You are using an outdated browser and your browsing experience will not be optimal. Please update to the latest version of Microsoft Edge, Google Chrome or Mozilla Firefox. Install Microsoft Edge

December 6, 2023

Laos Implements Medical Device Registration and Notification Requirements

Subscribe to Updates

New regulatory requirements for medical device registration and notification in Laos are set to enter into force in the coming weeks under the plan found in Notification No. 9606 to implement Decision No. 1470/MOH on Registration and Notification of Medical Devices (Decision 1470). The notification, issued on October 25, 2023, by the Food and Drug Department (FDD) under the Ministry of Health (MOH), outlines the FDD’s strategic plan for phased-in registration and notification requirements for medical devices.

In the first phase, starting January 1, 2024, the FDD will initiate the registration process for class C (moderate-high risk) and D (high risk) medical devices. Meanwhile, operators dealing with class A (low risk) and B (low-moderate risk) devices can continue applying for import permits without having to register the devices or notify the FDD.

In the subsequent phase, starting January 1, 2025, operators will have to notify the FDD about class A devices and complete the registration process for class B devices.

To prepare for these requirements, import-export companies in the pharmaceutical and medical products sector must submit a list of medical devices, including their classification based on the country of manufacture, to the FDD by December 15, 2023. This measure is aimed at enabling the FDD to streamline the collection, guidance, and preparation processes to ensure efficient registration within the set time frame. While import-export companies can still submit their lists after either December 15, 2023, or January 1, 2024 (the registration commencement date), registration may be delayed since the FDD will prioritize those who submit their lists by the December 15 deadline. The list of medical devices should encompass medical devices imported in the past as well as those intended for future import permission applications.

During the initial registration stage (i.e., from January 1, 2024), import-export companies that are unable to submit all documents for registration according to the ASEAN Common Submission Dossier Template can submit a subset of essential documents to the FDD. These documents must be accompanied by a letter indicating when the complete set of documents can be provided.

For domestic factories seeking to register medical devices or notify the FDD, a key factor is the risk classification of the medical device, as outlined in Decision 1470. The decision sets out 24 principles for determining the purpose of medical devices in each class, providing a framework for factories to classify their medical devices. However, the FDD retains the authority to reclassify devices if the initial classification by the domestic factory or importer-exporter is deemed inaccurate.

For medical devices that cannot be classified according to the ASEAN harmonized risk classification list for medical devices, the FDD will ascertain the associated risk through its own technical assessment and decision-making process. Medical devices that potentially fall into multiple risk categories will be assigned the highest applicable risk category.

For more details on medical device registration and notification requirements in Laos, please contact Tilleke & Gibbins at [email protected].

