A revision of the Medical Devices Ordinance (MepV) was adopted by the Swiss Federal Council on 25 October 2017 and covered all points arising from the new European Regulations on medical devices and in vitro diagnostics (IVDs) that applied from 26…
As a first step towards implementing the new European Regulations on medical devices and in vitro diagnostics (IVDs), Finland made some amendments to its Law on health care equipment and supplies on 20 December 20171. The amended Law clarifies Valvira’s position as…
The adverse event codes developed by the International Medical Device Regulators Forum (IMDRF)1 are scheduled to be implemented into the European vigilance reporting system from the second quarter of 2018, with a one-year transition period until their official enforcement2. Ideally,…
The Transition Sub Group of the Competent Authorities for Medical Devices has published two frequently-asked-question (FAQ) documents: one on the Medical Device Regulation’s (MDR’s) transitional provisions1 and one on the In Vitro Diagnostic Regulation’s (IVDR’s) transitional provisions2. Each document addresses…
The European Commission has updated1 its manual on borderline and classification issues for medical devices to assist the national Competent Authorities in their decision-making processes. Version 1.18 (December 2017) of the manual includes the following new consensuses on borderline and…
Updated lists of standards harmonised under the Active Implantable Medical Device Directive (90/385/EEC), the Medical Device Directive (93/42/EEC) and the In Vitro Diagnostic Directive (98/79/EC) have been cited in the Official Journal in the form of three Commission Communications1-3. Of…
Directive (EU) 2017/21021 has amended Directive 2011/65/EU2 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (EEE), inter alia, to specify the conditions for the exemption of reused spare parts recovered from EEE. According…
Commission Implementing Regulation (EU) 2017/2185, which was published in November 20171, lists the codes and corresponding types of devices for the purpose of specifying the scope of the designation as Notified Bodies under Regulation (EU) 2017/745 on medical devices and…
The international standard ISO 14971:2007 and its companion guidance ISO TR 24971:2013 are currently undergoing revision and the draft updates have been issued for comment and ballot by the national standards’ committees1,2. The two revised documents are: ISO/CD 14971, Medical…
A draft version of the guidance entitled Optimizing Standards for Regulatory Use has been released by the International Medical Device Regulators Forum (IMDRF) Standards Working Group for public comment until 24 May 20181. The purpose of the draft guidance is…
A proposed document has been released by the International Medical Device Regulators Forum (IMDRF) Personalized Medical Devices Working Group for public comment. The consultation on Definitions for Personalized Medical Devices will close on 24 May 20181. The purpose of this…
A period of public consultation has been held on a new document from the International Medical Device Regulators Forum (IMDRF) entitled Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices(GRRP WG(PD1)/N47)1. When finalised, this new document…
Three guidance documents have been finalised and published by the International Medical Device Regulators Forum (IMDRF) on 27 March 2018. These documents are1: IMDRF/Registry WG/N46 FINAL:2018, Tools for Assessing the Usability of Registries in Support of Regulatory Decision-Making; IMDRF/RPS WG/N13…
Yemen, as well as the six members of the Gulf Cooperation Council (GCC), are holding a period of consultation on a draft GCC Technical Regulation for the restriction of the use of certain hazardous substances in electrical and electronic equipment…
A Draft Uganda Standard covering the chemistry requirements for wrought stainless steel used for the manufacture of surgical instruments has been released for public comment1. The consultation on DUS 1960: 2018, Standard Specification for Wrought Stainless Steels for Surgical Instruments,…
Comments are being solicited until 6 May 2018 on two Draft Uganda Standards (DUSs) on surgical sutures: DUS 1958-1: 2018, Surgical sutures – Specification – Part 1: Absorbable1; DUS 1958-2: 2018, Surgical sutures – Specification – Part 2: Non Absorbable2.…
The United Arab Emirates (UAE), as well as other members of the Gulf Cooperation Council (GCC) and the Yemen, are holding a period of consultation on a draft GCC Technical Regulation for the restriction of the use of certain hazardous…
The Medicines Control Council (MCC) has announced that all manufacturers, distributors and wholesalers of Class A medical devices with a measuring function or that are required to be sterile must apply for a Medical Device Establishment Licence1. Manufacturers, distributors and…
A public consultation has been held during March/April 2018 on proposed amendments1,2 to the Health Products (Medical Devices) Regulations 2010. These proposed amendments take the form of the draft Health Products Act (Amendment of First Schedule) Order 2018, the draft…
Saudi Arabia, as well as other members of the Gulf Cooperation Council (GCC) and the Yemen, are holding a period of consultation on a draft GCC Technical Regulation for the restriction of the use of certain hazardous substances in electrical…
The Saudi Food and Drug Authority has finalised and published eight new guidance documents relating to medical devices1: MDS-G7, Guidance on Medical Devices Bundling Criteria; MDS-G12, Guidance on Importation Requirements for Chemicals Used in Medical Devices Applications; MDS-G13, Guidance for…
Qatar, as well as other members of the Gulf Cooperation Council (GCC) and the Yemen, are holding a period of consultation on a draft GCC Technical Regulation for the restriction of the use of certain hazardous substances in electrical and…
Administrative Order 2018-00021 provides guidelines on the documentary requirements for the registration of medical devices in the Philippines and aligns the country’s registration requirements to the Common Submission Dossier Template (CSDT), which is based on the provisions of the Association…
Oman, as well as other members of the Gulf Cooperation Council (GCC) and the Yemen, are holding a period of consultation on a draft GCC Technical Regulation for the restriction of the use of certain hazardous substances in electrical and…
Consultation has been held on proposed increases to the fees payable1 under New Zealand’s Medicines Regulations 1984 – the first proposed increase in fees since 2006. With respect to medical devices, the cost of a Regulatory Statement to Foreign Government…
