The Egyptian Drug Authority has announced that, as of 2 January 2024, companies wishing to obtain import approvals for unregistered medical devices, including but not limited to Class I, non-sterile medical devices, must submit commitment letters from the applicant and…
Circular No. HK.02.02/E/1289/2023 sets out certain requirements relating to post-market testing of medical devices1. Distribution permit holders are expected to carry out post-market testing of products in circulation to ensure they continue to meet their safety, quality and benefit requirements.…
The third revision of GN-05: Guidance on the Reporting of Adverse Events for Medical Devices was released in September 20231. Like the guidances on complaint handling and good distribution practice mentioned in the previous article, a note has been added…
A free, voluntary vigilance programme to support medical device sponsors in complying with their ongoing post-market surveillance responsibilities is being piloted for 12 months1. All Australian medical device sponsors who have an entry in the Australian Register of Therapeutic Goods…
A minor change has been made to medical device guidance GN-07, Guidance on Complaint Handling of Medical Devices (revision 3), dated September 20231. A note has been added to the scope to clarify that medical device dealers should encourage feedback…
Interested parties have been provided with an opportunity to comment on the UK’s proposed Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 20231. When finalised, these Regulations would amend the Medical Devices Regulations 2002 to introduce clearer, risk proportionate…
Introduction Medical devices, along with medicines, are basic elements of any healthcare system. Both medicines and medical devices need to be regulated in order to guarantee their quality, efficacy and safety when used by a patient. In Tunisia, medicines have…
On 16 May 2023, the Finnish Medicines Agency (Fimea) issued a new Regulation 1/2023 and accompanying instructions on the notification of a medical device by a professional user and the handling of a medical device that has been in a…
Consultations carried out by the National Agency for the Safety of Medicines and Health Products (ANSM) with pharmacists who distribute or use medical devices or in vitro diagnostic medical devices show that most of the Field Safety Notices (FSNs) they…
New guidance has been published for manufacturers on reporting adverse incidents involving Software as a Medical Device (SaMD) under the vigilance system1. Any event that meets the three reporting criteria specified in MEDDEV 2.12/1 rev 8 (section 5.1.1.) is considered an…
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…
To clarify important terms and concepts that are outlined in Section 2 (Vigilance) of Chapter VII (Post-market surveillance, vigilance and market surveillance) of Regulation (EU) 2017/745 on medical devices (MDR), the Medical Device Coordination Group has published MDCG 2023-31. This…
Interested parties have until 29 June 2023 to submit comments on proposed changes to the requirements for medical device recalls and establishment licences1. Industry stakeholders have raised concerns that the timelines and expectations for reporting company-initiated (i.e. voluntary) recalls are…
The fourth edition of Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form1 (IMDRF/NCAR WG/N14FINAL:2023) was published in April 2023. This document concerns a confidential communication system between national Competent Authorities on serious public health issues,…
Overview of Mexico Mexico is a country with more than 125 million inhabitants and a wide diversity of medical conditions, most of them chronic and degenerative, such as cardiovascular disease, diabetes and cancer. To understand the Mexican market for medical…
Descripción general del país México es un país con más de 125 millones de habitantes, con una gran diversidad de padecimientos, la mayoría crónico degenerativos, como son las enfermedades cardiovasculares, diabetes, cáncer, entre otros. Para entender el mercado de los…
MDCG 2022-21 has been published1 to provide guidance to manufacturers on implementing the legal requirements for Periodic Safety Update Reports (PSURs) set out in Article 86 of Regulation (EU) 2017/745 on medical devices (MDR). The introduction of the PSUR requirement…
The first revision of MDCG 2022-4, Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR [Medical Device Regulation] with regard to devices covered by certificates according to the MDD [Medical Device Directive] or the AIMDD…
Since 1 December 2022, manufacturers must submit their vigilance reports for medical devices and national medical information systems (NMI) to the Swedish Medical Products Agency (MPA) via an online portal1. The submission of vigilance reports by email is no longer…
The Food and Drug Administration (FDA) has drafted guidance1,2 to help manufacturers better understand and use the Voluntary Malfunction Summary Reporting (VMSR) Program. This draft guidance, which is open for public comment until 7 February 2023, is intended to explain…
On 8 September 2022, Appendix 4 (Field Safety Warnings and End-of-Life notification) was added to the Medicines and Healthcare products Regulatory Agency’s Guidance: Medical device stand-alone software including apps (including IVDMDs)1. This guidance applies to standalone software and apps placed…
Two final guidance documents have been issued1 that are intended to enhance patient safety by facilitating timely initiation and completion of post-approval studies (PAS) and post-market surveillance (PMS) under section 522 of the Federal Food, Drug, and Cosmetic Act (FFD&C…
Guiding Opinions have been issued to help local drug regulatory authorities carry out better supervision of medical device manufacturing and operations under the medical device registration system1. These Guiding Opinions will come into force on 1 January 2023. The Guiding…
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…
