06.11.12
Technical File Preparation
Once your company’s B-GMP quality system is in place, you must prepare a technical file for submission to ANVISA. Documentation necessary for a technical file includes technical and scientific data regarding device safety, information on your manufacturing process, information on any laboratory tests conducted on your device, as well as device design, materials and functionality data. Proposed labeling and indications for use for the device also must be provided along with the technical file. All documentation submitted to ANVISA must be in Portuguese (Brazil’s official language).
Along with your technical file, a Certificate of Free Sale (CFS) or other device registration certificate from your device’s country of origin must be provided to your BRH. If you cannot provide a CFS from your home market to ANVISA, proof of marketing approval from two other medical device markets along with reasons stating why your product does not yet have clearance or approval in its home market must be submitted. In addition, a letter of authorization to your BRH must be provided. The BRH then submits the registration application and technical file to ANVISA on the company’s behalf for review.
Once your company’s B-GMP quality system is in place, you must prepare a technical file for submission to ANVISA. Documentation necessary for a technical file includes technical and scientific data regarding device safety, information on your manufacturing process, information on any laboratory tests conducted on your device, as well as device design, materials and functionality data. Proposed labeling and indications for use for the device also must be provided along with the technical file. All documentation submitted to ANVISA must be in Portuguese (Brazil’s official language).
Along with your technical file, a Certificate of Free Sale (CFS) or other device registration certificate from your device’s country of origin must be provided to your BRH. If you cannot provide a CFS from your home market to ANVISA, proof of marketing approval from two other medical device markets along with reasons stating why your product does not yet have clearance or approval in its home market must be submitted. In addition, a letter of authorization to your BRH must be provided. The BRH then submits the registration application and technical file to ANVISA on the company’s behalf for review.