Commission Recommendation (EU) 2021/1433 of 1 September 2021 sets out the revised rules for conformity assessment and market surveillance procedures for medical devices and personal protective equipment within the context of the COVID-19 pandemic1. Market surveillance authorities may authorise medical…
The Agency for Medicines and Medical Devices of Serbia (ALIMS) has set out1 the conditions and manner of recognition of foreign compliance documents (CE certificates and Declarations of Conformity) as part of its efforts to harmonise Serbia’s national legislation to…
Updated essential safety and efficacy requirements applicable to health products, excluding in vitro diagnostic medical devices, came into force on 1 October 2021 through publication of Resolution RDC No. 546 of 30 August 20211. This Resolution transposes Mercosur Resolution/GMC/Res. No.…
Resolution RDC No. 549 of 30 August 20211 establishes the procedures for compulsory certification of equipment under the health surveillance scheme, including medical, dental, laboratory or physiotherapy equipment, used directly or indirectly for diagnosis, treatment, rehabilitation and monitoring in humans,…
On 18 August 2021, a correction was issued1 to the National Institute of Metrology, Quality and Technology (INMETRO) Ordinance No. 266 of 22 June 20212, which approved the consolidated conformity assessment requirements for male natural rubber latex condoms. Ordinance No.…
Resolution RDC No. 554/2021, which was published on 31 August 2021, establishes the minimum requirements for the production of natural rubber latex male condoms1. These new requirements, which came into force on 1 October 2021, adopt Mercosur/GMC Resolution 10/08 and…
With effect from 1 October 2021, Resolution RDC No. 539 of 30 August 2021 establishes the minimum identity and quality requirements for single-use transfusion, gravitational infusion and infusion use equipment for use with an infusion pump1. Topics addressed include conformity…
The minimum identity and quality requirements for hypodermic needles and gingival needles have been established through Resolution RDC No. 540 of 30 August 2021, which came into force on 1 October 20211. Excluded from the scope of this Resolution are needles…
Ordinance No. 385 of 17 September 20211 has amended INMETRO Ordinance No. 84 of 10 February 2021, which approved the consolidated conformity assessment requirements for sterile hypodermic needles for single use and sterile gingival needles for single use2. Under the amendment, manufacturers…
Resolution RDC No. 541 of 30 August 2021 establishes the minimum identity and quality requirements for single-use, sterile hypodermic syringes made of plastic and intended for fluid aspiration or fluid injection, performed manually or by syringe pump1. The scope of…
With effect from 1 October 2021, Resolution RDC No. 547 of 30 August 2021 has established the minimum identity and quality requirements for surgical gloves and gloves for non-surgical procedures of natural rubber, synthetic rubber, a mixture of natural and…
Resolution RDC No. 555, dated 30 August 20211, establishes the framework for the limulus amoebocyte lysate (LAL) reagent within the technical regulation on medical products (Resolution RDC No. 185/2001). This Resolution entered into force on 1 October 2021. An LAL…
Decree 42 (exempt) incorporates portable automatic external defibrillators into the sanitary control system1 established in Article 111 of the Sanitary Code and its regulations, approved by Decree No. 825 of 1998. This change will take effect on 17 March 2022.…
Draft Ecuadorian Technical Regulation PRTE INEN No. 262, Assistive products for walking, has been withdrawn and is therefore null and void1. This draft Technical Regulation, which established the requirements to be met by assistive products for walking prior to the…
The Australian Government has repealed Regulation 4.1 and amended Regulation 5.3 of the Therapeutic Goods (Medical Devices) Regulations 2020. Therefore, since 28 July 2021, medical devices that contain medicines or materials of animal, microbial, recombinant or human origin, as well…
On 15 September 2021, changes were made to the Medical Devices Essential Principles Checklist1. These changes included adding clauses relating to personalised medical devices and improving usability. Reference 1. https://www.tga.gov.au/form/essential-principles-checklist-medical-devices
The National Institute of Metrology, Quality and Technology (INMETRO) Ordinance No. 384 of 2020 updated the conformity assessment requirements for certain medical equipment under health surveillance with a six-month transition period1. In June 2021, Ordinance No. 384 of 2020 was…
Ordinance No. 266 of 22 June 2021 approves the consolidated conformity assessment requirements for male natural rubber latex condoms1. Detailed conformity assessment requirements and the specifications for the Conformity Identification Seal for male condoms are set out in Annexes I…
Since 1 July 2021, an Australian company can apply to become an Australian Conformity Assessment Body (CAB) for medical devices1. The determination of an Australian CAB requires demonstrated competency and recognition for undertaking medical device product assessments and quality management…
Pre-clinical testing documents do not need to be submitted for the following eight medical devices under certain circumstances: infrared ear thermometers, electronic thermometers, surgical covers, surgical gowns, infrared forehead thermometers, surgical lamps, electrostatic devices, and infrared lamps (therapeutic devices)1. Instead,…
Royal Decree No. (M/54) has approved the new Medical Devices and Supplies System Regulation1, which will eventually replace the Medical Devices Interim Regulation. The following activities are subject to the provisions of the new Regulation: designing and manufacturing of…
On 1 July 2021, the final version of the International Medical Device Regulators Forum’s (IMDRF’s) Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews was published on its website1. The purpose of…
Ordinance No. 84 of 10 February 2021, which approves the consolidated conformity assessment requirements for sterile hypodermic needles for single use and sterile gingival needles for single use, came into force on 1 March 20211. The conformity assessment requirements, and…
The Department of Health and Family Welfare has issued a proposal1 to allow American Standard Test Methods (ASTMs) to be used for demonstrating conformity to the requirements of the Medical Devices Rules, 2017. According to the current Rule 7 of…
Comments have been sought on a proposed final draft document from the International Medical Device Regulators Forum (IMDRF) Good Regulatory Review Practices Working Group entitled, Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device…
