Regulatory authority The Central Administration of Pharmaceutical Affairs (CAPA) within the Egyptian Drug Authority (EDA) is responsible for overseeing the regulation of medical devices in Egypt. CAPA has overall responsibility for the evaluation, classification, registration and licensing of locally produced…
The new Medical Device (Duties and Obligations of Establishments) Regulations 2019, which specify the manner, criteria, conditions and procedures of post-marketing activities for medical devices, come into operation on 1 July 20201. The first topic addressed by the Regulations is…
The Medical Device Authority has made a change1 to its Circular Letter No 1 of 2019 concerning the post-market responsibilities of manufacturers and Authorised Representatives who have ceased trading after placing medical devices on the market in Malaysia. The new…
At the 16th management committee meeting of the International Medical Device Regulators Forum (IMDRF), China announced its intention to join the National Competent Authorities Report (NCAR) Exchange Program1. The NCAR Exchange Program facilitates the exchange of relevant post-market safety information…
New guidance has been issued on the requirements for reporting incidents and adverse events involving medical devices (MDS-G39)1. The purpose of this guidance is to specify and clarify the reporting requirements for incidents and events that occur both within the…
The Russian Federation has approved requirements for organising and conducting internal quality control and safety monitoring of medical activities in medical organisations through the publication of Order No 381n, dated 7 June 2019, which was registered by the Ministry of…
In an effort to improve the efficiency of the adverse event reporting process and ensure that medical device incidents are investigated in a risk-proportionate way, the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has revised the process for…
A new draft guidance1 specifies and clarifies the requirements for reporting adverse incidents and adverse events to the Saudi Food and Drug Authority (SFDA) that occur within Saudi Arabia and that are associated with medical devices placed on the Saudi…
The post-market responsibilities of manufacturers and Authorised Representatives who have ceased trading after placing medical devices on the market in Malaysia have been set out in a new policy document1. If an Authorised Representative closes its business after placing a…
On 5 May 2019, the Medical Device Manufacturing Enterprise Supervision Information Platform was put into trial operation1. Initially, 17 provinces will test the platform, and the 14 provinces that already have similar systems will perform data docking test operations. Once…
Comments are being accepted until 10 September 2019 on a proposed update to the document from the International Medical Device Regulators Forum (IMDRF) outlining harmonised terminologies for reporting adverse events related to medical devices, including in vitro diagnostics (IVDs)1. Widespread…
Standardised formats for notifying the Ministry of Health about suspected adverse incidents involving medical devices have been approved through publication of Directorial Resolution No 101-2019-DIGEMID-DG-MINSA on 14 June 20191. Two notification formats have been established: one for reports submitted by…
Regulations have been proposed1 to modify the Medical Devices Regulations and the Food and Drug Regulations in order to operationalise provisions from the 2014 Protecting Canadians from Unsafe Drugs Act, as well as to add certain post-market surveillance provisions for…
The Medical Devices Regulations are to be amended with effect from 16 December 2019 to specify certain medical device incident reporting requirements for hospitals1. The amendment adds the following text to the Regulations after section 61.1: ‘62 (1) For…
Background Following recent safety issues (e.g. with Poly Implant Prothèse breast implants), the European Commission has urged Member States to tighten controls, increase surveillance, and thereby restore full confidence in the European CE marking regulatory system. The key focus areas…
Market overview It is estimated that local manufacturers only meet 10% of the market demand for medical devices in Vietnam, while 90% of medical devices are imported, especially advanced technology like diagnostic imaging equipment. Local manufacturers have only been able…
Additional guidance has been published1 regarding the Medical Device Vigilance System that is currently in operation under the Medical Devices Directives, and which is designed to complement MEDDEV 2.12-1 rev. 8 from 20132. The additional guidance clarifies the existing definitions…
A new Online Safety, Compliance Application and Registration System (OSCAR) is to be launched in June 2019, with full implementation expected three months later, in September 20191. OSCAR will digitise the current reporting process and should allow companies to track…
A number of new guidance documents pertaining to medical devices have been published1 by the Saudi Food and Drug Authority: MDS-G35, Guidance to Implement a Medical Devices Standard ‘Quality Management System’ Regulatory Requirement (ISO 13485:2016) (15 April 2019); MDS-G34,…
Following the amendment of the Medical Device Act on 11 December 2018, the Act’s subordinate legislation, the Medical Device Act Enforcement Regulation, has also been proposed for amendment1. In order to protect against adverse events caused by unintended foreign bodies…
The Therapeutic Goods Administration (TGA) has published an Action Plan for Medical Devices1, which sets out a three part strategy to: improve how new devices get on the market in Australia; strengthen monitoring and follow up of devices already in…
New draft guidance has been issued1,2 that, when finalised, will provide industry with clear information on ways to prepare, plan and work with the Food and Drug Administration (FDA) to ensure voluntary recalls are initiated properly and promptly. The draft…
A new guidance document has been released1,2 as part of the Food and Drug Administration’s (FDA’s) ongoing efforts to strengthen and modernise the process for issuing public warnings about voluntary recalls and for notification of recalls of FDA-regulated products. The…
An immediately-in-effect guidance for industry entitled Compliance Policy for Combination Product Postmarketing Safety Reporting1,2 has been updated. This guidance outlines the Food and Drug Administration’s (FDA’s) compliance policy for Combination Product Applicants and Constituent Part Applicants and activities under Title…
According to Order No 2945/2019, the services and establishments of the National Health Service (Serviço Nacional de Saúde, SNS) may only purchase medical devices that have been coded by the National Authority for Medicines and Health Products (INFARMED) and that…
