A period of public consultation is being held until 30 September 2019 on draft recommendations for manufacturers of medical devices integrating software to ensure that cybersecurity is taken into account during product development to minimise the risk of cyber-attacks1. This…
The application of Regulation (EU) 2017/745 involves new working methods for the Competent Authorities and the Ethics Committees of the Member States with respect to clinical investigations. Therefore, the National Agency for the Safety of Medicines and Health Products (ANSM),…
A list of four issuing entities designated to operate a system for assignment of Unique Device Identifiers (UDIs) pursuant to Regulation (EU) 2017/745 on medical devices and a system for assignment of UDIs pursuant to Regulation (EU) 2017/746 on in…
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 1.22 of the manual includes the following new consensuses on borderline and classification issues:…
Public consultation is being held until 31 August 2019 on a draft Guideline on the quality requirements for drug-device combinations1 developed by the European Medicines Agency (EMA). The guideline provides advice on the documentation expected for drug-device combinations (DDCs) in…
Regulation (EU) 2017/745 on medical devices requires the use of new symbols but EN ISO 15223-1:2016, Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (corrected March…
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…
In June 2019, three new documents were released by the European Commission’s Medical Device Coordination Group (MDCG) to support implementation of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices: MDCG 2019-6,…
A new law has been drafted1 On some amendments and additions to Law No 89/2014 ‘On Medical Devices’. This draft law establishes the procedure for the registration of medical devices, selection of applicants, application procedures for registration, distribution, medical device…
The closing date for comments on the World Health Organization’s (WHO’s) draft policy on remaining shelf-life of medical products is 5 May 20191. Once these comments have been reviewed and discussed, a revised text will be prepared and re-circulated for…
In February 2019, the second editions of ISO 11607-1:2019, Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems1, and ISO 11607-2:2019, Packaging for terminally sterilized medical devices – Part 2: Validation…
Three proposed documents have been released by the International Medical Device Regulators Forum’s (IMDRF’s) Medical Devices Clinical Evidence Working Group1. Consultation on the following drafts closes on 5 June 2019: Clinical Evaluation This draft document provides guidance to manufacturers on…
On 20 March 2019, the final version of the Assembly and Technical Guide for IMDRF [International Medical Device Regulators Forum] Table of Contents [ToC] Submissions was published1. This 20-page guide is intended for use in the assembly of IMDRF ToC…
According to an Interim Report1 on the work of the Executive Working Group dated 30 January 2019, the European Union (EU) and the USA will cooperate to ensure alignment of electronic database specifications for Unique Device Identifiers (UDIs) and will…
The rules governing the marketing of medical devices in Vietnam, especially imported devices, have become stricter following the publication and coming in to force of Decree No 169/2018/ND-CP on 31 December 20181. Under the previous rules, risk classification decisions from…
On 26 March 2019, the following Draft Uganda Standards (DUSs) were formally adopted1: DUS 1958-1: 2018, Surgical sutures – Specification – Part 1: Absorbable; DUS 1958-2: 2018, Surgical sutures – Specification – Part 2: Non Absorbable; DUS 1959: 2018,…
Draft Uganda Standard (DUS) 2140: 2019 explains how to use the ISO 7886 and ISO 7864 standards for hypodermic syringes and hypodermic needles, respectively1. The draft standard outlines sampling and acceptance criteria for ISO 7886 for hypodermic syringes and ISO…
General and specific requirements, packaging rules, labelling criteria, sampling and methods of testing that apply to medical ultrasound gel are set out in a new Draft Uganda Standard (DUS)1. Comments on DUS 2129:2019 are being accepted until 7 June 2019…
A new Draft Uganda Standard (DUS) has been developed for umbilical cord clamps1. DUS 2111: 2018, Umbilical cord clamp – specification, sets out the requirements, test methods and sampling for umbilical cord clamps. It does not, however, include specifications for…
Amendments to The Regulations for Governing the Management of Medical Device have been proposed1 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…
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…
Three guidance documents have been updated by the Health Sciences Authority (HSA) in April 2019. Details are as follows: GN-02: Guidance on Licensing of Manufacturers, Importers and Wholesalers of Medical Devices (Revision 4.2)1 This document provides general guidance on…
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,…
The Philippines (as a signatory to the Association of South East Asian Nations (ASEAN) agreement on the ASEAN Medical Device Directive, AMDD) is mandated to establish an appropriate system for the conduct of clinical investigations of medical devices in line…
A draft Administrative Order has been published1 containing the rules and regulations governing the issuance of an authorisation for an in vitro diagnostic medical device (IVD) based on the Association of Southeast Asian Nations (ASEAN) harmonised technical requirements. The signing…
Public comment is being sought on a draft Administrative Order containing guidelines on the labelling requirements for medical devices, including in vitro diagnostic medical devices (IVDs), that are marketed and/or sold in the Philippines1. These labelling requirements are aligned with…
