Regulatory Newsletter
May Newsletter 2022
EUROPEAN UNION (EU) Stricter rules for placing medical tests on the market | 25 May 2022 From 26 May 2022, new laws for in vitro diagnostic medical devices (IVDR) such as HIV testing, pregnancy...
April Newsletter
AUSTRALIA Transitioning to the new Therapeutic Goods Advertising Code | 05 April 2022 The Therapeutic Goods Administration (TGA) is updating advertisers on the transitional arrangements for the 2021...
March Newsletter
AUSTRALIA Consumer/Patient information materials requirements | 02 March 2022 On 26 October 2017, the Australian government passed laws requiring implanted and active implantable medical devices to...
February Newsletter
EU REGULATIONS MDCG 2022-4 - Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR | 16 February 2022 Article 120(2) and 120(3) of the Medical...
January Newsletter
EU Regulations MDCG 2022-1: Notice to 3rd country manufacturers of SARS-CoV-2 In vitro diagnostic medical devices | 12 January 2022 This notice is addressed to manufacturers of In-Vitro Diagnostic...
December Newsletter
EU REGULATIONS MDCG 2022-4 - Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR | 16 February 2022 Article 120(2) and 120(3) of the Medical...
November Newsletter
EUROPE EUDAMED Notified Bodies and Certificates Module – Relevant documents and information| 15 November 2021 Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in...
October Newsletter
EU REGULATIONS The expert panel in the field of in vitro diagnostic medical devices now accepts submissions from notified bodies for the Performance Evaluation Consultation Procedure | 14 October...
September Newsletter
EU REGULATIONS The expert panel in the field of in vitro diagnostic medical devices now accepts submissions from notified bodies for the Performance Evaluation Consultation Procedure | 03 September...
August Newsletter
EU REGULATIONS Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | 20...
July Newsletter
EU REGULATIONS MDCG 2021-23 – Guidance for notified bodies, distributors, and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU)...
June Newsletter
EU Regulations European Medical Device Nomenclature (EMDN) - Questions and Answers | 15 June 2021 The European Commission (MDCG) published a question and answers article for European Medical Device...
May Newsletter
EU REGULATIONS MDCG Position Paper on the Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers| 27 May 2021 The position paper on the...
April Newsletter
EU REGULATIONS Factsheet for Class I - Medical Devices | 28 April 2021 European commission published a Factsheet for Class I- Medical Devices based on MDCG 2019-5 rev. 1.for class I medical device...
