Laos’ Ministry of Health (MOH) has promulgated a regulation detailing registration and notification protocols for medical devices. Decision on the Registration and Notification of Medical Devices No. 1470/MOH will come into force 60 days after both the signing of the regulation (which already occurred in July) and publication in the Official Gazette, which has not yet been specified by the government.
Registration of medical devices in Laos is mentioned in the country’s Law on Drugs and Medical Products No. 07/NA, dated December 21, 2011, but a registration procedure has not been put in place. There was only a separate requirement to furnish certain required documents when importing medical devices. Now, the decision outlines the registration and notification process for medical devices through the Ministry of Health’s Food and Drug Department (FDD), in line with the regulatory principles in the ASEAN Medical Device Directive of 2015, which Laos has ratified.
Medical Devices in Laos
The decision defines medical devices as any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material, or other similar or related article intended for any of the following uses in humans:
- Diagnosis, prevention, monitoring, recovery from, or alleviation or treatment of a disease;
- Diagnosis, monitoring, recovery from, or alleviation of or compensation for an injury;
- Replacement, modification, or support of anatomy or a physiological process;
- Supporting and sustaining life;
- Controlling or assisting in conception; or
- Disinfection and sterilization of tools and medical devices.
Medical devices in Laos are given one of four classifications based on their level of risk:
- Class A – Low risk (e.g., rubber belts, cotton for medical purposes, nonwoven swabs, adhesive bandages)
- Class B – Low-moderate risk (e.g., neonatal suction equipment, surgical gloves, gastro-catheters)
- Class C – Moderate-high risk (e.g., endoscopic surgical equipment, anesthesia equipment, peritoneal dialysis equipment)
- Class D – High risk (e.g., cardiological catheters, craniotomy surgical equipment)
Registration and Notification
Imported and locally produced class B, C, and D medical devices must be registered with the 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.
The registration and notification requirements are waived for medical devices imported and designed for individual use in limited quantities or for exhibition purposes within Laos. These devices must not be intended for distribution, and they must be returned to their country of origin or exported onward within a stipulated timeframe.
Additionally, this exemption from registration and notification also extends to medical devices that have undergone refurbishment for the sole purpose of reuse. This applies exclusively to medical devices that are eligible for refurbishment and reuse, intended solely for donation or grant initiatives. Any refurbishment must adhere strictly to the the refurbishment guidelines laid out in the ASEAN Medical Device Directive of 2015.
Medical device registration and notification can be done by locally incorporated importers and drug and medical product manufacturers by submitting the required documents to the FDD. Medical device registration certificates are valid for five years and can be renewed 90 working days before the expiration date.
As noted above, the Decision on the Registration and Notification of Medical Devices is part of Laos’ intention to bring its regulatory framework closer to the ASEAN Medical Device Directive of 2015. This is a welcome development for medical device businesses, as this development underlines Laos’ efforts to elevate its regulatory standards as it prepares to assume the role of the chairmanship of ASEAN in 2024.
For more details on the registration and notification requirements, or on any aspect of medical device regulations in Laos, please contact Tilleke & Gibbins at [email protected].