Guidance has been drafted (MDA/GD/0051) on the requirements for notification of export-only medical devices1, including export-only in vitro diagnostic medical devices, to the Medical Device Authority (MDA). The importation, exportation or placement of a medical device in the Malaysia market…
Requirements for the notification of medical devices for special access are specified in a new guidance document from the Medical Device Authority (MDA/GD/0043)1. The guidance is specifically aimed at applicants who import and/or supply medical devices for the purpose of…
The third edition of a guideline that explains how to register a medical device under Act 737 using an online, web-based system called the Medical Device Centralized Online Application System (MeDC@St) has been published1. This latest revision of the guideline…
Two sets of amendments have been proposed to the Regulations on standard specification of medical devices. The first establishes new standard specifications for 135 Class I medical devices (e.g. endotherapy needle, general purpose, reusable)1. The second creates new standard specifications for…
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 Ministry of Health, Labour and Welfare has confirmed that Japan will continue to participate in the Medical Device Single Audit Program (MDSAP) until at least 31 March 20201. MDSAP allows medical device manufacturers to meet the quality requirements in…
Registration, inspection and other related fees for regulatory activities conducted by the Pharmaceutical and Medical Devices Agency (PMDA) were increased with effect from 1 April 2019. The full fee structure (in Japanese) has been posted on the PMDA website1. …
The Department for Pharmaceuticals, in association with the Bureau of Indian Standards (BIS), has published six draft Quality Control Orders and invited comments on them from stakeholders1: Medical Devices – Medical Electrical Equipment (Quality Control) Order, 2018; Medical Devices…
According to a Ministry of Health and Family Welfare Notification dated 8 February 2019, eight new device types intended for use in human beings are being classified as drugs with effect from 1 April 20201. This decision, which is in accordance with…
New Guidance Notes (GN-10) for the listing of Local Responsible Persons (LRPs) have been drafted by the Medical Device Control Office (MDCO)1. In order to be listed, an LRP must be a legal person with business registration in Hong Kong.…
Amendments have been drafted1 to the Regulations for the Supervision and Administration of Medical Devices to update the rules that apply to entities involved in the research and development, production, operation and use of medical devices, as well as the…
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…
In March 2019, the Therapeutic Goods Administration issued guidance in the form of a question and answer document1 on the use of market authorisation evidence from comparable overseas regulatory bodies for medical devices. Questions that are answered in the document…
Interested parties had until 29 April 2019 to comment on a proposal1 to introduce a new classification rule for invasive medical devices that administer medicines or biologicals by inhalation. At present, Australia classifies these devices as low risk (Class I)…
A period of public consultation has been held on a proposal1 to simplify the medical device classification rules by amending the classification of active implantable medical devices (AIMDs) from Class AIMD to Class III. The current conformity assessment procedures applied to…
A new classification rule has been proposed1 for inclusion in Part 2 (Rules for non-invasive medical devices) of Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002 to align with the second paragraph of classification Rule 3 in Regulation…
It has been proposed that a new classification rule1 should be included in the Therapeutic Goods (Medical Devices) Regulations 2002 to align with Rule 21, Annex VIII, Chapter III of Regulation (EU) 2017/745 on medical devices2. As a result, all…
The Therapeutic Goods Administration (TGA) has proposed1 aligning Australia’s classification rules for transient or short-term surgically invasive medical devices used in direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS) with those in the…
Interested parties had until 31 March 2019 to comment on how software, including Software as a Medical Device (SaMD), is regulated in Australia1. The consultation focused on proposed regulatory reforms for medical device software, including software that functions as a…
A period of public consultation has been held on how personalised medical devices are regulated in Australia1. This consultation followed on from a previous consultation undertaken in 2017, which confirmed that the public supports reforms of the current regulatory requirements…
Taking into account the amendments being implemented by the European Regulation on Medical Devices (2017/745), the Therapeutic Goods Administration is considering the introduction of a new classification rule for spinal implantable medical devices that is appropriately tailored for the Australian…
A new mandatory Mexican Official Standard on excimer laser ophthalmic surgery practices has been drafted1. PROY-NOM-029-SSA3-2018, Regulation of health services – Practice of excimer laser ophthalmic surgery, applies to all medical healthcare facilities in the public, social and private sectors…
The Health Regulatory Agency of Honduras (Agencia de Regulación Sanitaria, ARSA) has drafted comprehensive regulations for the control of medical devices and other devices of sanitary interest, as well as controls for related establishments1. The draft regulations establish provisions on…
A second revision of Technical Regulation (PRTE INEN) No 049, Natural rubber latex male condoms, has been drafted and circulated for comment by the Ecuadorian Standardization Institute1. This revised standard establishes the requirements that must be met by natural rubber…
