A new Law on In Vitro Diagnostic Medical Devices (IVDs) was published in the Republic of Korea in 2019 with an implementation date of 1 May 20201. This law defines the necessary matters for the handling, management and support of…
Rules on Supporting Innovative Medical Devices have been drafted and circulated for public comment1. These rules prescribe the procedures and methods for modular review and priority review of medical devices to support the development and commercialisation of innovative medical devices.…
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 (Advertising) Regulations 2019 have been published and come into operation on 1 July 20201. According to the Regulations, no-one may advertise any registered medical device without the approval of the Medical Device Authority. Any contravention of this…
The definitions of orphaned, obsolete and discontinued medical devices have been amended in the second revision of Circular Letter No 2 of 20181. The new text reads as follows: ‘Orphaned medical device means an existing medical device in a…
New guidance (MDA/GD/0018) has been published to clarify the requirements for notification of importation and/or supply of medical devices of all risk classes intended solely for the purpose of demonstration for marketing or education1. The guidance document explains the process…
Three Draft East African Standards (DEAS) relating to surgical sutures and suture needles have been released for public consultation. Comments are being accepted until 7 March 2020; no date of adoption or entry into force has been specified. The three…
New Medical Device Marketing Authorisation (MDMA) fees were set to take effect in Saudi Arabia on 1 December 2019 (04/04/1441 H)1. However, an announcement in December 20192 has postponed the implementation date of these new fees until further notice. …
The third version of MDS-G5, Guidance on Requirements for Medical Device Listing and Marketing Authorization, stated that the use of documentary evidence of compliance with the relevant regulatory requirements applicable in one or more of the jurisdictions of Australia, Canada,…
In December 2019, the Saudi Food and Drug Authority (SFDA) launched a single electronic submission portal (Ghad) to replace the individual registration systems that previously existed for medical devices1. Since 26 December 2019, all applications for Medical Device Marketing Authorization,…
A number of symbols that can be used by manufacturers on product labelling in order to comply with Regulation (EU) 2017/745 on medical devices (MDR) have been published on the International Organization for Standardization (ISO) website as part of the…
Revision 1.3 of GN-34, Guidance Document on IVD [in vitro diagnostic] Analysers, has been circulated for public comment1. The key changes affect: the definitions of ‘accessory’ and ‘in vitro diagnostic (IVD) product’; Change Notifications; Flowchart 4, Product Registration Workflow for…
New Guidelines for Network Security of Medical Equipment for Manufacturing Plants1 have been published in an effort to ensure the cybersecurity of medical devices and their manufacturing facilities. The guidelines recommend that every manufacturing plant should consider cybersecurity-related matters at…
Three Draft East African Standards (DEAS) relating to surgical sutures and suture needles have been released for public consultation. Comments are being accepted until 15 March 2020 (extended from 16 February 2020) with a proposed date of adoption set for…
Notification No 2562 of the Ministry of Public Health was issued in December 2019 to amend the regulations concerning silicone breast implants and to align them with international norms1. Silicone breast implants are considered high risk medical devices as they…
Documentation criteria have been specified for using the new Concise Evaluation route to demonstrate the safety and performance of a medical device as part of the notification/registration process1. Concise Evaluation makes use of marketing approvals from certain ‘reference’ countries as…
On 20 September 2019, the following three Ugandan Standards (US) entered into force: US 1958-1:2019, Surgical sutures – Specification – Part 1: Absorbable1; US 1958-2:2019, Surgical sutures – Specification – Part 2: Non Absorbable2. These two standards specify the…
Vietnam’s Ministry of Health has released a new Decree No 03/2020 (effective 1 January 2020) on the management of medical devices in Vietnam1,2. Decree No 03/2020 has amended and supplemented provisions in Article 68 of Decree No 36/2016/ND-CP dated 15…
The following documents were endorsed as final during the 24th Asian Harmonization Working Party (AHWP) Annual Meeting in Muscat, Oman from 11–14 November 2019: Categorisation of Changes to a Registered Medical Device1 This document provides advice to regulatory authorities…
Five new guidance documents have been published recently by the Saudi Food and Drug Authority (SFDA): MDS-G34, Guidance on Requirements for Unique Device Identification (UDI) for Medical Devices (11 December 2019)1 The purpose of this guidance is to specify the…
IEC 63077:2019, Good refurbishment practices for medical imaging equipment, was published on 13 November 20191. IEC 63077:2019 describes and defines the process of refurbishing used medical imaging equipment without changing the finished medical imaging equipment’s performance, safety specifications, or intended use…
Feedback has been solicited on draft Regulatory Guidelines for Software Medical Devices – A Lifecycle Approach, which are aimed at stakeholders involved in software medical device development and/or supplying such devices in Singapore1. The guidelines are intended to provide clarity…
In December 2019, ISO 14971:2019, Medical devices – Application of risk management to medical devices, was published1. This standard specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro…
Comments were accepted until 3 January 2020 on revision 4.7 of GN-21, Guidance on Change Notification for Registered Medical Devices1. The purpose of this guidance document is to help registrants determine whether a Change Notification needs to be submitted for…
