The new article addresses aspects related to the regulatory requirements for the importation of medical device accessories, as well as combination products and refurbished medical devices.
The Brazilian regulating authority in the sphere of healthcare products (ANVISA) has published a guidance document dedicated to the importation of medical devices. The document provides an overview of the applicable regulatory requirements as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers, importers, and other 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 to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding changes to the underlying legislation.
Components and Accessories
The existing legislation also provides procedures for the importation of components of medical devices. In particular, the applicable regulations provide that in the case of accessories and parts for medical devices allowed for marketing and use in the country, an interested party will have to provide:
- The registration number for a medical device that an accessory is intended to be used with
- A declaration whereby a registration holder authorizes a third party to import the product in question – in case of import being outsourced;
- Import authorization;
- Other additional documents the authority may require.
As further explained by the authority, all the accessories should be included in the initial registration of a medical device, indicating their names and reference codes.
It is also important to mention that importation could take place even if the registration of the main medical device expires or is canceled. The procedure to be followed in such cases is similar to the one that applies in the case of medical devices with a valid registration. Should such products be imported by a party other than the registration holder, authorization from the registration holder will be required.
A part or accessory subject to importation could be manufactured by an entity, different from the original medical device manufacturer. In such cases, it would also be necessary to provide a declaration to be issued by the original device manufacturer confirming that the accessory in question could be integrated into the original device. According to the guidance, the said declaration should quote the name, model, and registration number of the original device, as well as the name, model, and manufacturer details of an accessory to be imported.
The authority also mentions that accessories and parts are traceable by batch/serial, or part number. This information is mandatory irrespective of the importation purpose for any and all medical devices, accessories, or components thereof, including, inter alia, the ones supplied for replacement.
Kits and Sets
The document also describes the approach to be applied with respect to medical device kits and sets. According to the guidance, such products constitute a commercial unit, the configuration of which should not be changed at the time of importation. In such a case, products should be imported together inside the same secondary packaging, with no further grouping, packaging, or repackaging allowed.
According to the guidance, special rules also apply in the case of combination products comprised of several products that are different in terms of their regulatory nature. For instance, in the case of products having medicines and medical devices in the same secondary packaging, the following rules apply:
- In case of a product being registered as a medicine, while the medical device component does not have the main function, such product should be imported under the medicines framework.
- In the case of a medical device responsible for the primary mode of action of the product in question, general rules for the importation of medical devices will apply.
- The data related to both medicine and medical devices would be subject to validation in the course of the same importation process.
Refurbished and Reprocessed Medical Equipment
The current regulatory framework also provides a set of rules to be applied with respect to refurbished medical devices. These rules apply to the product subject to refurbishment carried out by the original medical device manufacturer or another company authorized to conduct such activities. Under the general rule, refurbishing includes the repair, rework, and replacement of worn parts, as well as the upgrade of software and hardware reasonably necessary to reinstate the proper operations and characteristics of a used medical device. Upon refurbishment, the product should meet the specifications applicable to original, new devices of this type.
For the refurbished medical devices to be allowed for importation, the following requirements should be met:
- The product should be registered, and its registration should be valid.
- The manufacturer indicated in the Import License should be a refurbishing factory unit.
- All refurbished medical devices should be accompanied by additional information about the refurbishing date and changes implemented. This includes affixing a new label. At the same time, the latter requirement will not apply in the case of accessories and components.
According to the guidance, reprocessing covers the cleaning, disinfection, or sterilization process the device is subject to. Under the existing legislation, reprocessing could take place at two levels: intermediate and high.
For both refurbished and reprocessed medical devices, additional importation rules and restrictions apply.
In summary, the present ANVISA guidance provides an overview of the regulatory requirements to be applied in the case of the importation of specific categories of products, such as combination products, medical device kits and sets, and accessories to medical devices already on the market. The document highlights the key points to be taken into consideration and also outlines the details to be included in the submission in order to ensure its completeness in terms of information reasonably necessary for the authority to complete its assessment.
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