Central and South America - May 2021

• Argentina: Further extension of exceptions for imported masks, gloves and IR thermometers

• Argentina: Extension of provisional authorisations for critical devices during COVID-19 pandemic

• Argentina: Public consultation on changes to management of certain medical device related procedures

• Bolivia: Presentation of Letters of Legal Representation and Certificates of Good Manufacturing Practice

• Bolivia: Requirements for approval of clinical trials for locally-manufactured lung ventilators

• Bolivia: Sensitivity and specificity requirements for COVID-19 antibody tests

• Brazil: New legal framework for economic monitoring of medical devices comes into force

• Brazil: New procedure for requesting copies of notification and registration processes

• Brazil: Amendments to suspension of compulsory certification rules for medical supplies used in COVID-19 pandemic

• Brazil: ANVISA simplifies the import process to avoid shortages of medical devices during the current public health emergency

• Brazil: ANVISA will have new means of consultation for the rejection of medical devices

• Brazil: Consolidated conformity assessment requirements enter into force for single use sterile hypodermic/gingival needles

• Chile: Guidance on clinical evaluations issued

• Colombia: Depletion of stocks of medical masks authorised under temporary arrangements

• Ecuador: Proposed changes to rules for Good Storage, Distribution and/or Transportation Practices

• Mexico: Guidelines on temporary rules for medical devices to help deal with the effects of the COVID-19 pandemic

• Panama: New rules for Good Storage and Distribution Practices for medical devices and related products

• Peru: New application form for exceptional authorisation of PSA oxygen generators

• Peru: Minor amendment of ‘Regulation of Pharmaceutical Establishments’

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