Introduction Generally, borderline products by their nature do not belong clearly to a specific sector and it can therefore be difficult to identify the applicable regulatory framework. When a product does not fall within the definition of a medical device,…
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…
A period of consultation has been held on proposed requirements for Regulatory Authority recognition of Conformity Assessment Bodies conducting medical device regulatory reviews1. The purpose of this draft document from the International Medical Device Regulators Forum (IMDRF) is to define…
Comments are being accepted until 2 December 2019 on the draft Principles and Practices for Medical Device Cybersecurity, which have been developed by the International Medical Device Regulators Forum (IMDRF)1. This draft document sets out fundamental recommendations to all stakeholders…
A high-level competency framework for global medical technology regulators has been drafted1 by the Asian Harmonization Working Party (AHWP) in association with the Asia Pacific Medical Technology Association (APACMed) and Deloitte. The framework structures and prioritises the required competencies for…
Amendments to The Regulations for Governing the Management of Medical Device have been published1 in order to align certain classification descriptions and intended use situations with international standards. Given the nature of some of the changes, a transition period has…
Andrea Julsing Keyter, Deputy Director in charge of medical devices at the South African Health Products Regulatory Authority (SAHPRA) has confirmed that the Authority is on track to initiate the process for registration of medical devices and in vitro diagnostics1.…
A month of consultation has been held on draft Requirements for Registration of Next Generation Sequencing In-vitro Diagnostic medical devices (NGS IVDs)1. This draft document covers the technical requirements for the registration of NGS-based IVDs for germline diseases and tumour…
A list of standards (by category) that will be recognised by the Saudi Food and Drug Authority (SFDA) has been drafted and circulated for comment1. These recognised standards may be used to support medical device pre-market submissions and to satisfy…
Criteria for the bundling/grouping of medical devices, including in vitro diagnostic medical devices (IVDs), within one Technical File Assessment (TFA) application for Medical Device Marketing Authorisation (MDMA) have been drafted1. Single medical devices may be grouped together as a ‘family’…
Guidance has been drafted to outline the requirements of an expedited approval process for innovative medical devices1. In an effort to speed up patient access to innovative medical devices whilst still ensuring their safety and effectiveness, the Saudi Food and…
New guidance has been published to clarify the requirements for electronic instructions for use (e-IFU) for medical devices, including in vitro diagnostic medical devices (IVDs) (MDS-G41)1. Electronic instructions for use may only be used when the device is intended for…
Guidance has been issued on the content of the labelling of soft contact lenses and contact lens solutions (MDS-G40)1. The guidance provides a checklist for the labelling (label and instructions for use) of soft contact lenses and contact lens solutions…
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…
A third version of MDS-G5, Guidance on Requirements for Medical Device Listing and Marketing Authorization, has been published to clarify further the requirements for medical device listing and for obtaining Medical Device Marketing Authorisation (MDMA)1. This guidance applies to manufacturers,…
New Medical Device Marketing Authorisation (MDMA) fees are set to take effect in Saudi Arabia on 1 December 2019 (04/04/1441 H)1. The new fee structure is based on the number of products in an application and not on the risk…
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…
A pilot study is being held to assess the capability of medical device companies to comply with the technical requirements for initial registration of Class B, Class C and Class D medical devices based on the Association of South East…
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…
On 1 July 2019, a new schedule of fees payable under the Medicines Act 1981 came into effect1. The new fee for a medical device Regulatory Statement to Foreign Government (per statement) is NZ$178.25. Reference 1. https://www.medsafe.govt.nz/regulatory/Fees/New%20Fees.pdf
A policy for handling and controlling orphaned, obsolete and discontinued medical devices has been updated by the Medical Device Authority via Circular No 2 of 2018 (Revision 1)1. The original version was published in 20182. For the purposes of this…
In order to promote a reliable supply, and safe management, of medical devices, the Ministry of Food and Drug Safety has proposed two changes1 to the Enforcement Regulation of the Medical Devices Act. Firstly, when supply interruptions become predictable for…
The Ministry of Food and Drug Safety of the Republic of Korea has proposed amendments1 to the Medical Devices Act to address certain limitations identified during operation of the Act. The proposed revisions are as follows: Clarification of the…
Comments are being accepted until 13 December 2019 on a draft technical regulation covering the mandatory implementation of halal product assurance for specific products, including medical devices1. Such products will require a halal certificate issued by the Halal Insurance Agency…
The Ministry of Health and Family Welfare has proposed regulating all medical devices for human and animal use as drugs with effect from 1 December 2019, meaning it will become mandatory for all medical devices to be certified by the…
From 1 October 2019 to 31 March 2020, the Medical Device Division will conduct a trial to evaluate the feasibility of using valid marketing approvals obtained from the Ministry of Food and Drug Safety in the Republic of Korea to…
