The new article addresses aspects related to the way eligibility for registration should be determined.
The Brazilian regulating authority in the sphere of medical devices (ANVISA) has published a guidance document dedicated to the importation of medical devices intended to be marketed and used in the country, or for any other purpose. The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by the parties involved in order to ensure compliance. At the same time, provisions of the guidance are non-binding in their legal nature and are not intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes thereto, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
In order to assist medical device manufacturers, importers, and healthcare institutions in complying with the applicable regulatory requirements, the document outlines the scope of products subject to regulation under the medical devices framework.
Medical Devices: Concept
When defining a medical device, ANVISA refers to the definition provided by the International Medical Device Regulators Forum (IMDRF) which is based on the intended purpose of the product in question and the way the purpose is achieved (intended action). Similar definitions are incorporated into the local regulations dedicated to medical devices. The authority additionally emphasizes that any product subject to regulation as a medical device should not be imported into the country before the appropriate approval is granted by the authority.
At the same time, it is important to mention certain exemptions that apply when determining the scope of products subject to regulation as medical devices. According to the guidance, some products could be exempted from registration as medical devices even though they fall formally within the scope of the respective definition. These exemptions could be based on two factors, namely, the intended use of the product as indicated by the original manufacturer and the purpose of importation. For the first question, the authority has already developed and published a list of medical devices that are not subject to regulation under the existing framework. The list is available online. The second exemption applies in the case of products intended for clinical or scientific research involving human beings, technology testing, quality control, teaching and training, and also events and exhibitions. At the same time, importation under this exemption could be subject to special instructions and procedures to be communicated by the authority. In particular, the authority has already developed and published a guidance document dedicated to the importation of products subject to exemption.
The document also outlines the scope of information the authority expects the parties responsible for medical devices to provide when applying for registration with ANVISA and importation permission. As it was mentioned before, medical devices could be imported as raw materials, inputs, bulk, semi-finished, and finished products. When supplied separately, inputs, raw materials, bulk, and semi-finished products are considered components for manufacturing or replacing medical devices. The existing legislation provides an exemption from Authorization to Operate (establishment license) for companies that operate exclusively in the sphere of manufacturing, distribution, storage, packaging, export, transportation, or import of raw materials, components, and inputs that are intended for manufacturing medical devices. In such cases, imported products should meet certain criteria, so the importers will not require the appropriate establishment license. These criteria include, inter alia, the following:
- It should be a Brazilian manufacturer involved in the process.
- The registration number of the import should be indicated on the import form and documentation for the finished medical device that will have the component as a constituent.
- If the registration of the medical device is not in the importer’s company name, a Declaration of the Holder of the Registration of the Product is required for the proper authorization of a third party.
The authority also mentions special procedures and requirements for the importation of raw materials and components for in vitro diagnostic medical devices.
Importation of finished medical devices should be conducted in accordance with the respective procedures by the companies holding the appropriate establishment licenses or be outsourced to third parties holding such licenses. At the same time, healthcare institutions are allowed to import finished medical devices, as well as replacement parts and accessories thereto, for their internal purposes without the need for an establishment license since the appropriate exemption applies.
According to the guidance, a commercial model stands for a version or variation of a medical device intended to be registered in the country. Depending on the type of medical device in question, models could be grouped into families, systems, or sets. In this respect, the authority emphasizes the following:
- Only models covered by the registration scope could be imported.
- The products intended to be exported are exempt from registration with ANVISA; consequently, any components imported for manufacturing such products are exempt from registration as well.
- Medical device models that are still in the process of registration are not allowed for importation before the registration is completed.
- Any discrepancies in codes, references, descriptions, or measurements of models in comparison to the ones reflected in the initial registration are not allowed.
According to the guidance, all commercial presentations and claims made by the manufacturer with respect to the functionality and effectiveness of the device should be verified in the course of registration. It is also necessary to provide information about dimensional variations for the system components.
In summary, the present ANVISA guidance outlines the scope of products subject to registration as medical devices under the existing regulatory framework. The document also highlights the key points regarding the information an applicant should provide when applying for registration of the product and permission for import.
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