On 23 March 2026, the Food and Drug Administration (FDA) revoked1 the regulations entitled Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European…
When the Food and Drug Administration began implementing the Quality Management System Regulation on 2 February 2026, it discontinued use of its Quality System Inspection Technique for medical device inspections. It now conducts inspections using the process described in the…
Comments have been sought on a draft Circular entitled Guidelines on the Inspection of Medical Device Establishments1. This draft Circular aims to provide guidance on the inspection of medical device establishments and the specific requirements that the Food and Drug…
At the 29th meeting of the Global Harmonization Working Party (GHWP) in Bangkok, Thailand on 4 December 2025, the following Working Group (WG) guidance documents were endorsed1 according to the simple majority rule: WG1-WG2-WG3, Guidance on Determining of Lead Authority…
The Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Amendment Determination 2025, which specifies the updated information that must accompany an application to include a medical device in the Australian Register of Therapeutic Goods (ARTG), came into effect…
The Medical Device Authority (MDA) has been officially recognised as an Affiliate Member of the Medical Device Single Audit Program (MDSAP) by the MDSAP Regulatory Authority Council with effect from 16 September 20251. With this recognition, the MDA will begin…
Selection criteria New guidance has been published1 to provide information on how the Therapeutic Goods Administration (TGA) selects medical device applications for audit, and is intended to help sponsors prepare and respond to a request for information if a device…
In May 2025, the Food and Drug Administration (FDA) announced1 its intention to expand the use of unannounced inspections at foreign manufacturing facilities that produce medical devices, foods, essential medicines, and other medical products intended for US consumers and patients.…
Final guidance has been published1,2 to describe the Food and Drug Administration’s (FDA’s) current thinking on its use of remote regulatory assessments (RRAs) and to provide answers to frequently asked questions on RRAs. The final guidance makes further revisions to,…
The South African Health Products Regulatory Authority (SAHPRA) has joined the Medical Device Single Audit Program (MDSAP) as an affiliate member1. It is hoped that MDSAP membership will result in improved regulation of medical devices and in vitro diagnostics in…
Rules to control the border inspections and examination of imported condoms (including those with spermicidal lubricant), general medical masks, surgical masks, N95 medical masks, and COVID-19 self-test kits have been amended1. Amendments to Attachment 1 of Article 3, Attachment 2…
Introduction The Medical Device Single Audit Program (MDSAP) is an initiative that allows medical device manufacturers to undergo a single regulatory audit to satisfy the requirements of multiple participating regulatory authorities. Fully operational since 2017, MDSAP has revolutionised the regulatory…
A fifth revision of Medical Device Coordination Group MDCG 2019-6, Questions and Answers: Requirements Relating to Notified Bodies, was released in February 20251. MDCG 2019-6 presents questions and answers on requirements relating to Notified Bodies under Regulation (EU) 2017/745 on…
In order to standardise and improve the quality of inspections of medical device clinical trials, the National Medical Products Administration has revised its Key Points and Judgment Principles for Inspection of Medical Device Clinical Trial Projects1. The drug regulatory authorities…
Final guidance entitled, 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review1,2, which supersedes the previous 510(k) Third Party Review Program guidance, clarifies how the Food and Drug Administration (FDA) will use third party review organisations…
Feedback is being sought until 17 February 2025 on two new guidance documents developed as part of the proposed new risk-based application audit framework: Selection criteria for non-mandatory application audits1 This guidance document outlines and clarifies the selection criteria…
Commission Implementing Regulation (EU) 2024/2699 of 18 October 20241 sets out detailed procedural rules for the cooperation of the Member State Coordination Group on Health Technology Assessment and the European Commission with the European Medicines Agency in the form of…
In an effort to standardise and guide the on-site inspection of medical device business quality management standards, the National Medical Products Administration has developed and issued the Guiding Principles for On-site Inspection of Medical Device Business Quality Management Standards1. These…
Final guidance entitled, Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection1,2 has been published to supersede the October 2014 final guidance entitled, Circumstances That Constitute Delaying, Limiting, or Refusing a Drug Inspection, thereby extending the…
MDCG 2022-13 Rev. 1, Designation, Re-assessment and Notification of Conformity Assessment Bodies and Notified Bodies, was published in June 20241. Revision 1 of the Medical Device Coordination Group (MDCG) document adds guidance on the conduct of joint assessments relating to…
In May 2024, the Medical Device Coordination Group (MDCG) issued the following templates for preliminary assessments/re-assessments of Notified Body documentation by Designating Authorities: MDCG 2024-6, Preliminary re-assessment review template – MDR (Regulation (EU) 2017/745)1; MDCG 2024-7, Preliminary assessment review…
Comments have been sought on a revised draft guidance for industry entitled Conducting Remote Regulatory Assessments – Questions and Answers1,2. This draft revises the draft guidance of the same name from July 20223. The original draft guidance clarified the Food…
The validity of Certificates of Good Manufacturing Practice (Boas Práticas de Fabricação, BPF) for medical device manufacturers granted through the Medical Device Single Audit Program (MDSAP) has been extended from two to four years through the publication of Resolution RDC…
Regulatory authority The Iranian Food and Drug Administration (IFDA) is an independent agency which operates under the Ministry of Health and Medical Education and oversees the evaluation, classification, registration, licensing, and importation of all medical devices. The head of the…
In November 2023, the Global Harmonization Working Party (GHWP) finalised and released the following guidance documents: GHWP/WG1-WG2-WG3/F002:2023, Principles of Regulatory Requirements for Electronic Instructions for Use (eIFU)1 GHWP/WG2/F001:2023, Guidance for Additional Considerations to Support Conformity Assessment of In vitro…
