The Medicines and Healthcare products Regulatory Agency (MHRA) has published An introductory guide to the medical device regulation (MDR) and the in vitro diagnostic medical device regulation (IVDR)1. The Introductory Guide takes the form of an interactive pdf and has…
The French National Agency for the Safety of Medicines and Health Products (ANSM) has established its first Temporary Specialised Scientific Committee (CSST) to address issues concerning the cybersecurity of medical device software1. The CSST is composed of external experts, chosen…
On 10 August 2017, Commission Implementing Decision (EU) 2017/1445 was published1 to confirm that the group of products whose principal intended action, depending on proanthocyanidins (PAC) present in cranberry extract (VacciniumMacrocarpon), is to prevent or treat cystitis, does not fall…
The European Commission has published a draft Implementing Regulation1 on the list of codes and corresponding types of devices for the purposes of specifying the scope of the designation as Notified Bodies in the field of medical devices under Regulation…
Interested parties have until 18 April 2018 to submit comments on a draft guidance from the International Medical Device Regulators Forum’s (IMDRF’s) Good Regulatory Review Practices Working Group entitled: N47, Essential Principles of Safety and Performance of Medical Devices and…
Vietnam’s Ministry of Health (MoH) has recently issued an important notification and implementing guidelines relating to Decree No 36/2017/ND-CP (Decree 36)1 on medical device management. The key notification was issued under Official Dispatch No 7165/BYT-TB-CT, dated 14 December 2017 (Dispatch 7165)2.…
The Saudi Food and Drug Authority has drafted a document for comment purposes that is entitled, Project on Guidance on Requirements for Following Up and Closing Medical Devices Field Safety Notices (FSNs)1. The draft guidance, which applies to local manufacturers…
In order to streamline the process for obtaining customs clearance of radiation devices and to ensure the traceability of those devices from importation through to the end user, new guidelines have been published in FDA Circular No 2017-0131. The Circular…
Efficiency changes have been made to the application process for a variation to a Certificate of Product Registration (CPR) in an effort to deal with the increasing volume of variation applications being submitted to the Center for Device Regulation, Radiation…
On 16 January 2018, the Drug Regulatory Authority of Pakistan, with the approval of the Federal Government, published the Medical Devices Rules, 2017 with immediate effect1. Topics covered by the new Rules include the following: definitions; establishment licensing; classification and…
At a meeting on 18 December 2017, the Medical Device Authority of Malaysia agreed to an extension of the moratorium on the registration of medical devices following pressure from the medical device industry1. The one-off extension of the moratorium is…
In a press release dated 11 December 2017, the Korean Ministry of Food and Drug Safety announced1 that it had become the 10th member of the International Medical Device Regulators Forum (IMDRF), a move that it hopes will boost the…
The South Korean Ministry of Health and Welfare, other governmental organisations, and prominent industry leaders have agreed on measures to support the development and marketing of technological advancements and innovative medical devices1. At a meeting on 26 December 2017, the…
Towards the end of 2017, the Ministry of Food and Drug Safety (MFDS) in the Republic of Korea issued a number of proposed regulatory amendments for public comment; details are as follows: Proposed amendments to the Regulations on Approval, Notification…
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,…
Clarification has been provided1 to importers and India’s port offices following reports of imported consignments of medical devices and in vitro diagnostics (IVDs) being unnecessarily detained at their point of entry into the country. In cases of slight discrepancy between…
A list has been published of medical devices and in vitro diagnostics (IVDs) that will be regulated under the Medical Devices Rules, 2017 along with their risk class, as per the provisions of Rule 41. The list explains the general…
The Eurasian Economic Commission has proposed1 a number of amendments to Section 18 of Chapter II of the Uniform Sanitary, Epidemiological and Hygienic Requirements for Products Subject to Sanitary and Epidemiological Supervision (Control). The proposed changes are as follows2: The…
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;…
On 29 December 2017, the China Food and Drug Administration released the first version of its Guiding Principles on the Registration of Mobile Medical Devices1. These guidelines apply to equipment and/or software that implements one or more medical uses using…
A number of significant changes have been proposed1 to the Regulations on the Supervision and Administration of Medical Devices in an effort, inter alia, to align these Regulations with the improvements recommended in the In-Depth Reform of the Review and…
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,…
China’s new Medical Device Network Sales Supervision and Management Measures (Order No 38) will come into force on 1 March 20181. This approach to the supervision and management of the medical equipment sales network in China applies to companies involved…
