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…
The Egyptian Drug Authority has announced a simplification to the technical file requirements for locally manufactured medical supplies1. Local manufacturers holding a European CE Certificate are permitted to submit registration (or re-registration) files without needing to submit the following documents:…
On 2 February 2024, the Food and Drug Administration (FDA) issued the final rule entitled, Medical Devices; Quality System Regulation Amendments (the Quality Management System Regulation (QMSR) Final Rule). This rule amended the device current Good Manufacturing Practice (cGMP) requirements…
The Food and Drug Administration (FDA) has issued a draft guidance1,2 to provide advice to industry and FDA staff on the expectations for Quality Management System Regulation (QMSR) requirements for pre-market submissions once the final rule amending Title 21 of…
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…
A Decision dated 18 December 2025 has established the procedures for the internal and external quality control of computed tomography (CT) scanners. This decision will enter into force 18 months after its publication; operators of CT scanners must implement these…
Introduction This article provides a comprehensive overview of recent regulatory developments in South Africa pertaining to medical devices and in vitro diagnostics (IVDs), as announced by the South African Health Products Regulatory Authority (SAHPRA). One key update involves the phased…
With effect from 1 June 2025, a holder of a licence to manufacture and distribute (import) medical devices and in vitro diagnostics (IVDs) who submits an application for an amendment to a licence, and who is already in possession of…
The National Medical Products Administration has issued the Quality Management Standards for Online Sales of Medical Devices, which will come into effect on 1 October 20251,2. These Standards are an important measure to implement the provisions of laws and regulations…
Introduction The National Drug Authority (NDA) has a mandate to ensure the availability, at all times, of essential, efficacious and cost-effective drugs to the entire population of Uganda, as a means of providing satisfactory healthcare and safeguarding the appropriate use…
Consultation was held in March 2025 on a proposed partial revision1 of the Medical Device Manufacturing and Quality Control Standards. The revision proposes to delegate Good Manufacturing Practice (GMP) assessments to specialist review organisations for Class 3 medical devices to…
Circular No. (5) for the Year 20251, dated 24 March 2025, specifies certain amendments to Resolution No. (69) of 2024, which amends certain provisions of Resolution No. (48) of 2020 concerning the quality control of medical devices and products. The…
Regulatory authority The Ministry of Food and Drug Safety (MFDS) is responsible for medical device regulation in the Republic of Korea. It oversees the evaluation, classification, registration, and licensing of all medical devices. It is also responsible for reviewing and…
The Egyptian Drug Authority (EDA) has set out1 the procedures to be followed in case of expiry of quality certificates for medical supplies and devices issued under the former European Directive 93/42/EEC on medical devices. In accordance with the implementation…
Introduction On 2 February 2024, the Food and Drug Administration (FDA) published a final rule to implement the most significant revisions in the FDA’s quality system requirements for medical devices in decades1. Specifically, the final rule – known as the…
On 31 January 2024, a final rule was published1 to amend the device current Good Manufacturing Practice requirements of the Quality System (QS) Regulation under Title 21 of the Code of Federal Regulations Part 820, to align more closely with…
In this second ‘Peer to Peer Learning’ article, Xi Yun shares her experiences of improving the risk management process of a Quality Management System (QMS) for a contract manufacturer whose primary business is in tooling, moulding, and assembly for medical…
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…
The following five guidance documents have been updated recently by the Therapeutic Goods Administration (TGA): TGA quality management system audits and certification – Guidance for manufacturers of medical devices (version 2.0, December 2023)1 This guidance provides information for medical…
Announcement No. 153 of December 20231 from the National Medical Products Administration concerned the publication of quality management standards for medical device operations (Good Manufacturing Practices, GMP). These standards will take effect on 1 July 2024 and, at that time,…
In response to a Decision from the General Registration Technical Committee Meeting, the Medical Device Authority (MDA) has determined1 that, from 1 January 2024, only the recognised Quality Management System (QMS) standards stated in Table MY1 will be accepted for…
On 5 January 2024, the Ministry of Public Health published an Announcement regarding the need to establish a quality system for importing or selling medical devices in Thailand1. This Announcement will become effective on 5 January 2025. According to this…
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…
To ensure the quality, safety and efficiency of medical device production, guidelines for implementing a quality system for medical device manufacturing have been drafted1. If finalised, the announcement of the guidelines will come into force 120 days after publication in…
