On 1 September 2019, the Medical Device Control Office launched a trial scheme to test the feasibility of a streamlined listing application and approval process for Class II/III/IV general medical devices with a proven history of safety and performance1. Only…
With effect from 1 October 2019, the Medical Device Control Office under the Department of Health has been renamed as the Medical Device Division1. The address, telephone and fax numbers remain unchanged. Reference 1. https://www.mdco.gov.hk/english/news/news_20191002.html
Comments are being solicited on a mandatory national standard of the People’s Republic of China concerning ophthalmometers1. This standard specifies the terms and definitions, requirements, and test methods for both continuous and digital indicative ophthalmometers. It is based in part…
New rules for a unique identification system for medical devices have been published (No 66 of 2019) and were implemented officially on 1 October 20191,2. All medical devices sold and used within the People’s Republic of China must comply with these…
China’s Centre for Medical Device Evaluation (CMDE), which operates under the auspices of the National Medical Products Administration, has proposed1 the addition of a number of Class II and Class III medical devices to the Catalogue of Medical Devices Exempted…
Comments are being accepted until 3 November 2019 on a Technical Regulation for Medical Devices and Accessories, which has been drafted by the Ministry of Industry, Commerce & Tourism in coordination with National Health Regulatory Authority (NHRA)1. The purpose of…
Interested parties have until 22 November 2019 to submit comments on whether the Therapeutic Goods (Excluded Purposes) Specification 2010 continues to serve a useful and necessary purpose in prohibiting the supply of certain self-testing in vitro diagnostic medical devices (IVDs)…
Feedback has been sought on proposed changes to the current regulatory requirements for medical device systems and procedure packs1. A system or procedure pack (SOPP) is a package containing therapeutic goods, at least one of which is a medical device…
A period of public consultation has been held on a proposal to revise Australia’s Essential Principles for medical devices in line with international best practice1. Australia’s Essential Principles have not been amended since 2002, except for adding an Essential Principle…
A Ministerial Resolution has been published1 to approve the Technical Document: National Single Request for Essential Medical Devices for the Health Sector (Documento Técnico: Petitorio Nacional Único de Dispositivos Médicos Esenciales para el Sector Salud). This technical document contains a…
Supreme Decree No 018-2019-SA has modified Article 9 of the Regulation for the Registration, Control and Sanitary Vigilance of Pharmaceutical Products, Medical Devices and Health Products, as approved by Supreme Decree No 016-2011-SA, to include Austria as a country of…
All applications for new import permits, as well as for modifications to existing import permits, must now be submitted electronically through the Mexican Digital Window of Foreign Trade (la Ventanilla Digital Mexicana de Comercio Exterior)1. The new rules apply to…
The second revision of Ecuadorian Technical Regulation RTE INEN 049, Natural rubber latex male condoms, has been issued pursuant to Resolution No 19 049 of 26 July 2019 by the Under-Secretariat for Quality of the Ministry of Production, Foreign Trade,…
Three draft resolutions, all dated 16 September 2019, have been proposed to update the minimum requirements for the identity and quality of certain medical devices. Draft Resolution No 7091 proposes a revision of Resolution RDC No 3, dated 4 February…
On 24 September 2019, technical requirements for the manufacturing, marketing, import, export and exposure to use of custom-made and patient-specific medical devices were published in Resolution RDC No 3051. The requirements address, inter alia, Good Manufacturing Practices, labelling, traceability, technovigilance,…
On 24 October 2019, the US Food and Drug Administration (FDA) published another significant update to its list of recognised consensus standards entitled Modifications to the List of Recognized Standards, Recognition List Number: 0521. These standards are intended to help…
A list of prioritised medical device guidance documents that the US Food and Drug Administration (FDA) plans to publish over the next 12 months has been posted on the website of the Center for Devices and Radiological Health (CDRH)1. A…
On 5 September 2019, a discussion paper on assessing the risks for weight-loss devices with varying degrees of benefits was released for public comment1. The concepts discussed in this paper focus on how to consider the extent of weight loss…
Comments are being accepted until 23 December 2019 on a draft guidance containing recommendations for the content and format of certain labelling information for saline and silicone gel-filled breast implants1,2. These recommendations are being made based on concerns that some…
Comments were accepted until 31 October 2019 on the draft guidance entitled, Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment1-3. The purpose of this draft guidance is to set out the Food and Drug Administration’s…
The Food and Drug Administration (FDA) has announced the availability of the draft guidance entitled Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations1,2. This draft guidance is intended to: help sponsors understand how they can…
Guidance has been drafted on Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act1,2. Comments on this draft guidance are being accepted until 25 November 2019. Publication…
Draft guidance entitled the Safer Technologies Program for Medical Devices has been released for public comment1,2. This draft guidance describes a new, voluntary programme for certain medical devices and device-led combination products that are reasonably expected to improve significantly the…
As part of its commitment to strengthening and modernising the 510(k) programme, the Food and Drug Administration (FDA) has issued four draft guidance documents1 and updated a final guidance document2 concerning the Safety and Performance Based Pathway. The four draft…
Numerous guidances have been issued and updated to support the work of the Food and Drug Administration’s (FDA’s) Digital Health Innovation Action Plan and to address key provisions of the 21st Century Cures Act by providing additional clarity on the…
