Brazilian medical device market regulator ANVISA published on September 24th new rules for manufacturing, importing, marketing and vigilance responsibilities concerning custom-made devices. Under ANVISA’s current system, custom-made devices’ applications had to go through a specialized submission process, with no specific Brazilian regulations to serve as reference. RDC nº 305/2019 will come into effect from October 24th, 30 days after the official publication.

The new regulation distinguishes four terms regarding custom-made products and categories: Personalized medical devices (Dispositivo médico personalizado), Adaptable medical devices (Dispositivo médico adaptável), Patient-specific medical devices (Dispositivo médico paciente-específico) and custom-made medical devices (Dispositivo médico sob medida) as detailed above:

Personalized medical devices (Dispositivo médico personalizado): generic term to describe any type of medical devices intended for use by particular individuals, which may be custom-made devices, patient-specific medical devices or adaptable medical devices.

Custom-made medical devices (Dispositivo médico sob medida): intended exclusively for use by particular individuals, and manufactured specifically according to an authorized healthcare professional. The professional is responsible for specific design features, even in cases where a project can be developed in collaboration with the device manufacturer. Such product is intended to meet a specific anatomical or physiological condition or condition of a particular individual.

Adaptable medical devices (Dispositivo médico adaptável): mass-produced devices that undergo adaption, adjustment, fitting or molding based on a manufacturer’s instructions at the point of care to address a patient’s particular anatomic and physiological characteristics before use.

Patient-specific medical devices (Dispositivo médico paciente-específico): devices made compatible to a patient’s anatomy via anatomical reference sizing techniques, or using anatomical features obtained from imaging examinations. They are typically batch-produced through a process that can be validated and reproduced, under the responsibility of the manufacturer even if the project can be developed in collaboration with a qualified healthcare professional.

According to the new regulation, adaptable medical devices and patient-specific medical devices must undergo ANVISA’s regulation according to the criteria established by Resolutions RDC nº 185/2001 and nº 40/2015, and other current regulations. Therefore, these products must comply with regulations previously established for regular products (not custom-made).  Manufacturers and importers of patient-specific medical devices will have twenty-four months to adapt, counting from the date when the new regulation comes into effect.

Custom-made medical devices are subject to pre-market health control through a different mechanism than regular products. This procedure will be done through two steps: the first is a consent that ANVISA issues to the manufacturer or importer to be able to manufacture or import custom-made devices (Anuência à fabricação ou importação); the second is the notification that the manufacturer or importer has to request ANVISA prior to starting the manufacturing or import of each device (Notificação de fabricação ou importação).

According to the resolution, the national manufacturer or importer of custom-made medical devices must be in compliance with the Health Surveillance. Manufacturers and importers of Class III and IV products must file with ANVISA (one-time only) a request for consent to manufacture or import medical device tailored to each manufacturing unit. In order to do that, the product manufacturer needs Good Manufacturing Practices certification valid for the device’s risk class, as well as proof of valid ANVISA registration of devices manufactured on a commercial scale, in the same factory, with the same risk class and indication of use of the custom-made device. The consent request will be reviewed by ANVISA and the decision will be published on ANVISA’s portal and through electronic letter.

After obtaining the consent letter, the consent holder has to notify ANVISA at least 30 days prior to Risk Class III and/or IV custom-made devices’ manufacture or importation. The notification includes information regarding the product, the prescriber and the patient for which the custom product is intended, as well as technical justification for using the custom product instead of existing therapeutic alternatives registered by ANVISA. In addition, the national manufacturer or importer must keep a dossier for each device, including complete product documentation, as well as detailed case description, pathology and justification for the use of a custom-made device. The dossier must be kept filed within the company for a period of fifteen years from the date of manufacture, in case of implantable products, and five years for non-implantable products.

It’s important to highlight that the resolution does not apply to active medical devices, in vitro diagnostic medical devices (IVDs), medical devices for clinical trials, custom-made products tailored by technical orthopedics and footwear manufacturers, and dental prosthesis services provided by qualified professional.

Please let us know if you have any questions or concerns.

Check the full Resolution. (http://www.in.gov.br/en/web/dou/-/resolucao-rdc-n-305-de-24-de-setembro-de-2019-218018815)

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DOMO Salute Team