Draft Resolution 1208 of 16 October 20231 proposes changes to the administrative procedures for the granting of Good Manufacturing Practice (Boas Práticas de Fabricação, BPF) certification and certification of Good Distribution and Storage Practices, to allow for an increase in…
Interested parties have until 20 November 2023 to submit comments to the Global Harmonization Working Party (GHWP) Secretariat (secretariat@ghwp.info) on the following proposed guidance documents: Guidance Document on the Risk-Based Approach to Quality Management System Aspects: ISO 13485:20161 Guidance for…
The comment period has now closed on a consultation concerning how the Therapeutic Goods Administration (TGA) selects medical device applications for audit and how the TGA conducts these audits1. This consultation sought feedback on key elements of a proposed application…
Introduction The regulatory gap between the actions of medical device companies and the expectations of the US Food and Drug Administration (FDA) is seen through violations captured in issued warning letters. Many violations of Title 21 of the Code of…
EU: Changes made to frequency of complete re-assessments of Notified Bodies The frequency of complete re-assessments of Notified Bodies has been changed under both Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical…
An eighth revision of the Medical Device Single Audit Program (MDSAP) Audit Approach document, dated 1 April 2023, has been published1. This document contains specific instructions for performing audits under the MDSAP programme. It incorporates an audit sequence, instructions for auditing each…
The following definition of ‘hybrid audits’ has been agreed by the Medical Device Coordination Group (MDCG) and published in MDCG 2022-171: ‘A ‘hybrid audit’ should be understood as an audit on the premises of the manufacturer or its supplier(s)…
MDCG 2023-2 provides templates1 for Notified Bodies to use to list their standard fees for conformity assessment activities under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). Article 50 of…
The first revision of MDCG 2022-4, Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR [Medical Device Regulation] with regard to devices covered by certificates according to the MDD [Medical Device Directive] or the AIMDD…
In a fourth revision of the question-and-answer guidance from the Medical Device Coordination Group (MDCG) on the requirements relating to Notified Bodies1, question III.6. (What is the meaning of the term “employed” in MDR [Medical Device Regulation] Article 36(1) /…
A period of public consultation has been held on a draft guidance entitled, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection1,2. This draft guidance updates the 2014 guidance entitled Circumstances that Constitute Delaying, Denying, Limiting,…
The extraordinary measures detailed in transmittal AO-2020-10, which concern alternative arrangements for Medical Device Single Audit Program (MDSAP) audits because of COVID-19 quarantine orders and travel restrictions, have been extended for a further three months until 30 September 20221. However, this…
MDCG 2022-4, Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR [Medical Device Regulation] with regard to devices covered by certificates according to the MDD [Medical Device Directive] or the AIMDD [Active Implantable Medical Device Directive],…
The Medicines and Healthcare products Regulatory Agency (MHRA) has clarified its range of investigatory and enforcement powers with respect to medical devices in the form of updated guidance1. A manufacturer based in the UK who intends to supply medical devices…
From 1 April 2022, Japan will formally start accepting Medical Device Single Audit Program (MDSAP) reports as part of its Quality Management System (QMS) process for product registration in Japan1. In general, QMS audits in Japan are either document based…
With effect from 1 March 2021, the following medical equipment must undergo inspection/testing of their safety and technical features1: ventilators; anaesthesia machines with breathing systems; electric scalpels; incubators for newborn babies; defibrillators; artificial kidney machines. The Ministry of…
In light of the COVID-19 pandemic’s impact on foreign travel, the Taiwan Food and Drug Administration (TFDA) has announced a temporary suspension of overseas inspections of medical device facilities1. Routine follow-up inspections that were due in 2020 will be converted…
In light of the COVID-19 pandemic and the difficulty of carrying out overseas inspections, Argentina will accept1 ISO 13485 or Medical Device Single Audit Program (MDSAP) certificates instead of certificates issued by the National Administration of Drugs, Food, and Medical…
Answers to frequently asked questions have been published as Medical Device Coordination Group guidance MDCG 2020-171 to support the implementation of guidance document MDCG 2020-4, Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine…
In response to the ‘exceptional and unforeseen circumstances’ caused by COVID-19, the European Commission has published a Notice1 on the application of Sections 2.3 and 3.3 of Annex IX to Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU)…
New guidance has been issued1 for Notified Bodies on the use of Medical Device Single Audit Program (MDSAP) audit reports in the context of surveillance audits carried out under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746…
A new compliance programme (7356.000) was launched in June 2020 for inspections of Center for Drug Evaluation and Research (CDER)- and Center for Devices and Radiological Health (CDRH)-led combination products1. This compliance programme focuses on inspections of combination product manufacturers…
Guidance has been issued to clarify the updated processes and standards for domestic and foreign device establishment inspections (other than for-cause inspections)1,2. The guidance describes how the Food and Drug Administration will implement uniform inspection processes and standards. It also…
The Food and Drug Administration (FDA) has developed a new rating system in an effort to determine the safest and most appropriate time to resume prioritised domestic inspections of FDA-regulated facilities and other associated activities1. The COVID-19 Advisory Rating system…
New guidance for industry and Food and Drug Administration (FDA) staff has been released concerning non-binding feedback after certain FDA inspections of device establishments1. This guidance explains how the owner, operator or agent in charge of a device establishment may…