Introduction Around the world, medical devices have become an integral part of modern healthcare and even daily life. These advancements are largely due to an influx of innovative, digital technology that has changed the medical device environment. Telephones, watches and…
Two new final guidance documents have been published1 by the Saudi Food and Drug Authority (SFDA): MDS-G20, Guidance on Requirements for Clinical Investigations of Medical Devices; and MDS-G30, Guidance on Patient-Matched Medical Devices Using 3D Printers. In addition, eight new draft…
A new Medical Device Enforcement and Quality Report, which was issued in November 2018, shows improvements in compliance rates due to increased device manufacturer inspections and a targeted, risk-based approach by the Food and Drug Administration (FDA)1. The FDA has…
As of 30 January 2019, we are not really any closer to knowing what will actually happen when the UK leaves the European Union (EU) on 29 March 2019. Despite Members of the UK Parliament saying they do not want…
A new version of the Manufacturer Incident Report (MIR) has been published on the European Commission’s website, along with a help document for completing the form correctly1. The new MIR is based on the common terminology developed by the International…
Legislative framework Medical devices are governed by Supreme Decree No 825/98 (Regulations with Control of Medical Use Products and Elements1) and Decree No 725 (the Sanitary Code2). Legislation dates from 1997, when medical devices were included in the Sanitary Code.…
Introduction: The TGA – a small agency with a big footprint Australia’s Therapeutic Goods Administration (TGA) is an internationally respected agency that operates comprehensive regulatory frameworks for medicines, biologicals and medical devices, including in vitro diagnostics (IVDs).The TGA was a…
A Guidance Document for Medical Devices has been drafted1 by the Indian Pharmacopoeia Commission (IPC) to act as a consolidated reference document describing the standards, regulatory and other requirements for medical devices in India. Topics addressed by the draft guidance…
The Food and Drug Administration (FDA) now permits eligible manufacturers to report certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis for certain product codes1, instead of individual 30-day malfunction reports. This alternative reporting option…
The Agency for Medicinal Products and Medical Devices of Serbia (ALIMS) has issued a notice to holders of medical device registrations listed in the Register of Medical Devices to clarify the correct payment of fees (amount and timing) for its…
Consultations are underway on three documents drafted by the International Medical Device Regulators Forum (IMDRF)1: IMDRF Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology structure and codes (consultation closes 12 October 2018) A proposed third edition of document N43,…
The Ministry of Food and Drug Safety has proposed amendments to the Medical Device Act Enforcement Regulation in relation to adverse event reporting1. The proposed changes would clarify the scope of adverse events that should be reported to the Minister…
Towards the end of June 2018, a draft Amendment of the Medical Device Supervision and Administration Regulations was circulated for public comment1. These proposed changes are quite extensive: 12 articles are proposed for addition, two for deletion and 39 for…
A new regulation has been proposed to amend the Medical Devices Regulations in relation to medical device incident reporting by hospitals1. A public consultation on the proposal is now underway. If finalised, the Regulations Amending the Medical Devices Regulations (Medical…
The criteria, methods and conditions for preparing and submitting medical device-related adverse event reports have been published as a Notification in the Royal Gazette and came into effect in Thailand on 4 November 20161. Topics covered in this Notification include…
Revised draft administrative measures on medical device adverse event monitoring and evaluation have been circulated for public comment by the China Food and Drug Administration1. These measures have been amended to strengthen the post-market monitoring of medical devices, standardise the…
A draft regulation for the administration of medical device recalls has been issued by the China Food and Drug Administration to update and strengthen the existing rules in the country1. If finalised, these new rules would, inter alia, increase the…
Medical device manufacturers have been provided with updated guidance in a question-and-answer format on meeting applicable reporting and recordkeeping requirements for certain device-related adverse events and malfunctions1,2. This guidance updates the Food and Drug Administration’s policy and clarifies the Agency’s…
The Center for Devices and Radiological Health’s (CDRH’s) policy for notifying the public about medical device ‘emerging signals’ has been described in a recent guidance document from the Food and Drug Administration1,2. An emerging signal is defined as new information…
Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions have been published by the Food and Drug Administration (FDA) in the form of a final guidance document1,2. This guidance provides clarification for both FDA staff…
The Food and Drug Administration (FDA) has outlined its recommendations for managing post-market cybersecurity vulnerabilities for marketed and distributed medical devices in a new guidance document1,2. The guidance applies to any marketed and distributed medical device, including medical devices that…
Regulations have been published to set out the specific post-marketing safety reporting requirements that apply to combination products in the USA1. These rules apply when two or more different types of regulated medical products (drugs, devices and/or biological products, referred…
At the 39th meeting of the Competent Authorities for Medical Devices (CAMD) in Bratislava, Slovakia, the Joint Action on Market Surveillance of Medical Devices was officially launched, with the UK Medicines and Healthcare products Regulatory Agency taking the lead1. The…
Proposed reforms to the Therapeutic Goods Administration’s (TGA’s) compliance and enforcement approach have been circulated for stakeholder comment1. These proposals would enhance the sanctions and penalties in the Therapeutic Goods Act 1989 and provide the TGA with a wider range…
Legislative amendments have been made1 to improve the transparency and clarity of the standard conditions applied to all inclusions of medical devices in the Australian Register of Therapeutic Goods (ARTG). These conditions relate to storage and transport, recordkeeping, annual reporting,…