Related Professionals

Industries

Life Sciences

Practices

Regulatory Affairs

Location

RELATED INSIGHTS​ 

September 28, 2026
On September 15, 2026, the Thai Food and Drug Administration (Thai FDA) opened a public consultation period on the principles of a proposed Ministry of Public Health (MOPH) notification establishing specific Good Manufacturing Practice (GMP) requirements for foods derived from cultured animal cells. The proposal would build on Thailand’s existing safety assessment framework by proposing GMP requirements specifically tailored to the production of cultivated meat. As cultivated meat advances toward commercial production, its unique manufacturing processes present food safety challenges involving aseptic conditions, starting cell quality, culture media, and specialized equipment. Thailand’s Food Act B.E. 2522 (1979) provides the legal basis for regulating food manufacturing, but no GMP requirements specifically tailored to cultivated meat have been issued under it. The proposed framework aims to address this gap. The Thai FDA has not yet released a complete draft notification, so the proposed requirements outlined below may change before adoption. However, they indicate the direction the regulator intends to take, and companies preparing to enter the Thai market can use them now to anticipate their compliance obligations. What Is Cultivated Meat? Cultivated meat, also known as cell-based food or cell-cultured meat (and referred to in the proposed notification as food derived from cultured animal cells), is produced by cultivating animal cells rather than raising and slaughtering animals through conventional meat production. The process generally begins with the selection of animal cells or stem cells, which are cultivated in an appropriate culture medium within a bioreactor to promote cell growth and proliferation. Scaffolding materials or other techniques may subsequently be used to develop cells into tissue or other forms suitable for consumption. Unlike conventional meat production, this process introduces specific food safety considerations relating to starting cells, culture media, production substances, contamination controls, and potential residues in the final product. Thailand’s Safety
Read More
September 9, 2026
On August 5, 2026, the Consumer Case Division of Thailand’s Civil Court rendered a judgment in a case involving a beauty clinic that advertised acne scar treatments using claims that the clinic was operated by a specialist physician and that the treatment, allegedly involving stem cell technology, could permanently remove acne scars. The plaintiff brought a claim against both the physician-owner and the clinic company, alleging that the advertisements were false and induced her to purchase the treatment. The court found that the clinic was liable for the false representations and that the physician-owner, as both the authorized director of the company and the medical practitioner who provided treatment, was jointly responsible. Although the plaintiff could not fully prove all damages claimed, the court awarded compensation of THB 20,000, together with interest. While the judgment arose from a consumer protection dispute, it serves as a valuable reminder that medical facility advertisements in Thailand are regulated and may expose clinics and healthcare providers not only to regulatory enforcement but also to civil liability from patients who rely on misleading promotional claims. Regulatory Framework Governing Medical Facility Advertisements Medical facility advertising in Thailand is governed by the Medical Facility Act B.E. 2541 (1998), as amended by the Medical Facility Act (No. 4) B.E. 2559 (2016). The principal secondary legislation is the Department of Health Service Support (DoHSS) Notification Re: Rules, Procedures, Conditions, and Fees for an Advertisement or Publication Concerning a Medical Facility, which came into force on November 25, 2019. Under this notification, “advertising” includes any act, by any means, that causes members of the public to see, hear, or otherwise become aware of a message, sound, or image for the commercial benefit of a medical facility. This broad definition covers not only traditional media but also clinic websites, social
Read More
September 9, 2026
On June 30, 2026, Indonesia’s National Agency of Drug and Food Control (BPOM) issued BPOM Regulation No. 11 of 2026 on Food Packaging, which expands the list of approved food-contact substances and recognizes a broader range of permissible functions for those substances. The new regulation, which revokes BPOM Regulation No. 20 of 2019, reflects developments in packaging technology and materials science. Although the new regulation provides more advantages to business actors by adding more food contact substances to the approved list for use in food packaging, there are more stringent rules and restrictions for testing. One of the most significant changes is a comprehensive migration-testing framework that sets out requirements for packaging materials, testing conditions, food simulants, and specific migration limits. Overall and Specific Migration Under BPOM Regulation No. 20 of 2019, migration requirements were primarily set out within the lists of approved food-contact substances and packaging materials. BPOM Regulation No. 11 of 2026 instead expressly requires packaging materials that come into direct contact with food to meet both overall and specific migration limits. These are defined as follows: Overall migration: The total quantity of all substances that migrate from the packaging, regardless of whether the substances are hazardous or nonhazardous to health. Specific migration: The quantity of a particular identified substance known to be hazardous to health that migrates from the packaging. Stricter Limits on Heavy Metals The overall migration limit for plastic packaging remains unchanged under both regulations at 60 mg/kg or 10 mg/dm². However, the new regulation introduces significant changes to the regulation of heavy metals. Under the 2019 regulation, four heavy metals—lead, cadmium, chromium VI, and mercury—were subject to a single combined limit of 1 mg/kg. The 2026 regulation, however, requires each heavy metal to meet its own individual specific migration limit, adds arsenic as
Read More
September 7, 2026
Indonesia’s Constitutional Court (Mahkamah Konstitusi) has reinstated a key provision limiting pharmaceutical patent protection, signaling a renewed commitment to balancing patent rights with public access to medicines. In its ruling to Case No. 255/PUU-XXIII/2025, the court partially granted a petition for judicial review of Law No. 65 of 2024, which had amended the country’s Patent Law, and ordered the restoration of a provision that had excluded certain pharmaceutical inventions from patentability. The decision took effect immediately upon its pronouncement at the court’s plenary session on August 28, 2026. Background The petition challenged the removal of article 4(f) from Law No. 13 of 2016 concerning Patents (Patent Law), as amended by Law No. 65 of 2024. Article 4(f) had excluded from patentability certain inventions relating to new uses of known substances. The petitioners argued that removing this provision would open the door to patent protection for second medical use inventions and facilitate patent evergreening—practices that can extend exclusivity periods, delay generic market entry, and reduce public access to affordable medicines. The petitioners included several patient advocacy and public-interest organizations: the Indonesian Dialysis Patients Community Association, the Indonesian Association of Drug Abuse Victims (PKNI), the Indonesian Pulmonary Hypertension Foundation (YHPI), the Rekat Peduli Indonesia Foundation, and the Indonesian Positive Women’s Association (IPPI), along with the Indonesia for Global Justice Association and four individual petitioners. The petitioners also challenged the constitutionality of the phrase “interested party” in article 70(1) of the Patent Law, arguing that it should be construed expressly to clarify who has standing to appeal a decision to grant a patent before the Board of Patent Appeal, and to allow a broader range of parties—such as patent holders, licensees, consumer organizations, prosecutors, aggrieved third parties, and others who may suffer direct or indirect harm from the grant of a patent—to
Read More