Notification No. 0913-021, dated 13 September 2022, contains updated implementation guidelines for the inclusion of barcodes on containers of certain medical devices, in vitro diagnostics, and consumable materials used repeatedly for medical care exclusively at medical institutions. The updated guidelines…
Ministry of Food and Drug Safety (MFDS) Notification No. 2022-371 (23 August 2022)1 proposes amendments to the Enforcement Rule on the Act on In Vitro Diagnostic Medical Devices. If finalised, the changes would eliminate the need for the manufacturer’s address…
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…
Article 53 of Food and Medicine Administration Proclamation 1112/2019 requires medical devices marketed in Ethiopia to be packed appropriately and contain labelling that is not misleading, does not contain information that is inaccurate, and includes a barcode. Guidelines have been…
The fifth edition of the guidance document MDA/GD/0026, Requirements for Labelling of Medical Devices, was published on 22 June 20221. As the amendments are quite extensive2, the Medical Device Authority has provided a transitional period until 31 December 2022 for…
The National Institute for Drug and Food Surveillance (INVIMA) has informed1 manufacturers and importers of medical devices and biomedical equipment of controlled technology, in vitro diagnostic reagents, and reagents included in Decree 1036 of 2018, that they may notify INVIMA…
Decree No. 111/2021/ND-CP, which came into effect on 15 February 2022, amends and supplements the mandatory labelling requirements found in Decree No. 43 for imported goods and extends its scope to goods exported from Vietnam1. Article 1.5.2 of Decree No.…
A consultation has been held until 28 April 2022 on the fifth revision of MDA/GD/0026, Requirements for labelling of medical devices1. This draft document is intended to provide guidance to manufacturers and Authorised Representatives on the content of medical device…
Regulatory authority The Food and Drugs Authority (FDA) is the government agency responsible for medical device regulation in Ghana in addition to cosmetics, household chemical substances, food, drugs, herbal medicinal products, tobacco, blood and blood products, and the regulation of…
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…
Labellers of soft (hydrophilic) contact lenses have been granted another extension1 to comply with the requirements of the Unique Device Identification (UDI) system established by a 2013 final rule2. The Food and Drug Administration (FDA) had already granted two extensions…
From 1 September 2017, all virtual manufacturers (previously known as own brand labellers) must hold the full technical documentation for any product they place on the market under their name1. Previously, the UK Medicines and Healthcare products Regulatory Agency (MHRA)…
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…
Commission Implementing Regulation (EU) 2021/2226 of 14 December 20211 sets out the rules for the application of Regulation (EU) 2017/745 on medical devices (MDR) with respect to electronic instructions for use. These rules replace Commission Regulation (EU) No 207/2012 by…
Swissmedic has updated Chapter 6 of its leaflet on the obligations of Swiss Economic Operators concerning specification of the manufacturer, the Swiss Authorised Representative (CH-REP) and the importer1. In all cases, without exception, the manufacturer of the product must be…
Manufacturers, companies, distributors, importers and warehouses dealing with all types of medical devices and laboratory reagents are required to apply1 international commodity barcodes (GTIN) to their medical devices that are traded in Egypt, as listed in the electronic MeDevice platform’s…
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…
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…
MDCG 2021-26, dated October 2021, presents Questions and Answers on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/7461. The Medical Device Coordination Group (MDCG) guidance provides answers to frequently asked questions on obligations…
The Spanish Agency for Medicines and Health Products (AEMPS) has extended1 until 30 September 2022 the deadline for amending the labelling and instructions for use of medical devices affected by the European Union (EU)/Switzerland Mutual Recognition Agreement (MRA) ceasing to apply to…
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. 550 of 30 August 20211 establishes the minimum identity and quality requirements for breast implants and the requirement of compliance certification of the product under the Brazilian Conformity Assessment System (SBAC). The Resolution came into force on…
Resolution RDC No. 552 of 30 August 2021 establishes the conditions required for registration, manufacturing, quality control and user information for an intrauterine device (IUD) containing copper1. Chapter II, General Requirements, sets out the specifications for the IUD’s shape, dimensions,…
Changes have been made to Medical device patient information leaflets and implant cards with respect to implantable medical devices excluded from the obligation to provide patient information materials. Version 1.4 of the document, dated August 2021, adds additional devices to…
A partial revision of the Medical Devices Act will come into force on 21 January 2022 (Legal No. 18319), six months after its date of publication1. Among the changes, Article 18-2 will be added to Chapter 3(4) to specify that no-one…
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…
Guidance has been issued to set out the Food and Drug Administration’s (FDA’s) recommendations on testing to assess the safety and compatibility of medical devices in the magnetic resonance (MR) environment and the recommended format for magnetic resonance imaging (MRI)…
A discussion paper has been issued to provide an initial framework to stimulate discussion and to solicit feedback from a variety of stakeholders on how comprehensive information on materials used in devices with long-term exposure could be communicated so that…
From 1 August 2021, all package inserts for medical devices (excluding those for general consumer use) must be made available in digital form instead of paper form1. This change is in line with the 2019 revision of the Act on…
In July 2021, the fourth edition of ISO 15223-1:2021, Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General Requirements, was published1. This fourth edition cancels and replaces the third edition…
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,…
An Implementing Regulation has been proposed to adapt the rules for electronic instructions for use to the new requirements of Regulation (EU) 2017/745 and technological developments in the field1. Following a period of public consultation that ends on 25 May…
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…
In April 2021, a new 72-page standard was published on information to be supplied by the manufacturer with a medical device1. ISO 20417:2021 sets out the requirements for the identification and labels on a medical device or accessory, the packaging,…
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…
With a view to implementing the Medical Devices Act, which was promulgated on 15 January 2020, the Ministry of Health and Welfare has proposed Enforcement Rules of Medical Device Act to provide further details1. The provisions of the draft Enforcement…
A partial revision of the Regulation for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices will be adopted in February 2021 and will enter into force in August 20211. This revision…
The latest version of Medical device patient information leaflets and implant cards (version 1.2, November 2020) re-orders and clarifies some of the information presented in the guidance1. It also adds further detail about timing and presentation of patient implant cards…
The Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morcellators, issued in November 2014, has been replaced by Product Labeling for Laparoscopic Power Morcellators: Guidance for Industry and Food and Drug Administration Staff, dated 30 December 20201,2. This guidance updates…
The relaxed language requirements for the Instructions for Use and labelling of medical face masks, which the Danish Medicines Agency introduced temporarily in August 2020, have been extended by six months1. As a result, it will still be possible to…
Introduction The UK enters a new phase from 1 January 2021, when its Brexit transition period will have ended and UK laws will be independent of those in the European Union (EU), albeit that many will be very similar. Manufacturers,…
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…
A final guidance entitled, Breast Implants – Certain Labeling Recommendations to Improve Patient Communication, has been published by the Food and Drug Administration (FDA)1,2. The labelling recommendations contained in this final guidance are intended to enhance, but not replace, discussions…
The unique properties of nitinol have prompted the Food and Drug Administration to issue new guidance1,2 outlining the specific technical considerations for devices that have at least one patient contacting component comprised of nitinol. The guidance provides clarity and consistency…
New rules have been published1 to make it mandatory for Instructions for Use for registered medical devices to be uploaded onto a publicly accessible section of the National Health Surveillance Agency’s (ANVISA’s) portal. The rules are set out in Resolution…
On 25 August 2020, changes were introduced to the definition of a medical device and other related definitions in the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002. These changes did not, however, include the proposed…
