The second revision of the Ecuadorian Technical Regulation (RTE INEN) No 181, Respiratory protection equipment, has been issued pursuant to Resolution No 17 335 of 14 June 2017 of the Under-Secretariat for the Quality System of the Ministry of Industry and Productivity,…
Clarification has been provided1 on how the Food and Drug Administration (FDA) will now process requests for recognition of voluntary consensus standards following changes implemented by the 21st Century Cures Act. These changes include adding a 60-day timeframe for the…
The US Food and Drug Administration (FDA) has announced the addition, withdrawal, correction and revision of certain consensus standards that the Agency will recognise for use in pre-market reviews and other requirements for devices. On 21 August 2017, the FDA…
Guidance has been drafted1,2 to assist industry in understanding when a microneedling product is a medical device as defined in section 201(h) the Federal Food, Drug and Cosmetic Act. ‘Microneedling products’ is a generic term that encompasses instruments with common…
On 10 August 2017, a final version of the guidance document entitled Qualification of Medical Device Development Tools (MDDT) was released1,2. This guidance formalises the MDDT programme and provides guidance to Food and Drug Administration staff, industry, healthcare providers, researchers,…
A draft version of Kenya Standard DKS 2613:2017, Orthoses – Neck and Spinal – Specification, was circulated for comment in November 2017 and scheduled for adoption in December 20171. This standard was prepared by TC 132, Assistive Devices and Products…
Two parts of Kenya Standard DKS 2612 on prostheses have been drafted for proposed adoption on 1 March 2018. DKS 2612-1: 2017, Prostheses – Specification, Part 1: Upper Limb Prostheses1, specifies the requirements that apply to upper limb prostheses, including medical…
A partial amendment1 of the Standard for Biological Ingredients (MHLW Notification No 210/2003) has been proposed in order to provide updated recommendations on the necessary measures to be taken when a biological ingredient is used in the manufacture of a…
A revision to part 6 of the Israeli Mandatory Standard SI 1268, which concerns the colour coding for identification of single-use hypodermic needles, will enter into force on 20 February 20181. The revision adopts the international standard ISO 6009: 2016,…
On 11 December 2017, six new medical device industry standards were published1 by the China Food and Drug Administration (CFDA) and will come into operation on 1 December 2018: YY/T 0588-2017, Flow cytometry; YY/T 1585-2017, Total 25-hydroxy vitamin D assay…
In late 2017 and early 2018, the China Food and Drug Administration (CFDA) has issued a raft of new technical guidelines pertaining to medical devices, including the following: Guidelines for the Technical Review of the Registration of Aminotransferase Assay Reagents1;…
In the final quarter of 2017, China made three important announcements affecting the medical device industry. These relate, inter alia, to the China Food and Drug Administration’s (CFDA’s) plans to abolish mandatory in-China type testing, accept international clinical trial data,…
Normative Instruction (IN) No 22 of 20 October 20171 approved updates to Annexes I and II to IN No 4 of 24 September 2015. Annex I to IN No 4/2015 contains a list of technical standards to be adopted in the certification…
On 4 December 2017, the US Food and Drug Administration (FDA) published an update to its list of recognised consensus standards entitled Modifications to the List of Recognized Standards, Recognition List Number: 0481. The update adds one radiology standard and…
A new leapfrog guidance document has been issued to provide the Food and Drug Administration’s initial thoughts on the technical considerations specific to devices using additive manufacturing, the broad category of manufacturing encompassing 3-dimensional (3D) printing1,2. The purpose of this…
The Radiation Emitting Devices Regulations have been amended to update the regulatory requirements for dental X-ray equipment1 in order to enable Health Canada to exercise appropriate regulatory oversight of their sale, re-sale, lease and importation in Canada, and ultimately to…
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…
New editions of ISO 14971, Medical devices – Application of risk management to medical devices1 and its companion document ISO/TR 24971, Medical devices – Guidance on the application of ISO 149712 are being prepared by a Joint Working Group from…
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 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 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…
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 are being accepted until 11 July 2018 on draft guidance entitled, Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence Through Performance Criteria; Draft Guidance for Industry and Food and Drug Administration Staff1,2. This draft guidance document proposes an…
The Food and Drug Administration (FDA) has finalised two guidance documents that provide recommendations for designing, developing and validating tests that use next generation sequencing (NGS) to scan a person’s deoxyribonucleic acid (DNA) to diagnose genetic diseases, which are usually…