The guidance Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination1,2 describes an optional streamlined submission process for determining whether use of an investigational in vitro diagnostic in an oncology clinical trial under an Investigational…
Guidance has been published1,2 to provide updated recommendations for 510(k) submissions for metal expandable biliary stents and their associated delivery systems to reflect current review practices. These devices are intended to provide luminal patency of malignant strictures in the biliary…
Newly-published guidance addresses labelling considerations for devices containing lubricious coatings used in the vasculature1,2. The guidance provides recommendations for information to be included in the device labelling, as submitted in Pre-Market Approval applications or pre-market notification submissions (510(k)s) for Class…
Guidance entitled Coronary, Peripheral, and Neurovascular Guidewires--Performance Tests and Recommended Labeling has been issued1,2 to update and clarify performance testing and labelling recommendations to support a pre-market notification (510(k)) submission for guidewires intended for use in the coronary vasculature, peripheral…
The Food and Drug Administration (FDA) has finalised a guidance document to clarify to industry and FDA staff the current review practices for the Humanitarian Device Exemption (HDE) programme1,2. An HDE application is the pre-market submission for a Humanitarian Use…
The Special 510(k) Program, which was first established in 1998, has been updated to clarify existing policy, as well as the types of changes appropriate for the Program. The Special 510(k) Program allows manufacturers that are intending to change their…
Updated guidance has been published concerning actions on de novo classification requests and the effects of those actions on the review clock and performance goals1. The guidance describes the different actions that may be taken by the Food and Drug…
The Food and Drug Administration (FDA) has updated its guidance1 on the principal factors it considers when making benefit-risk determinations during the pre-market review process for devices subject to Pre-Market Approval applications (PMAs) and de novo classification requests. It is…
Comments are being accepted until 15 November 2019 on a request to exempt Class II powered wheelchair stretchers from the pre-market notification (510(k)) requirements1. These devices are battery-powered tables with wheels that are intended for medical purposes for use by…
The Food and Drug Administration (FDA) has published the medical device user fees for device submissions and annual fees both for periodic reports and registration of establishments for fiscal year (FY) 2020 (1 October 2019 to 30 September 2020)1. The…
The UK’s exit from the European Union (EU) has been delayed again, this time until 31 January 20201. As the outcome of ‘Brexit’ is still completely unknown, companies are advised to continue planning for a no-deal situation. The Medicines and Healthcare products…
The Health Products Regulatory Authority of Ireland (HPRA) has proposed a general fee increase of 3% for the 2020 financial year plus other the specific changes, citing increased workloads and staffing costs, as well as the challenges posed by Brexit,…
A question-and-answer (Q&A) document on the implementation of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices has been updated by the European Medicines Agency (EMA)1. This first revision focuses on aspects relating…
Following a request from the European Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) has issued a final version of Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which…
A question-and-answer document on the new European identification system for medical devices, which is based on a Unique Device Identifier (UDI), has been issued to provide additional guidance on the topic1. The European UDI system will facilitate easier traceability of…
The second version1 of the Medical Device Coordination Group’s (MDCG’s) questions and answers (Q&A) on requirements relating to Notified Bodies includes extensive additions plus a few minor editorial changes to the original (June 2019) text2. The newly-answered questions are as…
Guidance was published1 in October 2019 by the Medical Device Coordination Group (MDCG) on the qualification and classification of software in Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices. This guidance, which…
A guide for manufacturers and Notified Bodies on the presentation, content and validation of the Summary of Safety and Clinical Performance (SSCP) has been published by the Medical Device Coordination Group (MDCG)1. The guidance outlines general requirements and recommendations for…
The European Commission’s Medical Device Coordination Group (MDCG) has published guidance1 to clarify the transitional provisions of Regulation (EU) 2017/745 on medical devices (the MDR) with respect to the validity of certificates issued under the Medical Devices Directives. Article 120(2)…
A Draft Commission Implementing Decision, which would update the Common Technical Specifications (CTSs) provided for in Article 5.3 of Directive 98/79/EC by amending Decision 2002/364/EC, has been circulated for public comment1,2. The proposal would update the CTSs for certain in…
A draft Commission Implementing Regulation setting out the rules for the application of Regulation (EU) 2017/745 with respect to the Common Specifications for the reprocessing of single-use medical devices has been released1. During the consultation period, which ended on 20…
Commission Implementing Decision (EU) 2019/1396 was published on 11 September 2019 to set out the rules for the designation of expert panels in the field of medical devices1. These expert panels will provide scientific, technical and clinical assistance to the…
In July 2019, comments were solicited on a Project of Guidance on Content of Labelling of Soft Contact Lenses and Contact Lenses Solutions1. The purpose of this draft guidance document is to provide a checklist for the labelling (label and…
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…
During May 2019, three draft guidance documents related to medical device cybersecurity were released for public viewing: Project on Guidance to Pre-Market Cybersecurity of Medical Devices1 This guidance has been designed to help industry identify cybersecurity issues that manufacturers…
