The new article provides further clarifications on the applicable regulatory requirements, paying special attention to the most important aspects.
Table of content
ANVISA, a Brazilian regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to personalized medical devices. Structured as a questions-and-answers document, the guidance outlines the key points to be taken into consideration by medical device manufacturers and other parties involved and also provides additional clarifications and recommendations.
At the same time, it is important to mention that provisions of the guidance and recommendations provided therein could be subject to changes, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
In particular, the guidance provides detailed explanations regarding the procedures and requirements for the manufacture and importation of custom-made medical devices based on the relevant regulations.
Consent for Manufacturing or Importing Custom-Made Medical Devices
As described in RDC No. 305, dated September 24, 2019 (revoked by RDC No. 925 on September 19, 2024), the consent to manufacture or import custom-made devices is granted to the requesting company for medical devices in risk classes III and IV, and is specific to the manufacturing facility listed in the Good Manufacturing Practices Certificate submitted with the petition. This consent is linked to a single company and a single manufacturing unit.
Explanation will be as follows:
- Company-Level Consent: Consent is not issued per individual device but is granted to a company that meets all regulatory requirements.
- Manufacturing Unit Specificity: The consent applies only to the manufacturing site specified, ensuring that production adheres to approved standards.
- Risk Classes III and IV: This procedure is mandatory for higher-risk medical devices, reflecting the need for stricter regulatory oversight.
Definition of “Same Intended Use” in Consent Petitions
To submit a petition for consent, the manufacturer must demonstrate technological expertise in producing the device. This requires proof of a valid Anvisa registration for medical devices manufactured on a commercial scale at the same manufacturing unit, with an equivalent risk class and intended use as the custom-made medical device.
This includes:
- Technological Domain Proof: Manufacturers must show they have experience and capability in producing similar devices.
- Equivalent Risk Class and Use: The devices previously registered must match the custom-made device in terms of risk classification and intended medical application.
- Regulatory Compliance: This ensures that manufacturers are competent and comply with existing regulations for similar products.
Regularization of Class I and II Custom-Made Medical Devices
According to the guidance, it is not necessary to submit consent petitions or notifications for the manufacture or importation of custom-made medical devices in risk classes I and II. For these devices, the national manufacturer or importer must maintain a dossier for each device as established in Article 11 of RDC No. 305 (revoked by RDC No. 925).
Additionally, the company must be regularized within the National Health Surveillance System (SNVS), holding an Operating License and Company Operating Authorization (AFE).
Key aspects will include:
- Dossier Maintenance: Companies must keep detailed records for each device but do not need to seek individual consent.
- Regulatory Requirements: Compliance with SNVS regulations, including licenses and authorizations, is mandatory.
- Good Manufacturing Practices: Manufacturers of risk class I and II devices must adhere to the Good Manufacturing Practices outlined in RDC No. 665, dated March 30, 2022.
Eligibility to Request Consent for Custom-Made Devices
As further explained by the authority, only registration holders (national manufacturers and importers) who are regularized before the National Health Surveillance System can request this consent. This includes holding a sanitary license, Company Operating Authorization (AFE), and certification in Good Manufacturing Practices.
Distributors importing through a DDR cannot request consent to manufacture or import custom-made devices and cannot submit notifications for such devices.
In this respect, the authority emphasizes the following:
- Registration Holders Only: Consent is limited to entities officially recognized and authorized by Anvisa.
- Regulatory Compliance: The requirement ensures that only companies meeting strict regulatory standards can produce or import custom-made devices.
- DDR Limitations: Distributors using DDR do not have the necessary authorizations and therefore cannot engage in the consent process for custom-made devices.
Regularization of Patient-Specific Implantable Devices
Under RDC No. 305 (revoked by RDC No. 925), patient-specific medical devices must be regularized through registration or notification, depending on their risk class:
- Risk Classes III and IV: For devices in these classes, a transition period was provided under Article 17 of RDC No. 305 to prevent market interruption.
- Transition Period Measures: During this time, patient-specific devices were treated like custom-made devices, requiring consent and notification procedures.
- Current Requirements: Now, patient-specific medical devices cannot be notified under the previous system and must be fully regularized with Anvisa according to current regulations.
- Manufacture Suspension: Until the device is properly registered, its manufacture must be suspended to comply with regulatory mandates.
Handling Ancillary Components Manufactured Commercially
In cases when a custom-made device requires an ancillary component that is manufactured on a commercial scale, the commercially manufactured ancillary component intended to complement the patient-specific medical device must be regularized.
The company must observe the transition period established in Article 17 of RDC No. 305 (revoked by RDC No. 925), as explained previously in the guidance:
- Regularization of Ancillaries: Ancillary components must be individually registered and comply with all regulatory requirements.
- Transition Period Compliance: Companies should have utilized the transition period to regularize these components.
- No Exceptional Authorizations: The previous practice of case-by-case exceptions is no longer applicable under the current regulations.
- Integrated Systems: Both the custom-made device and its ancillary components must be fully compliant to ensure patient safety and regulatory adherence.
Additional Considerations
- Regulatory Updates: It’s crucial for companies to stay informed about changes in regulations, such as the revocation of RDC No. 305 by RDC No. 925.
- Documentation: Maintaining thorough and up-to-date documentation is essential for compliance, especially for devices that do not require individual consent or notification.
- Risk Management: Manufacturers must perform diligent risk assessments and quality control measures, particularly for higher-risk devices.
Conclusion
In summary, compliance with the applicable regulations for the manufacture and importation of custom-made and patient-specific medical devices is vitally important for ensuring the proper performance of medical devices.
According to the document, such companies must:
- Understand Consent Requirements: Recognize when consent is needed and for which risk classes.
- Demonstrate Technological Capability: Provide evidence of experience and capability in manufacturing similar devices.
- Maintain Regulatory Compliance: Ensure all licenses, authorizations, and certifications are current and meet the requirements of the SNVS.
- Regularize Devices Appropriately: Follow the correct procedures for registration or notification based on the device’s risk class.
- Stay Informed on Regulatory Changes: Keep abreast of updates to regulations to maintain compliance and avoid interruptions in manufacturing or importing processes.
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