specifically those eligible for refurbishment and reuse for donation or grant initiatives. The refurbishment process must strictly adhere to the guidelines outlined in the ASEAN Medical Device Directive of 2015.

Locally incorporated importers and drug and medical product manufacturers can handle medical device registration and notification by submitting the necessary documents to the FDD. Medical device registration certificates are valid for five years and can be renewed 90 working days before the expiration date.

Classification of Medical Devices

• Class A
• Class B
• Class C
• Class D

Listing or Registration Requirements

• • Determine the device classification
  • Appoint authorized representative
  • Prepare the Technical Documents
  • Submit the application form and technical documents to the FDD
  • Once approved, the device can be marketed in Laos

Documents Required for Registration

• Application Form
• Common Submission Dossier
• Product Information
• Commercial marketing history
• Labelling and Package Insert
• List of Regulatory Approvals
• Safety and performance related information
• Clinical Studies
• Risk Analysis
• Manufacturing Process
• Post Marketing Alerts System (PMAS)
• Declaration of Conformity

Registration Timeline

• Class A
• Class B
• Class C
• Class D

License Validity

5 years

Who should make this Communication?

• Manufacturer
• Authorized Representative

When to make this Communication?

Before placing a medical device into the market.

How OMC Medical can assist you with the process?

• Act as your Authorized representative

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk