The Medical Device Authority (MDA) has confirmed1 that approvals issued by the Health Sciences Authority (HSA) of Singapore will be permitted for use in conformity assessments through the verification process, following the successful completion of a six-month pilot programme. Both…
Public feedback is being solicited on proposed changes to the conformity assessment procedures for medical devices1. The consultation period runs from 18 December 2025 to 27 February 2026. The proposed changes are intended to improve the clarity and efficiency of…
Circular Letter of the Medical Device Authority No. 2 of 2025, Policy on Implementation and Enforcement under the Medical Device Act 2012 [Act 737]: Conformity Assessment Procedures for Medical Device Approved by Recognised Countries1, took effect on 30 September 2025,…
The second edition of MDA/GD/0070, Establishment Guide to Medical Device Registration Submission in MeDC@St Through Conformity Assessment by Way of Verification Process for Class A Medical Device Submission and for Class B, C, and D Medical Device Submission via Conformity…
The second edition of MDA/GD/0068, Conformity Assessment Body (CAB) Guide for Conducting Conformity Assessment by Way of Verification, was released in September 20251. This guidance document sets out the requirements for the verification process for Class B, C and D…
An update of the standards used for the sanitary control and verification of the conformity of sterile, single-use hypodermic needles and syringes, as previously established in Ministry of Health Exempt Decree No. 1887 of 27 December 2007, have been published1.…
Public Consultation No. 24, dated 19 August 2025, concerns a proposal1 to amend Inmetro Ordinance No. 5 of 11 January 2022, which approved the consolidated conformity assessment requirements for breast implants. In Annex I (Compliance assessment requirements for breast implants),…
New guidance has been published1 by the Medicines and Healthcare products Regulatory Agency (MHRA) to clarify what the European Union’s (EU’s) extension of the validity of certain Directive 98/79/EC certificates and declarations on in vitro diagnostic devices means for registration…
The Medical Devices (Amendment) (Great Britain) Regulations 2025 will come into force on 24 May 2025 to provide continuity in the regulation of medical devices by maintaining the regulatory status quo1. These Regulations extend to England, Wales, Scotland and Northern Ireland, but…
Circular Letter of the Medical Device Authority No. 1/20251 sets out the policy on Conformity Assessment Procedures for medical devices approved by recognised foreign regulatory authorities for the purpose of registering medical devices under the Medical Device Act 2012 (Act…
A fifth revision of Medical Device Coordination Group MDCG 2019-6, Questions and Answers: Requirements Relating to Notified Bodies, was released in February 20251. MDCG 2019-6 presents questions and answers on requirements relating to Notified Bodies under Regulation (EU) 2017/745 on…
Guidance was published on 6 March 20251 to clarify the new regulatory requirements for medical devices containing medicinal, microbial, recombinant, or animal origin substances that came into effect on 1 July 2024. The new guidance helps sponsors interpret the new…
Regulatory authority The Saudi Food and Drug Authority (SFDA) is responsible for the administration of medical device regulation in the Kingdom of Saudi Arabia. It oversees the evaluation, classification, registration and licensing of all medical devices, as well as medicinal…
Comments are being solicited until 23 December 20241,2 on the following three draft guidance documents which, when finalised, will update the Accreditation Scheme for Conformity Assessment (ASCA) programme: The Accreditation Scheme for Conformity Assessment (ASCA) Program3; Biocompatibility Testing of…
The Estonian Board of Health has updated its procedure for processing conformity assessment exemptions for medical devices and has developed two new application forms1,2. The Board of Health, which is the Competent Authority in Estonia, may exceptionally, on the basis…
A period of public consultation has been held on a new draft guidance document entitled, Regulatory changes for medical devices containing medicinal substances or materials of animal, microbial or recombinant origin – Guidance on the new regulatory requirements and transition…
MDCG 2022-13 Rev. 1, Designation, Re-assessment and Notification of Conformity Assessment Bodies and Notified Bodies, was published in June 20241. Revision 1 of the Medical Device Coordination Group (MDCG) document adds guidance on the conduct of joint assessments relating to…
In May 2024, the Medical Device Coordination Group (MDCG) issued the following templates for preliminary assessments/re-assessments of Notified Body documentation by Designating Authorities: MDCG 2024-6, Preliminary re-assessment review template – MDR (Regulation (EU) 2017/745)1; MDCG 2024-7, Preliminary assessment review…
The Federal Institute for Drugs and Medical Devices (BfArM) has clarified1 that it may exceptionally allow the placing on the market in Germany of medical devices that have not undergone a regular conformity assessment procedure for CE marking if this…
Regulatory authority The Iranian Food and Drug Administration (IFDA) is an independent agency which operates under the Ministry of Health and Medical Education and oversees the evaluation, classification, registration, licensing, and importation of all medical devices. The head of the…
Regulatory essentials Regulatory authority Directorate of Medicines and Pharmacy (Direction du Médicament et de la Pharmacie, DMP) Classification system Medical devices: Classes I, Im (measuring), Is (sterile), IIa, IIb, III In vitro diagnostic reagents: None Registration requirements Application form, administrative…
IMDRF/GRRP WG/N71, Medical Device Regulatory Review Report: Guidance Regarding Information to be Included, was published on 3 February 20231. It provides guidance on the creation of a medical device regulatory review report, which serves as a written record of a…
Comments have been solicited by the South African Health Products Regulatory Authority on the following three guidelines: Guideline for Import Applications of Electronic Devices Emitting Ionizing Radiation1 This guideline sets out the requirements and recommendations when applying for a…
MDCG 2023-2 provides templates1 for Notified Bodies to use to list their standard fees for conformity assessment activities under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). Article 50 of…
