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ANVISA New Medical Device Regulation RDC 751/2022

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Technical RegulationDocument Title
RDC 185/2001The Registration of Medical products at ANVISA: alteration, revalidation, or cancellation.
RE 1554/2002The risk classification of active devices and electro stimulators for use in physical education, embellishment, and esthetic repair.
RDC 207/2006Amends Resolution No. 185, of 10/22/2001.
RDC 15/2014Good Manufacturing Practice Certification for Medical Device Registration in Brazil.
IN 4/2012Establishes rules for providing instructions for use in non-printed format for Health Products.

 

  1. Medical device risk classification was revised from Rules 1-18 to Rules 1-22. SaMD and nanomaterials are now subject to separate rules (rule 11 and rule 19, respectively). Manufacturers should review the classification of their devices to see whether there have been any changes which require for readjustment. Although the Classes I–IV classification system remains same as before. Additionally, definitions were revised in an effort to comply with the EU Medical Device Regulation (MDR), the IMDRF, and labelling requirements, such as the instructions for use (IFUs). Also updated were the processes for notification, registration, modification, revalidation, and cancellation of the registration of medicinal products.
  2. Every device must have a medical device technical dossier that adheres to the IMDRF’s Table of Contents. Although you won’t need to submit dossiers for Class I and Class II devices to ANVISA, you should be ready in case your files are examined during an audit.
  3. The Documentary Repository of Medical Devices, which will be accessible via the ANVISA electronic site, is another brand-new addition to the scene. Documents pertaining to both notified and registered medical devices are kept in this repository and made accessible through it.
  4. It is necessary to upload the Instructions for Use in specific. The petition and uploading of the Instructions for Use must be completed within 30 days of the publication in the Official Gazette of the Union for medical devices that are being notified, registered, or for devices that are currently on the Brazilian market but have undergone a reportable change.
  5. The time frame is 180 days for non-reportable changes to devices that have previously been registered or notified, as well as for changes to the Instructions for Use.
  6. Activities related to notification and registration are the owner’s duty and are completed by them. The function previously known as “importer” is now known as the “Brazil Registration Holder” (BRH) in the new legislation.
  • By February 28, 2024, manufacturers of Class I or Class II medical devices (with an existing Cadastro) that have been upgraded to Class III or IV must apply for the Registro. As a reminder, Brazilian-based manufacturers and foreign businesses that hold Brazil Registration Holders (BRH) must also seek for certification under Brazilian Good Manufacturing Practises (B-GMP).
  • To change their device risk classifications, manufacturers of Class III or Class IV medical devices (with an existing Registro) need to submit a rectification petition to ANVISA.
  • When submitting their next renewal or modification, manufacturers of Class III or Class IV medical devices (with an existing Registro) should adjust their risk classifications if the device’s classification changes from Class III to Class IV or from Class IV to III. However, in order to alter the device classification, the maker or BRH must submit a modification to the B-GMP.

What does this mean to you?