Version 1 of the Medical Devices Reliance Guideline, SAHPGL-MD-22, was published on 25 February 20261. This guideline outlines the principles and procedures for reliance-based review in both pre-market and post-market regulatory activities for medical devices, including in vitro diagnostics (IVDs). It defines…
Introduction Provision of sufficient clinical evidence is fundamental to demonstrating medical device safety, performance and acceptability of benefit-risk under Regulation (EU) 2017/745 on medical devices (MDR)1. While pre‑market clinical data remain essential to support initial CE marking, they may not…
Comments have been sought on draft Guidelines on the Maintenance of Importation and/or Distribution Records, and the Reporting of Product Complaints, Adverse Events, and Field Safety Corrective Actions for Medical Devices1. The purpose of these Guidelines is to establish requirements…
An updated version of the International Medical Device Regulators Forum (IMDRF) technical document IMDRF/AE WG/N43, Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes, was published on 3 March 20261. The following Annexes to the technical guidance have…
On 23 April 2026, an update was made to the manufacturer incident report (MIR) form (version 7.3.1)1. Use of this updated form becomes mandatory on 1 May 2026 for reporting serious incidents under Regulation (EU) 2017/745 on medical devices and…
In April 2026, Health Canada published new guidance aimed at helping medical device manufacturers comply with key provisions of the Medical Devices Regulations relating to post-market oversight1. The document, entitled Guidance on summary reports and issue-related analyses for medical devices,…
The Medical Device Authority published a guidance document entitled Change Management for Registered Medical Devices for public comment during December 20251. When finalised, this guidance document will replace the existing MDA/GD/0020, Change Notification for Registered Medical Device, and will be…
Why does PMS matter? Medical devices save and improve lives every day. However, no device is risk free. Complications, failures, or unexpected effects can occur in real patients that were not seen during pre-market development. Post-market surveillance (PMS) is the…
At the 29th meeting of the Global Harmonization Working Party (GHWP) in Bangkok, Thailand on 4 December 2025, the following Working Group (WG) guidance documents were endorsed1 according to the simple majority rule: WG1-WG2-WG3, Guidance on Determining of Lead Authority…
In December 2025, MDCG 2025-10, Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices, was published by the Medical Device Coordination Group1. The main objectives of this guidance are: to describe the post-market surveillance (PMS)…
Regulatory authority The primary authority responsible for the regulation of medical devices in Jordan is the Jordan Food and Drug Administration (JFDA), an independent public institution established in 2003. When the JFDA was first established by Provisional Law No. 31…
In September 2025, the Standardised format for post-market surveillance report (PMSR)1 was published to guide manufacturers on what data to include within a PMSR in accordance with The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024. It is…
Introduction This article provides a comprehensive overview of recent regulatory developments in South Africa pertaining to medical devices and in vitro diagnostics (IVDs), as announced by the South African Health Products Regulatory Authority (SAHPRA). One key update involves the phased…
Comments have been sought recently on several proposed documents issued by the Global Harmonization Working Party (GHWP): UDI Application Guidance Considerations for Manufacture to facilitate an effective UDI Implementation1 This document provides an introduction and explanation regarding unique device…
The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 – Statutory Instrument No. 1368 of 2024 – entered into force on 16 June 20251. These Regulations amend the Medical Devices Regulations 2002 by inserting a new Part 4A…
On 16 June 2025, the Medicines and Healthcare products Regulatory Agency published four device specific vigilance guidance documents that provide advice to manufacturers on specific scenarios that should be considered when determining if an incident is reportable: Coronary Stents…
A new version of the manufacturer incident report (MIR) form (version 7.3.1) has been published1. Use of this revised form becomes mandatory in November 2025 for reporting serious incidents under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746…
Introduction The National Drug Authority (NDA) has a mandate to ensure the availability, at all times, of essential, efficacious and cost-effective drugs to the entire population of Uganda, as a means of providing satisfactory healthcare and safeguarding the appropriate use…
Several new technical documents have been published by the International Medical Device Regulators Forum (IMDRF): IMDRF/AE WG/N43FINAL:2025 Updated Annexes (Release No. 2025), Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes (3 March 2025)1 The following Annexes…
On 20 March 2025, the National Agency for the Safety of Medicines and Health Products (ANSM) issued a Guide to Managing Materiovigilance Reports, Reactovigilance Reports, and Safety Notices in Healthcare Facilities1. The objective of this Guide is to outline the…
The Egyptian Guideline for Medical Device Vigilance System 2025 has been the subject of a recent public consultation1. This document sets out the objectives and processes of Egypt’s medical device post-market surveillance and vigilance system, as conducted by manufacturers with…
As of 5 March 2025, the Uniform Recall Procedure for Therapeutic Goods (URPTG) has been replaced by the new Procedure for Recalls, Product Alerts and Product Corrections (PRAC)1. While the PRAC is a complete re-write of the URPTG to improve…
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…
On 21 November 2024, the Center for Devices and Radiological Health launched a communications pilot to enhance the medical device recall programme1. This pilot is intended to improve the timeliness of communications about corrective actions being taken by companies that…
The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 20241 amend the UK’s Medical Devices Regulations 2002 by inserting a new Part 4A on post-market surveillance (PMS) requirements for medical devices, including in vitro diagnostic medical devices (IVDs) and…