A Ministerial Decree has been published to establish a national network for the surveillance of medical devices and to set out details of the information system necessary to support it1. The Decree has implemented a provision stipulated in Law No.…
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…
Use of a specific QR code for reporting medical device related complaints is mandatory according to Circular No. (22) 2022 of 29 June 20221. The QR code, which is illustrated in the Circular, must be placed in a clearly visible…
The first edition of Guidelines for Medical Device Recall was posted on the Ethiopian Food and Drug Authority (EFDA) website in July 20221. These Guidelines provide guidance to medical device manufacturers, Authorised Representatives, importers, wholesalers and other concerned parties on…
Full enforcement of the Medical Device (Duties and Obligations of Establishments) Regulations 2019 began on 1 July 20221,2. All parties involved in the importation, distribution and placement of medical devices on the Malaysian market must now comply with all requirements…
Malaysia’s new Medical Device Centralised Reporting System (MEDCREST) is now operational and ready for use by medical device establishments1. All mandatory problem reporting, field corrective actions and device recalls can be notified online using the MEDCREST system at https://medcrest.mda.gov.my. …
An Administrative Order has been proposed to adopt officially and incorporate the provisions of Annex 5 of the Association of South East Asian Nations (ASEAN) Medical Device Directive (MDD), Post Marketing Alert System (PMAS) Requirements, into the national regulations of the…
Clarification has been provided on the identification information that must be included on a medical device recall incident report form1. According to paragraph 1 of Article 16 of the Measures for the Administration of a Medical Device Recall, if a…
In March 2022, version 1.1 of Reclassification of active implantable medical devices (AIMD) – Guidance on the transitional arrangements and obligations was published1. The purpose of this guidance is to assist sponsors of AIMDs in meeting their regulatory obligations, and…
Towards the end of 2021, stakeholders were given the opportunity to comment on a discussion paper on the potential for mandatory reporting of medical device adverse events by healthcare facilities in Australia1. In total, 56 responses were received from stakeholders…
Non-binding recommendations on the initiation of voluntary recalls under Title 21 of the Code of Federal Regulations (21 CFR) Part 7, Subpart C have been published as final guidance1. The guidance outlines steps companies should take – before a recall…
Comments were accepted until 25 March 2022 on a proposed regulation concerning incident reporting by professional users of medical devices1. The proposal specifies an obligation imposed on a professional user by Section 33 of the Medical Devices Act (719/2021) to…
Introduction The introduction of the European Medical Device Regulation (2017/745, MDR)1 back in May 2021 has considerably raised the level of regulatory requirements across the medical device industry. To continue to CE mark their devices across Europe, there are increased…
Introduction Post-market surveillance (PMS) is a topic of increasing importance in the regulation of medical devices, as recently demonstrated by the significant increase in PMS requirements in the European Union (EU) under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746…
The International Medical Device Regulators Forum (IMDRF) has published a number of new guidance documents, several of which relate to adverse event reporting. The newly-published final documents are as follows1: IMDRF/AE WG/N43FINAL:2017, IMDRF terminologies for categorized Adverse Event Reporting…
In March 2017, the Ministry of Food and Drug Safety in Korea introduced a medical device sales blocking system1 to support the recall of medical devices by particularly targeting distributors that are exempt from the requirements to obtain a Medical…
On 1 May 2017, China’s updated rules for the supervision and management of medical device recalls (Order No 29) came into force1 and superseded the Medical Device Recall Management Approach (Trial) (Ministry of Health Order No 82 of 1 July…
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…
The Medicines and Healthcare products Regulatory Agency (MHRA) has clarified its range of investigatory and enforcement powers with respect to medical devices in the form of updated guidance1. A manufacturer based in the UK who intends to supply medical devices…
Introduction The new Regulation (EU) 2017/745 on medical devices (MDR)1 introduces a paradigm shift for Post-Market Surveillance (PMS)2–4. According to ISO/TIR 20416:20205, six major functions of a medical device’s lifecycle interact with PMS processes, namely design development, clinical evaluation, activities…
Introduction The VietNamese healthcare market is in a time of change as the government seeks to invest in aging facilities and equipment while enticing foreign manufacturers with new, friendlier regulations. Seen as a high potential market, only specific medical devices…
The idea of a common Eurasian medical device market The Eurasian Economic Union (EAEU) comprises Russia, Kazakhstan, Belarus, Armenia and Kyrgyzstan and has a combined population of more than 184 million. In its first five years, the gross domestic product…
A platform that allows rapid searches of national alerts of medical devices and notifications of field actions as part of technovigilance has been launched by the Brazilian National Health Surveillance Agency (ANVISA)1 to strengthen the System of Notification and Investigation…
The Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 has made changes to the Therapeutic Goods (Medical Devices) Regulations 2002 with respect to final reports about adverse events or occurrences for medical devices1. Sponsors must submit a final…