The second edition of the guidance document on the requirements for the labelling of medical devices (MDA/GD/0026) has been released1. This updated document is intended to provide advice to manufacturers and Authorised Representatives on the content of medical device labelling.…
Guidance has been published that specifies the requirements for notification of importation and/or supply of unregistered medical devices intended solely for the purpose of demonstration for marketing or for the purpose of education1. The guidance applies to all applicants who…
Original Equipment Manufacturers (OEMs) – companies that produce products that may be sold by other companies – have not been regulated under the Medical Device Act 2012 (Act 737) because they do not fit the definition of a manufacturer or…
Dates have been announced for the implementation and enforcement1 of the requirements specified in the Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combination Products2. For unregistered combination products, the Guideline will apply to new registration applications submitted on…
In March 2018, the Medical Device Authority of the Ministry of Health moved to a new office address1: Level 6, Prima 9, Prima Avenue II, Block 3547, PersiaranApec, 63000 Cyberjaya, Selangor. The operating hours at the new office are the…
Kuwait, as well as other members of the Gulf Cooperation Council (GCC) and the Yemen, are holding a period of consultation on a draft GCC Technical Regulation for the restriction of the use of certain hazardous substances in electrical and…
The 2013 draft revision of SI 60601 Part 2.3, Medical electrical equipment: Particular requirements for the basic safety and essential performance of short-wave therapy equipment, was due to replace SI 1011 Part 2.3. However, the revised standard has not yet been…
According to the minutes of the 78th meeting of the Drugs Technical Advisory Board (DTAB) held on 12 February 2018, certain medical devices are to be added to the list of notified medical devices in India1. The members of DTAB agreed to…
In March 2018, the Ministry of Health and Family Welfare issued a guidance document1 to clarify which medical devices may be grouped into a single licence application under the Medical Devices Rules, 2017. An applicant may group medical devices with…
An updated, English language document addressing frequently-asked-questions1 on the Medical Devices Rules, 2017 has been issued following implementation of the new Rules on 1 January 2018. There are 56 questions and answers in the new document (CDSCO/FAQ/MD/01/2018) from the Central Drugs…
On 21 February 2018, the fees chargeable by registered Notified Bodies for auditing manufacturing sites in accordance with the Medical Devices Rules, 2017 were published by the Drugs Controller General (India)1. These fees have been approved by the Ministry of…
Hong Kong’s Medical Device Control Office plans to conduct a trial to evaluate the feasibility of using Chinese marketing approvals to satisfy the Medical Device Administrative Control System (MDACS) listing requirements1. The trial will last from 1 June 2018 to…
Lists of examples of in vitro diagnostic medical devices (IVDs) that are classified into classes A–D under the Medical Device Administrative Control System (MDACS) have been posted on the Department of Health website1. Each list states that the examples provided…
By 2020, the China Food and Drug Administration intends to establish a robust medical device standards system that meets the needs of medical device supervision in China by offering timely, effective, advanced and applicable standards1. It also plans to prepare…
A number of new technical guidelines have been issued by the China Food and Drug Administration to support and strengthen the supervision and quality of the registration process for medical devices, including the evaluation procedure. These guidelines are as follows:…
Comments have been solicited on a draft guideline from the Centre for Medical Device Evaluation entitled, Guidelines for the Technical Review of Custom Additive Manufacturing Medical Device Registration1. The guidance proposes requirements for the validation and testing of additive manufactured…
Interested parties have until 8 June 2018 to submit comments on China’s Medical Device Unique Identification System Rules (Exposure Draft)1. These draft rules specify the content of a Unique Device Identification (UDI) system for medical devices sold and used in…
In March 2018, the 19th Communist Party of China National Congress approved numerous institutional reforms1 in an effort to improve government efficiency and effectiveness, as well as the allocation of resources. One of these reforms involves merging a number of…
Bahrain, as well as other members of the Gulf Cooperation Council (GCC) and the Yemen, are holding a period of consultation on a draft GCC Technical Regulation for the restriction of the use of certain hazardous substances in electrical and…
A new guidance document has been published by the Therapeutic Goods Administration to clarify the labelling requirements applicable to medical devices containing poisons1. Appendix A of Part 5 of the Poisons Standard lists products that are exempt from the requirements…
Sponsors of Class 1–3 in-house in vitro diagnostics (IVDs) have been provided with guidance1 on how to update their existing notification that has been lodged with the Therapeutic Goods Administration (TGA). The guidance gives step-by-step instructions for using the online…
A number of changes will be made to the Australian regulatory framework for the advertising of therapeutic goods over the next two years1. These changes, which reflect the recommendations of the Review of Medicines and Medical Devices Regulation on reforms…
Speaking at the General Assembly of the Mexican Association of Innovative Industries of Medical Devices, Mexico’s Federal Commissioner for the Protection against Sanitary Risks confirmed that a new medical device classification scheme will allow for the deregulation of 2242 medical…
On 23 May 2018, the National Health Surveillance Agency in Brazil (ANVISA) will launch a new National Implant Registry (Registro Nacional de Implantes, RNI)1. This Registry will be an information system for recording surgical procedures for the implantation of osteoarticular…
According to Guidance Technical Note No 002/2018, dated 6 April 2018, manufacturers of medical devices and/or their accessories that incorporate telecommunication modules must submit certification from the National Telecommunications Agency (ANATEL) as part of an application for listing/registration/modification of an existing…
