Stakeholders have been given the opportunity to submit comments on a discussion paper on the potential for mandatory reporting of medical device adverse events by healthcare facilities in Australia1. In particular, feedback was sought on the feasibility of mandatory reporting…
Ministry of Food and Drug Safety Notification No. 2021-4941 has set out proposed amendments to the Enforcement Regulations of the Medical Devices Act. On 20 July 2021, the Medical Devices Act was revised to mandate the sealing of medical devices…
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: …
Introduction The medical device industry has been largely unregulated in South Africa with the first medical device regulations introduced in 20161. As such, South Africa is still within the early stages of developing and implementing medical device regulations. The South…
Introduction At one time, there had been a State monopoly on all economic activities in Algeria, including those relating to pharmaceutical products and medical devices. Free healthcare was first introduced in 19741 and the 2018 Health Law continues this through…
Introduction À une certaine époque, il existait un monopole d’État sur toutes les activités économiques en Algérie, y compris celles relatives aux produits pharmaceutiques et aux dispositifs médicaux. La médecine gratuite a été instaurée en 19741 et la loi santé…
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…
Comments were accepted until 28 October 2021 on a Notice of intent1 to amend the Food and Drug Regulations and the Medical Devices Regulations in the spring of 2022 to support regulatory agility. With respect to medical devices, the amendments…
Resolution RDC No. 551 of 30 August 2021 provides for the mandatory implementation and notification of field actions by holders of health product registrations in Brazil1. The registration holder, as well as the other agents involved from production to use…
Full enforcement of the Medical Devices (Establishment Duties and Obligations) Regulations 20191 will begin on 1 July 20222. From this date, any establishment that does not meet its post-market requirements and responsibilities will have its establishment licence and device registrations…
Introduction As the standard of living continues to rise in Thailand and around the world, people continue to demand better healthcare. Better healthcare can come in many forms, from early detection diagnostics utilising artificial intelligence to wearable technology. Heavily relying…
Chinese medical device market The Chinese medical device market is the fourth largest in the world, with a revenue of 800 billion RMB in 20201 and an annual growth rate of around 20%. Although the Chinese government strives for ‘Made in…
The Food and Drug Administration (FDA) has released two draft guidance documents to provide updates on post-approval study (PAS) requirements and post-market surveillance studies. To provide a reasonable assurance, or the continued assurance, of safety and effectiveness of an approved…
On 17 June 2021, the Food and Drug Administration (FDA) qualified the Patient-Reported Outcomes with LASIK [Laser-Assisted In Situ Keratomileusis] Symptoms and Satisfaction (PROWL-SS) through the Medical Device Development Tools (MDDT) programme1. The MDDT programme is a way for the…
On 14 May 2021, the National Health Surveillance Agency (ANVISA) launched a revised and expanded edition of its Manual of Technovigilance: Approaches to the health surveillance of health products marketed in Brazil1. This version of the Manual is more than…
A booklet has been published1 by the National Health Surveillance Agency (ANVISA) to guide manufacturers and importers of medical devices (health products) on field action notifications related to their products. Since 2019, the submission of notification, monitoring and completion of…
In June 2021, the Therapeutic Goods Administration (TGA) released a summary of the responses received to its consultation in late 2020 on proposed enhancements to the adverse event reporting system for medical devices in Australia. The responses and subsequent findings…
Checkpoints for adverse event monitoring carried out by medical device registrants and recorders have been released by the National Medical Products Administration1. These checkpoints are divided into four main categories: institutions and personnel, file management, design and development, and adverse…
Regulatory authority The National Health Regulatory Authority (NHRA) is an independent regulatory body that was established in 2010 by Law No. 38 of 2009. The NHRA’s mission is to regulate the provision of healthcare in Bahrain and ensure appropriateness, continuity,…
The Food and Drug Administration (FDA) has updated1 some adverse event codes, terms, and definitions used in its electronic Medical Device Reporting (eMDR) system to harmonise with the International Medical Device Regulators Forum’s (IMDRF’s) recent update of its adverse event…
In March 2021, the newly revised ‘Regulations on the Supervision and Administration of Medical Devices’ were officially released as State Council Order 739 and will be implemented on 1 June 20211. The new Regulations are split into eight Chapters, with…
Taiwan’s new Medical Devices Act1, which formally separates the regulation of medical devices from pharmaceuticals, is set to take effect on 1 May 2021. The Act defines medical devices as: ‘instruments, machines, apparatus, materials, software, reagents for in vitro…
On 2 March 2021, the International Medical Device Regulators Forum (IMDRF) published a fifth update to its adverse event codes and terms1, which are used in European Union vigilance reporting and in the USA’s electronic Medical Device Reporting system. Edition…
Regulatory authority The Ministry of Health and Prevention (MoHAP) is responsible for the administration of medical device regulation in the United Arab Emirates (UAE). The Ministry oversees evaluation, classification, registration, and licensing of all medical devices, including in vitro diagnostic…
Regulatory changes have been made1 to the Medical Devices Regulations to support implementation of Sections 21.31 and 21.32 of Vanessa’s Law and to provide the Minister of Health with the authority to order medical device licence holders to conduct an…
Regulatory authority The regulatory system for healthcare in the Republic of Peru is not segmented; there is a single national authority for pharmaceutical products and medical devices, including in vitro diagnostic medical devices (IVDs). That authority is the General Direction…