The 2018 guidance document1 outlining the process for obtaining designation for priority review of either Therapeutic Goods Administration (TGA) conformity assessment, or inclusion in the Australian Register of Therapeutic Goods (ARTG), has been updated2. The latest edition (version 2.0) updates…
New guidance1 has been provided to manufacturers on completing and submitting a Declaration of Conformity for Class I non-sterile, non-measuring medical devices, Class 1 in vitro diagnostic medical devices (IVDs) and Class I systems and procedure packs. The process by…
The National Institute of Metrology, Quality and Technology (INMETRO) Ordinance No. 384, which became effective on 28 December 2020, updates the conformity assessment requirements for active medical equipment under health surveillance1. A transition period of six months applies. After this…
In response to the ‘exceptional and unforeseen circumstances’ caused by COVID-19, the European Commission has published a Notice1 on the application of Sections 2.3 and 3.3 of Annex IX to Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU)…
As a result of a legal revision, Swissmedic has updated its information leaflet1 on the options for placing on the market and use of non-compliant medical devices, and medical devices for which the Swiss language requirements are not met. Medical…
New guidance has been issued1 for Notified Bodies on the use of Medical Device Single Audit Program (MDSAP) audit reports in the context of surveillance audits carried out under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746…
The Food and Drug Administration has published1 three final guidance documents on the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program, which describe the goals, scope, procedures, and framework for the voluntary Pilot and provide information about two groups of…
Ordinance No. 289 of 4 September 2020 amends the conformity assessment requirements stated in three Ordinances affecting single-use devices1. Annex A to Ordinance No. 289 amends Ordinance No. 501 of 29 December 2011, which approves the conformity assessment requirements for…
The definitions for system or procedure packs in section 41BF of the Therapeutic Goods Act 1989 have been amended to reflect the new definitions in the Therapeutic Goods Amendment (2020 Measures No. 1) Act 20201 (see Table 1). Table…
Guidance has been issued1 to sponsors and, where relevant, manufacturers on the general approach being taken by the Therapeutic Goods Administration (TGA) with respect to the lapsing of conformity assessment documents due to audit delays caused by COVID-19 and the…
A new guidance document (MDA/GD/0023)1 specifies the requirements for registration of a Conformity Assessment Body (CAB) with the Medical Device Authority as set out in the Fourth Schedule of the Medical Device Regulations 2012 to conduct conformity assessment as prescribed…
Commission Implementing Regulation (EU) 2020/666 was published on 19 May 20201 to amend Implementing Regulation (EU) No 920/2013 on the renewal of designations and the surveillance and monitoring of Notified Bodies. The deferral of the date of application of Regulation…
In May 2020, the Brazilian Health Regulatory Agency (Anvisa) published an Information Note to clarify what lung ventilators are, how they work, and the actions taken by Anvisa to facilitate access to them in the context of COVID-191. Anvisa has…
The Medicines and Healthcare products Regulatory Agency (MHRA) has clarified its position regarding the validity of CE certificates issued under Directives 93/42/EEC, 98/79/EC and 90/385/EEC if a Notified Body closes or its scope of designation is reduced1. The MHRA’s provisions,…
A public consultation is being held until 26 May 2020 on IMDRF/GRRP WG (PD1)/N63, Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews1. This document specifies competence and training requirements that should…
A period of consultation has been held on proposed requirements for Regulatory Authority recognition of Conformity Assessment Bodies conducting medical device regulatory reviews1. The purpose of this draft document from the International Medical Device Regulators Forum (IMDRF) is to define…
The second version1 of the Medical Device Coordination Group’s (MDCG’s) questions and answers (Q&A) on requirements relating to Notified Bodies includes extensive additions plus a few minor editorial changes to the original (June 2019) text2. The newly-answered questions are as…
In June 2019, the Therapeutic Goods Administration (TGA) released new guidance1 on the Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 20192. The 2019 Order specifies relevant conformity assessment standards for medical device Quality Management Systems (QMSs), and…
In June 2019, three new documents were released by the European Commission’s Medical Device Coordination Group (MDCG) to support implementation of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices: MDCG 2019-6,…
Two new final guidance documents have been published1 by the Saudi Food and Drug Authority (SFDA): MDS-G20, Guidance on Requirements for Clinical Investigations of Medical Devices; and MDS-G30, Guidance on Patient-Matched Medical Devices Using 3D Printers. In addition, eight new draft…
As of 30 January 2019, we are not really any closer to knowing what will actually happen when the UK leaves the European Union (EU) on 29 March 2019. Despite Members of the UK Parliament saying they do not want…
Introduction: The TGA – a small agency with a big footprint Australia’s Therapeutic Goods Administration (TGA) is an internationally respected agency that operates comprehensive regulatory frameworks for medicines, biologicals and medical devices, including in vitro diagnostics (IVDs).The TGA was a…
A Guidance Document for Medical Devices has been drafted1 by the Indian Pharmacopoeia Commission (IPC) to act as a consolidated reference document describing the standards, regulatory and other requirements for medical devices in India. Topics addressed by the draft guidance…
The Therapeutic Goods Administration (TGA) intends to expand the range of international assessments and approvals from comparable overseas regulators that sponsors may provide when submitting their applications for inclusion of medical devices in the Australian Register of Therapeutic Goods (ARTG)1.…
Introduction Notified Bodies (NBs) are the entities responsible for assessing and granting certificates for the majority of medical devices and in vitro diagnostics (IVDs) placed and distributed in the European market and beyond. The new Medical Device Regulation (EU) 2017/745…
