The recent Regulations for the Sanitary Control of Medical Devices and Other Devices of Sanitary Interest, issued by the Sanitary Regulation Agency (ARSA), came into effect on December 28, 2023. These regulations aim to establish rigorous standards for the supervision and control of medical devices, ensuring their quality, safety, and effectiveness for the population.
These regulations cover all activities related to medical devices and other devices of sanitary interest, such as:
- Manufacturing and improvement of medical devices.
- Preparation and preservation of products under appropriate conditions.
- Movement of devices across national borders.
- Delivery and sale of devices to the end-user.
- Services related to the operation and leasing of medical devices.
All establishments dedicated to these activities must comply with Good Manufacturing Practices (GMP), Good Storage and Distribution Practices (GDP), Good Laboratory Practices (GLP), among others.
Health License
Establishments must obtain a Health License issued by ARSA. This license is mandatory and must be visibly displayed at the establishment. Additionally, a responsible technical professional must oversee compliance with the regulations.
The categories of establishments include:
- Manufacturers
- Importers
- Warehouses
- Repackagers
- Refurbishers
- Distributors
- Retailers
- Maintenance services
The Health License can be:
- New License: Requires specific documentation, such as a formal application, floor plan, photographs, and internal distribution plan.
- License Renewal: Must be requested at least three months before expiration. Renewal can extend up to six months post-expiration with the payment of a fine.
- License Modification: Required for changes in legal representation, address, trade name, or expanded activities.
Medical Devices and Other Devices of Sanitary Interest
The regulations also classify medical devices based on their risk level. All devices must be registered and approved for sanitary purposes before commercialization. Manufacturers are responsible for ensuring their products meet ARSA’s safety and efficacy standards.
Sanitary Registration
Sanitary registration is mandatory for all medical devices. This process ensures that products comply with the necessary technical and legal requirements for distribution and use in the country. The registration must include:
- Classification of devices based on their potential risk.
- Submission of safety, efficacy, and quality reports.
- Good Practices Certificates: Accreditation of compliance with national and international standards.
Graciela Cruz
graciela.cruz@garciabodan.com
Mananging Partner
García & Bodán
Honduras