Resolution No. 1317/2022 has been published to exclude provisions allowing for the recognition by Conformity Assessment Bodies in Ukraine of conformity assessment results of medical devices, in vitro diagnostic medical devices, and active implantable medical devices carried out by foreign…
In August 2022, the Medical Device Coordination Group (MDCG) published MDCG 2022-13, Designation, re-assessment and notification of conformity assessment bodies and notified bodies1. This guidance document provides advice to the authorities responsible for Notified Bodies and joint assessment teams when…
The Medical Device Coordination Group (MDCG) has released a position paper (MDCG 2022-141) setting out 19 action points that it believes could improve Notified Body capacity and the availability of medical devices and in vitro diagnostics under the new Regulations.…
New guidance1 from the Medical Device Coordination Group (MDCG) outlines the activities to be performed by Notified Bodies as part of their ‘appropriate surveillance’, as defined in the last subparagraph of Article 110(3) of Regulation (EU) 2017/746 on in vitro…
The European Association of Medical Devices Notified Bodies (Team-NB) has recently released several Position Papers to help standardise the approaches taken by Notified Bodies in an effort to improve efficiency and provide more certainty to both Notified Bodies and industry:…
Serbia has clarified1 the conditions and method of recognition of EC certificates of conformity of medical devices due to the transition from the Medical Device Directives to the Medical Device Regulations. If a device’s certificate of conformity (EC certificate) issued…
MP 14: 2022, Methodological procedure on deciding on the introduction of a medical device or an in vitro diagnostic medical device on the market without a conformity assessment according to Article 59 of Regulation (EU) 2017/745 and Article 54 of…
A Resolution has been drafted to exclude provisions allowing for the recognition by Conformity Assessment Bodies in Ukraine of conformity assessment results of medical devices, in vitro diagnostic medical devices, and active implantable medical devices carried out by foreign accredited…
Guidance has been drafted to clarify the Food and Drug Administration’s (FDA’s) expectations for the future use of remote regulatory assessments (RRAs)1,2. RRAs include requests for records and other information for FDA review and interactive evaluations of an FDA-regulated establishment…
An amendment has been made1 to Ministry of Health Exempt Decree No. 93, dated 24 July 20182, which incorporated condoms (including synthetic and natural rubber latex male condoms and female condoms) into the health control regime established in Article 111…
Introduction The UK continues to build its position as a sovereign nation, seeking to be a global leader. The medical technology and in vitro diagnostic (IVD) industries may not be on everyone’s radar, but they are critical, underpinning industries of…
Regulatory authority The Ministry of Health, Drug and Food Control (MoH), through its Pharmaceutical and Herbal Medicines Control and Registration Administration, is responsible for medical device regulation in Kuwait. It oversees the evaluation, classification, registration and licensing of all medical…
Introduction The regulatory framework for medical devices, including in vitro diagnostic medical devices (IVDs), is the set of provisions that make up the technical, legal and regulatory basis that guarantees the safety, efficacy, performance and effectiveness of these products. This…
Introducción El programa regulador para equipos y dispositivos médicos, incluyendo los dispositivos médicos de diagnóstico in vitro (DMDIV), es el conjunto de disposiciones que forman la base técnica, legal y normativa que garantiza la seguridad, eficacia, desempeño y efectividad de…
On 26 June 2022, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published1 its response to the consultation on the future regulation of medical devices and in vitro diagnostics (IVDs) in the UK. The consultation was held between September…
Resolution of the Cabinet of Ministers of Ukraine No 389, On Amendments to Some Resolutions of the Cabinet of Ministers of Ukraine on the Recognition of Conformity Assessment Results of 29 March 2022, entered into force on 30 March 20221. These amendments…
A fifth revision has been issued1 of Appendix 1 to Medical Device Authority Circular No. 2/2014 on the compliance assessment of medical devices that have been approved by recognised country authorities. In Table 1 of Appendix 1 (Recognised foreign regulatory…
Ordinance No. 5 of 11 January 2022, which entered into force on 1 February 2022, approves the consolidated conformity assessment requirements for breast implants1,2. The conformity assessment requirements, and the specifications for the conformity identification seal, for breast implants have…
The German Medical Technology Association (BVMed) has published an English version of the first European Compliance Standard for the medical technology sector1. The new standard contains practical advice and checklists for establishing an adequate compliance setup and offers companies practical…
The Medical Device Authority has announced a policy decision regarding the implementation and enforcement of certain registration and labelling requirements for export-only medical devices1. All medical devices for export only, regardless of their class, are exempt from the conformity assessment…
Both the Australian House of Representatives and the Senate have recommended that the Therapeutic Goods Amendment (2016 Measures No 1) Bill 20161 should receive Royal Assent. When the Bill has been passed and received Royal Assent, it will become an…
INMETRO Ordinance No. 458 of 17 November 2021 has approved the consolidated conformity assessment requirements for sterile, single-use hypodermic syringes and entered into force on 1 December 20211. The conformity assessment requirements and the specifications for the Conformity Identification Seal for…
Since 25 November 2021, new regulatory requirements apply to medical devices that meet the definition of ‘system or procedure packs’ (SOPPs) and are supplied using the special conformity assessment procedure regulatory pathway. New guidance has been issued to assist sponsors…
A fourth revision1 of Appendix 1 to Circular Letter No. 2 of 2014 has been published to amend the table of recognised foreign regulatory authorities and Notified Bodies and the respective approval types eligible for conformity assessment by way of…
Comments were accepted until 2 January 2022 on a draft Law of Ukraine ‘On Medical Devices’, which applies to medical devices, in vitro diagnostic medical devices and active implantable medical devices1. The purpose of the draft Law is to: …
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…