Introduction Once a medical device is placed on the market, post-market surveillance (PMS) becomes crucial for identifying any unforeseen issues or risks that may not have been detected during the development phase. This article provides a comparative analysis of PMS…
Introduction Post‑Market Clinical Follow‑up (PMCF) is a continuous process conducted by manufacturers to proactively collect and evaluate clinical data for the medical devices that they have placed on the market. The PMCF process updates the clinical evaluation. With the implementation…
In January 2025, minor changes have been introduced to MDCG 2023-3, Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 and Regulation (EU) 2017/746, via a second revision1: Question 1, Footnote 8 has…
The Therapeutic Goods Administration (TGA) has provided sponsors with advance notice1 of the final package of the recall reforms that will be implemented in early March 2025. This includes providing a preview of Australia’s new recall procedure: the Procedure for…
The Food and Drug Administration (FDA) has made minor, technical modifications1 to the Voluntary Malfunction Summary Reporting (VMSR) programme, which permits manufacturer reporting of certain device malfunction medical device reports in summary form on a quarterly basis. The modifications apply…
On 21 October 2024, the draft post-market surveillance Statutory Instrument was laid in Parliament1. The new regulations will introduce clearer and more robust requirements for post-market surveillance that should improve patient safety. The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great…
Comments have been sought on the draft Mexican Official Standard PROY-NOM-240-SSA1-2024, Installation and operation of technovigilance1, which aims to guarantee the protection of patient health, as well as the safety of medical devices marketed and used in Mexico. The purpose…
MDCG 2024-12, Corrective and preventive action (CAPA) plan assessment: guidance and templates for conformity assessment bodies, notified bodies, designating authorities and joint assessment teams, was released by the Medical Device Coordination Group (MDCG) in October 20241. This guidance document provides…
Regulatory authority The Ministry of Food and Drug Safety (MFDS) is responsible for medical device regulation in the Republic of Korea. It oversees the evaluation, classification, registration, and licensing of all medical devices. It is also responsible for reviewing and…
Introduction MedTech Europe is the trade association for the medical technology industry of medical devices, diagnostics, and digital health technologies that operate in the European market1. Its yearly forum is an insightful event where the latest policy and regulatory developments…
MDCG 2022-4, Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD, has been revised for a second time1, to align it to…
Medical Device Coordination Group (MDCG) 2024-1-5, Guidance on the vigilance system for CE-marked devices – Device Specific Vigilance Guidance (DSVG) 05, Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse Repair and Stress Urinary Incontinence, was published in June 20241. This…
Amendments have been made to the Food and Drug Regulations and the Medical Devices Regulations (MDR) to establish clear obligations for industry when conducting recalls of therapeutic products and to strengthen Health Canada’s oversight of these recalls1. All amendments to…
On 18 July 2024, the Ethiopian Food and Drug Authority posted a new Medical Devices Adverse Event Reporting (MDAER) form on its website for use by healthcare professionals and users1. MDAER is one of the post-market surveillance tools used by…
In January 2024, the Medical Device Coordination Group (MDCG) published Device Specific Vigilance Guidance (DSVG) to harmonise vigilance reporting and provide guidance for manufacturers of specific devices. MDCG 2024-11 provides further clarification on reporting of incidents or serious incidents for…
Version 2.0 of Information sheet IN640_00_001, MDS [Medical Devices Surveillance Division] requirements for corrective and preventive action plans, dated 1 February 2024, represents a thorough revision of the information sheet after completion and evaluation of the test phase1. When deviations…
Version 2.4 of the Uniform Recall Procedure for Therapeutic Goods (URPTG) was published in March 20241. The purpose of this document is to assist Australian sponsors who need to undertake recall and non-recall actions for therapeutic goods in Australia. It outlines…
The first edition of MDA/GD/0067, Medical Device Post Market Information Exchange for ASEAN Member States1, has been published, which is identical to a version ratified at the 12th meeting of the Association of South East Asian Nations (ASEAN) Medical Device…
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…
A reorganisation of Swissmedic, the Swiss Agency for Therapeutic Products, has separated responsibilities for medical device market surveillance from those for medicinal products1. The new Medical Devices Surveillance Sector is responsible for the safety of clinical trials, materiovigilance and market…
In November 2023, Swissmedic revised its information on submitting vigilance reports1 – incidents, trend reports and Field Safety Corrective Action reports – for products according to the Medical Devices Ordinance (SR 812.213) and the Ordinance on In Vitro Diagnostic Medical…
Introduction In Colombia, all medical devices must have a marketing authorisation, which is issued by the National Institute for Food and Drug Surveillance (INVIMA). INVIMA is an institute attached to the Ministry of Health and Social Protection and oversees the…
Resumen En Colombia, todos los dispositivos médicos deben contar con autorización de comercialización (registro sanitario), la cual es emitida por el instituto nacional de vigilancia de medicamentos y alimentos (INVIMA). El INVIMA es un instituto adscrito al Ministerio de Salud…
Introduction The introduction of Regulation (EU) 2017/745 on medical devices (MDR)1 in May 2021 has considerably raised the level of regulatory requirements for the European medical device industry. To continue to CE mark devices across Europe, there are increased expectations…
Provision No. 8194/2023, which was published in the Official Gazette on 3 October 2023, sets out new requirements for Good Technovigilance Practices that will be mandatory for all registration holders of medical products authorised by the National Administration of Medicines,…
