Our team has compiled a few important news from the past days concerning medical device’s regulation and the Brazilian regulatory system:

ANATEL – New regulation for Conformity Assessment and Homologation of Telecommunication Products

ANATEL approved on October 17^th, the new Regulations for Conformity Assessment and Homologation of Telecommunications Products.

The new Regulation institutes the end of fee charges for the homologation certificate’s issuance. The exemption from the fee is immediate and valid for all telecommunications products approved by ANATEL.

In the conformity assessment process, the equipment is subjected to verification of technical standards and laboratory tests that seek to ensure that they are properly tested and approved for use in Brazil.

The Regulations to which it refers shall enter into force within 180 days from the date of publication of the Resolution in the DOU (Brazilian Official Gazzete), except in relation to the obligations contained in Title IV and art. 58, concerning, respectively, the Market Surveillance Program and the exemption from the fees, which will enter into force on the date of publication of the new Resolution.

The changes, comparing it to the current regulation, concern the gratuity of the Homologation Fee, the Market Supervision Program, with the collection of samples made by the OCDs or ANATEL, and Certificates of Technical Compliance that will be issued only considering the applicant established regularly in the country.

Also, the Market Surveillance Program – where OCDS will collect samples directly from the market, according to procedure to be defined by ANATEL, came into effect with the publication. OCDs may also have Memorandum of Understanding with foreign Certification Bodies, as long as they are accredited by an accrediting Body recognized by INMETRO / ANATEL.

Petition Analysis Cycle Panel – ANVISA’s new online tool

ANVISA has recently made available on its website the Petition Analysis Cycle Panel, a tool that shows all the steps of the petition process, from the entry in the analysis queue to the moment the registrations and authorizations are finalized.

The purpose is to present, at various levels of analysis, the main stages and life cycle times of petition analysis.  With the aid of the new instrument, companies now have the opportunity to know the average and median deadlines for the granting of product registration and Business Operation Authorizations (AFEs).

ANVISA’s Webinar

ANVISA periodically hosts a Webinar – virtual seminars that bring updated content and knowledge to the public. This week, the Webinar addressed medical equipment’s registration main technical requirements. In addition, ANVISA presented the main reasons for medical equipment’s registration refusal and notification’s cancellation.

The purpose of the seminar was to explain the process of regularization of risk class I and II equipments according to Collegiate Board Resolution (RDC) 270/2019, RDC 40/2015 and Normative Instruction (IN) 22/2017, among other norms and understandings on the subject.

The recording of the seminar and comments made during the transmission are available in portuguese.

“20 years of Medical Device Regulation at ANVISA – next steps”

Registration is now open for participation in the Regulatory Dialogue “20 years of Medical Device Regulation at ANVISA – next steps”. The activity will be held next November 6, in Brasilia. The program of the event includes the discussion of topics such as advances and regulatory perspectives in the country, highlighting the challenges related to custom-made medical devices, software and product’s cybersecurity.

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DOMO Salute Team