The Therapeutic Goods Administration (TGA) held a consultation on the future options for the regulation of personalised and 3D printed medical devices; the comment period ended on 22 December 20171. Any regulatory reforms would affect industry, healthcare professionals and patients of…
A new guidance document was published in January 20181 to outline the process for obtaining designation for priority review of either Therapeutic Goods Administration (TGA) conformity assessment, or inclusion in the Australian Register of Therapeutic Goods (ARTG). Applications that are…
On 15 January 2018, version 2.0 of the Uniform Recall Procedure for Therapeutic Goods (URPTG) came into effect1, replacing the 2004 version. The new version of the URPTG must now be followed by sponsors. The URPTG provides a consistent approach…
The Therapeutic Goods (Manufacturing Principles) Determination 20181 came into effect on 1 January 2018 and specifies the manufacturing principles that apply to specific therapeutic goods as set out in three Divisions: Division 1 – therapeutic goods including Active Pharmaceutical Ingredients and…
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…
Consultation has been held on a Draft Resolution for the mandatory inclusion of Unique Device Identification (UDI)/International Medical Device Regulators Forum (IMDRF) standard barcodes on traceability tags for cardiac stents, and hip and knee implants1. It is hoped that the…
Resolution RDC No 203 of 26 December 2017 sets out the criteria and procedures for the importation, on an exceptional basis, of products that are subject to sanitary surveillance but are not registered with the National Health Surveillance Agency (ANVISA)1.…
The procedures for importing products subject to sanitary surveillance, which includes medical devices, into Brazil have been simplified by Resolution RDC No 208/20181. Probably the most significant change is that imported devices will no longer have to undergo inspections at…
Resolution RDC No 183 concerning the Good Manufacturing Practice (GMP) certification of foreign medical device manufacturers was published in the Brazilian Official Journal on 19 October 20171. This Resolution sets out the inspection programmes and administrative procedures that apply with…
On 22 January 2018, the validity period of health product registrations and registration renewals in Brazil was extended from five years to 10 years following publication of Resolution RDC No 2111. Products already registered with the National Health Surveillance Agency…
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…
Interested parties have until 26 February 2018 to comment on a proposed programme for manufacturer reporting of certain device malfunction Medical Device Reports (MDRs) in summary format (i.e. the Voluntary Malfunction Summary Reporting Program)1. This proposed, voluntary programme reflects the…
The Center for Devices and Radiological Health (CDRH) is running a Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program (CfQ Pilot Program) from 2 January 2018 until 28 December 20181. This voluntary pilot programme has been designed to:…
On 6 April 2018, the Food and Drug Administration’s (FDA’s) adverse event coding system will be amended, and corresponding updates will be made to the Center for Devices and Radiological Health’s electronic Medical Device Reporting (eMDR) system1. Initially, changes will…
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…
Two draft guidance documents1-4 have been published to help manufacturers of in vitro diagnostic (IVD) devices apply for and receive Clinical Laboratory Improvement Amendments (CLIA) waivers. The comment period for each draft guidance document was originally due to end on…
Public Warning and Notification of Recalls Under 21 CFR [Code of Federal Regulations] Part 7, Subpart C; Draft Guidance for Industry and FDA [Food and Drug Administration] Staff has been published for a period of public consultation1. When finalised, the…
Comments are being accepted until 15 February 2018 on a draft guidance document concerning the evaluation of devices used with Regenerative Medicine Advanced Therapies (RMATs)1,2. When finalised, it is hoped that this guidance will provide device manufacturers, applicants and sponsors…
Comments have been sought on a draft guidance1,2 that describes the policies that the Food and Drug Administration (FDA) intends to use to implement the Breakthrough Devices Program (BDP). The BDP is a voluntary programme for certain medical devices that…
Comments are being solicited on a draft guidance document entitled, Investigational IVDs [in vitro diagnostics] Used in Clinical Investigations of Therapeutic Products11,2, which describes: when the Investigational Device Exemption (IDE) Regulation may apply to certain clinical investigations of therapeutic products;…
Interested parties have until 19 March 2018 to submit comments on a proposed guidance document1,2 entitled, Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices, which updates and clarifies the policy outlined in the 2003 version of the…
A period of consultation has been held on a draft guidance document entitled Acceptance Review for De Novo Classification Requests1,2. When finalised, this guidance will explain the procedures and criteria the Food and Drug Administration (FDA) intends to use when…
Comments are being solicited until 15 March 20181 on new draft guidance entitled The Least Burdensome Provisions: Concept and Principles2,3. The draft guidance defines ‘least burdensome’ as the minimum amount of information necessary to address a regulatory question or issue…
