🔍Workflow for ANATEL Certification
ANATEL certification is essential to ensure that telecommunications equipment in Brazil meets the technical and safety standards set by the National Telecommunications Agency. Before we delve into the certification flow, we recommend that you check out the article “ANATEL Certification: Understand the Process and Its Importance“. This article provides insights into the importance of ANATEL certification for telecommunications devices in Brazil, explaining the process of obtaining the certificate, the technical requirements that must be met, and the benefits of ensuring compliance with ANATEL standards. In addition, the text addresses how certification can help companies avoid penalties and ensure consumer confidence in their telecom products. A step-by-step process is presented below, with indications of possible feedback in the event of problems: 1 – Does the product operate on telecommunication frequencies or emit radio signals? 2 – Selection of a Designated Certification Body (OCD) – Select an OCD authorized by ANATEL, with experience in the product type. 3 – Documentation Preparation – Gather technical specifications, test reports, and other necessary documents. 4 – Certification Request – Fill out forms and pay the fees associated with the certification process through the OCD. 5 – Conformity Testing – Conduct laboratory tests to ensure the product meets ANATEL standards. 6 – Issuance of the Conformity Report – Review the test results and issue the report with the certification decision. 7 – ANATEL Homologation – With a positive conformity report, officially homologate the product with ANATEL. 8 – Certification Maintenance and Renewal – Conduct periodic audits and ensure that quality standards are maintained. 📑 Learn More For a deeper understanding of how the certification process can benefit your company, ensure consumer safety and for more information on medical device certification, contact Brisa’s experts. They are ready to help with your questions and guide you through the certification process. Access now and stay informed about everything! Find out more about BPO in RA! *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br
List of Products That Require INMETRO Certification
Object Product List Compliance Assessment Mechanism Regulatory Body Type of Ordinance Inmetro Ordinance Sterile Hypodermic Needles for Single Use and Sterile Gingival Needles for Single Use Sterile hypodermic needle for single use, Sterile gingival needle for single use Certification Anvisa PAC Ordinance No. 84 of 10/02/2021 Pacifiers Pacifier Certification Anvisa PAC Ordinance No. 301 of 12/07/2021 Equipment under Sanitary Surveillance Regime Equipment under sanitary surveillance regime, including its parts and accessories, for medical, dental, laboratory, or physiotherapeutic purposes, used directly or indirectly for diagnosis, treatment, rehabilitation, and monitoring of humans Certification Anvisa PAC Ordinance No. 384 of 18/12/2020 Single-Use Transfusion Equipment, Gravitational Infusion Equipment, and Infusion Equipment for Use with Infusion Pump Transfusion equipment, Gravitational equipment, Equipment for use with infusion pump Certification Anvisa PAC Ordinance No. 461 of 18/11/2021 Breast Implants Breast implants Certification Anvisa PAC Ordinance No. 5 of 11/01/2022 Surgical and Non-Surgical Procedure Gloves under Sanitary Surveillance Regime, Made of Natural Rubber, and Mixtures of Natural and Synthetic Rubber Surgical gloves made of natural rubber, synthetic rubber, and mixtures of synthetic rubbers; non-surgical procedure gloves made of natural rubber, synthetic rubber, and mixtures of synthetic rubbers Certification Anvisa and MTP PAC Ordinance No. 485 of 08/12/2021 Baby Bottles and Bottle Nipples Baby bottles, Bottle nipples Certification Anvisa PAC Ordinance No. 216 of 06/05/2021
15 Essential Topics for Preparing MD and IVD Manufacturers for ANVISA’s GMP Certification Audit
RESOLUÇÃO – RDC/ANVISA Nº 886, DE 26 DE JUNHO DE 2024
RESOLUTION – RDC No. 591, OF DECEMBER 21, 2021
Technical Note 008/2017-GEGAR/GGGAF/DIGES/ANVISA.
RDC 283/24
NORMATIVE INSTRUCTION – IN N° 290, OF APRIL 4, 2024
As announced last week, ANVISA, at the DICOL meeting, unanimously approved the process of optimized analysis of medical device registration petitions based on analyzes previously carried out by Equivalent Health Authorities. Today (April 8) Normative Instruction No. 290, dated April 4, 2024, was published, with procedures for using analyzes and procedures. Find the legislation for download on our blog at the link below. We will soon have a post with our insights into this new regulation. https://lnkd.in/dXYZjnCv