In September 2020, DSVG 05, Insulin Infusion Pumps and Integrated Meter Systems1, was issued as part of the European Commission’s guidance on the vigilance system for CE-marked medical devices. The device-specific guidance provides a non-exhaustive list of examples of what…
The Food and Drug Administration (FDA) has created a new webpage1 to answer questions about adverse event reporting for medical devices distributed under Emergency Use Authorisations (EUAs) or that are the subject of COVID-19 related guidance documents. Each EUA includes…
The Therapeutic Goods Administration (TGA) has established an expedited recall pathway to ensure that faulty or unauthorised COVID-19 devices are quickly removed from the Australian market1. This process will be co-ordinated by the TGA Recalls Section, and recalls will be…
A new post-market review compliance dashboard has been launched1 by the Therapeutic Goods Administration (TGA) to replace the process of responding to a post-market review, and sending associated documentation, via email. The new dashboard, which provides an efficient and secure…
The Therapeutic Goods Administration (TGA) is seeking feedback on five proposed enhancements to the adverse event reporting system for medical devices1. The first proposal is to make changes to the current adverse event reporting exemptions as they may be responsible…
Comments are being accepted until 20 December 2020 on a draft Act on Special Cases Concerning Promoting the Development of Public Health Crisis Response Medical Products and Supplying Medical Products for Emergency Response1. The main points of this draft Act…
Six guidance document revisions have been issued recently by the Saudi Food and Drug Authority (SFDA): MDS-G21, Guidance on Requirements of Shipments Clearance at Ports of Entry, version 4.0, 20 October 20201 The purpose of this guidance is to clarify the…
A new, 43-page guidance has been released1 for manufacturers who are planning and performing their post-market surveillance activities. Other organisations such as importers, distributors and reprocessors who are connected to the manufacturer in the product lifecycle and who play a…
A question-and-answer document on the implementation of the new Manufacturer Incident Report (MIR) form, which became applicable on 1 January 2020, has been published on the European Commission website1. The purpose of this document is to help companies adapt their…
A manufacturer must inform users about any corrective actions involving his device as soon as possible using a Field Safety Notice (FSN). Although there are European guidelines for writing and distributing FSNs in MEDDEV 2.12/1 revision 8, the Medicines and…
On 8 July 2020, a report1 of the Independent Medicines and Medical Devices Safety Review made numerous recommendations for improving patient safety in the UK. The report highlighted the need for substantial reform of the Medicines and Healthcare products Regulatory…
Updates are planned to the Food and Drug Administration’s (FDA’s) electronic medical device reporting (eMDR) system to reflect updates to FDA Form 3500A and other system enhancements1. [FDA Form 3500A is used by manufacturers, distributors, importers and user facilities to…
Ministerial Resolution No. 395-2020-MINSA, published on 17 June 2020, sets out the details of a draft regulation on changes to the health register for medical devices and in vitro diagnostics1. The draft regulation specifies the differences between minor changes and…
New guidance (MDA/GD/0013) on Field Corrective Actions (FCAs) was issued in June 2020 to describe and define the framework for establishing and managing medical device corrective and preventive actions by an establishment1. [Note: FCAs are referred to as Field Safety…
The guidance document MDA/GD/0011, Complaint Handling, was issued in June 2020 to clarify the requirements for handling complaints relating to medical devices1. The guidance applies to all establishments, including exporters, dealing with medical devices as complaints can come from patients,…
New guidance1 explains the requirements for mandatory problem reporting of any incident relating to a medical device as stipulated in Section 40 of Act 737 and Regulation 5 of the Medical Device (Duties and Obligations of Establishments) Regulations 2019. This…
The second version of MDS-G22, Guidance on Medical Device Field Safety Corrective Actions, was published on 8 June 20201. This guidance outlines the requirements and procedures for handling medical device Field Safety Corrective Actions (FSCAs). It applies to manufacturers, Authorised…
Guidance has been published1 on the requirements for medical device recalls as stipulated in the Medical Devices Act 2012 (Act 737) and the Medical Device (Duties and Obligations of Establishment) Regulations 2019. According to the guidance, a recall is ‘any…
A new draft guidance on requirements for reporting and investigation of incidents and adverse events of medical devices specifies and clarifies the requirements for adverse events, incidents, complaints investigation and reporting to the Saudi Food and Drug Authority (SFDA) by…
On 3 March 2020, a new rule on stricter reporting requirements for medical devices came into force to strengthen the monitoring of medical devices1. The Danish Medicines Agency now has the power to impose a more stringent reporting obligation on…
A Notice1 from the National Medical Products Administration, dated 14 April 2020, announces the strengthening of requirements for the inspection of sterile and implantable medical devices, including high value medical consumables. Medical device manufacturing enterprises and users must implement strictly…
Guidance has been drafted to clarify the requirements and procedures for handling medical device Field Safety Corrective Actions (FSCAs)1. There are five main stages to an FSCA that are discussed in the draft guidance: Stage 1: Reporting the FSCA…
Introduction Readers who are well informed in matters concerning Economic Operators (EOs) will be aware that essential parts of the general ‘Goods Package’ were being amended and that these amendments could potentially affect the medical device industry. The Goods Package…
Introduction With a huge population, growing economy, and healthcare aimed at covering 1.4 billion people, China has become the second largest medical device market in the world, averaging a 20% growth rate annually. In 2018, device sales in China reached…
