Registration and Notification of Medical Devices

With the publication of Decision No. 1470/MOH on the Registration and Notification of Medical Devices dated 11 July 2023 (“Decision 2023”) on the Lao Official Gazette website earlier this year, we wanted to provide a brief overview of its provisions.

Decision 2023 sets out guidelines for registration and notification procedures relating to medical devices, and is applicable to organizations and business operators engaged in the manufacture, import-export, storage, and distribution of medical devices in the Lao PDR.

Medical device registration and notification

Medical device registration and notification involve the submission of different levels of detailed information regarding a medical device, including its name, intended use, international identification and classification codes, and the names and addresses of its manufacturer and distributor.

Registration is a more stringent process, requiring a summary of the device based on the ASEAN Common Submission Dossier Template. Notification, on the other hand, involves providing specific regulatory information related to the medical device. Whether registration or only notification is required depends on its classification (see below).

Medical device classifications

• Class A: Low risk
• Class B: Low to medium risk
• Class C: Medium to high risk
• Class D: High risk

Classes B, C, and D medical devices must be registered with the Food and Drug Department (“FDD”) of the Ministry of Health, while Class A medical devices and medical devices manufactured in the Lao PDR solely for export only require notification to the FDD.

Types of registration and notification

• Emergency approval: This registration applies in situations of an epidemic or disaster where the use of a Class B, C, or D medical device is necessary and no suitable alternative medical device is available.
• Fast/immediate registration: This registration applies to the importation or production of a Class B, C, or D medical device intended for humanitarian use or use in projects acknowledged by the relevant authorities. It also applies to medical devices already registered in a country with a well-established regulatory system, as determined by the FDD.
• Registration or notification of medical devices in a family grouping classification: This approach applies when medical devices meet the following criteria:
  • They are from the same producer;
  • They have the same risks;
  • They share the same intended use;
  • They have the same or similar structural characteristics design and production process;
  • Their differences are considered minor and acceptable; and
  • They are under the same product name and trade name.
• Registration or notification of medical devices in a system grouping classification: This approach applies when medical devices meet the following criteria:
  • They are produced by a single manufacturer, or by multiple manufacturers under a common product owner;
  • They share the same intended use;
  • They are intended to be used together; and
  • They are distributed under a single system name.

Exceptions to medical device registration and notification

This approach applies to the following categories of medical devices:

• Medical devices designed for individual use or for exhibition purposes, and intended to be returned to the country of origin or exported within a specified period.
• Refurbished or reconditioned medical devices intended for donation or aid purposes, in accordance with the Good Refurbishment Practice for Medical Devices.

Registration and notification timeline

Upon receipt of a complete application for the registration or notification of a medical device, the FDD will review the application and conduct a technical assessment within 60 working days for the registration of Class C and D medical devices, 30 working days for the registration of Class B medical devices, and 15 working days for low-risk medical devices and those that are already registered in a country with a well-established regulatory system.

Following the issuance of the technical assessment summary, the FDD may request additional information, reject the application, or approve the application and issue the medical device registration or notification certificate to the applicant within 10 working days.

If the registration or notification requires review and recommendation by the Medical Device Technical Committee, the process will take up to 15 working days from the date the technical assessment summary is issued.

Validity of the medical device registration or notification certificate

The medical device registration or notification certificate is valid for five years from the date of issuance. Applications for renewal must be submitted at least 90 working days before the expiration date.

Revision of medical device information

Any changes to the information about a medical device after the registration or notification must be submitted to the FDD for revision within three months from the date such changes are approved in the country of origin.

For medical devices manufactured in the Lao PDR, any changes must be notified to the FDD immediately.

Violation measures

• Any production, importation, or distribution of medical devices without registration or notification with the FDD will be subject to a warning and a fine equal to 100% of the total value of the medical devices.
• Any production, importation, or distribution of counterfeit medical devices will be subject to a warning, confiscation of the medical devices, and a fine equal to 200% of the total value of the medical devices.
• Any distribution of refurbished or reconditioned medical devices without proper authorization will be subject to a warning, confiscation of the medical devices, and a fine equal to 100% of the total value of the medical devices.
• Any importation or distribution of substandard or non-compliant medical devices will be subject to a warning, confiscation of the medical devices, and a fine equal to 200% of the total value of the medical devices.
• Any use or submission of forged or falsified documents for registration or notification of medical devices will be subject to a warning and a fine of LAK500,000 per set of documents.
• Any other violations will be subject to a warning, confiscation of the medical devices, and a fine as determined by the FDD based on the severity of the violation.

Should you have any questions regarding the above decision, or require legal assistance in connection with registration and notification procedures or the classification of medical devices by risk class, please contact the undersigned or your usual VDB Loi adviser.