In an effort to ensure the quality, safety and performance of medical devices throughout the supply chain, the Ministry of Public Health has drafted good practice criteria and procedures that will apply to Quality Management Systems for importing or selling…
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…
Guiding Principles for On-site Inspection of the Quality Management of Enterprises Specially Providing Medical Device Transportation and Storage Services have been issued1 to support the implementation of the Appendix to the Quality Management Standards for Medical Device Operation2. The Guiding…
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…
Regulatory essentials Regulatory authority Directorate of Medicines and Pharmacy (Direction du Médicament et de la Pharmacie, DMP) Classification system Medical devices: Classes I, Im (measuring), Is (sterile), IIa, IIb, III In vitro diagnostic reagents: None Registration requirements Application form, administrative…
The Egyptian Medicines Authority has announced that the deadline for complying with the requirements for medical supplies that do not have international quality certificates is 17 July 20231. Therefore, local manufacturers are advised to ensure they submit the necessary registration…
An Appendix to the Quality Management Standards for Medical Device Operation concerning the quality management of enterprises specialising in providing medical device transportation and storage services (i.e. third-party logistics companies) came into force on 1 January 20231,2. The Appendix sets…
The Regulations on the Supervision and Administration of Enterprises Implementing the Main Responsibility for Medical Device Quality and Safety have been published in Announcement No. 124 of 2022 and will come into force on 1 March 20231,2. These Regulations encourage…
The European Association of Medical Devices Notified Bodies (Team-NB) has recently released several Position Papers to help standardise the approaches taken by Notified Bodies in an effort to improve efficiency and provide more certainty to both Notified Bodies and industry:…
The Central Administration of Medical Devices has published a regulatory guide1 for the registration of locally manufactured medical devices that do not have international quality certificates. An application must be submitted online and will be evaluated by a scientific committee,…
Introduction The regulatory framework for medical devices, including in vitro diagnostic medical devices (IVDs), is the set of provisions that make up the technical, legal and regulatory basis that guarantees the safety, efficacy, performance and effectiveness of these products. This…
Introducción El programa regulador para equipos y dispositivos médicos, incluyendo los dispositivos médicos de diagnóstico in vitro (DMDIV), es el conjunto de disposiciones que forman la base técnica, legal y normativa que garantiza la seguridad, eficacia, desempeño y efectividad de…
The National Health Regulatory Authority has informed1 all importers and suppliers of medical devices that the verification of medical device quality certificates via email will return to the normal validation period of three months instead of the temporary six-month extension…
Public comments have been solicited on a revised draft of the Medical Device Registration Quality Management System Verification Guide1. This guide applies to the on-site verification of the registered Quality Management System by the medical device regulatory authorities for Class…
New guidelines have been produced1 on the management of inspections of medical device manufacturers’ Good Manufacturing Practices (GMP), which are synonymous with Quality Management System (QMS) inspections. Article 20, sub-article 4 of the Food and Medicine Administration Proclamation 1112/2019 requires…
The South African Health Products Regulatory Authority (SAHPRA) has issued a communication exempting medical device establishment holders from providing an ISO 13485 certificate upon application for an establishment licence renewal for a period of three years or until a further…
Comments are being accepted until 24 May 2022 on a proposal1 to amend the device current Good Manufacturing Practice (cGMP) requirements of the Quality System (QS) regulation (Title 21 of the Code of Federal Regulations Part 820) primarily to incorporate…
On 1 May 2017, the China Food and Drug Administration’s standard YY/T0287-2017/ISO13485:2016, Medical devices – Quality management systems – Requirements for regulatory purposes, came into effect1. The Chinese standard is equivalent to the internationally-harmonised standard ISO 13485:2016. It specifies that the…
Minor updates have been made to GD207, Guidance on the Content of ISO 13485 Quality Management System Certificates Issued by Health Canada Recognized Registrars1. The new version, dated 14 March 2017, now includes references to ISO 13485:2016 (CAN/CSA-ISO 13485:16), as…
The idea of a common Eurasian medical device market The Eurasian Economic Union (EAEU) comprises Russia, Kazakhstan, Belarus, Armenia and Kyrgyzstan and has a combined population of more than 184 million. In its first five years, the gross domestic product…
Introduction The VietNamese healthcare market is in a time of change as the government seeks to invest in aging facilities and equipment while enticing foreign manufacturers with new, friendlier regulations. Seen as a high potential market, only specific medical devices…
An amendment has been drafted to the Medical Devices Rules, 2017 that, if finalised, would temporarily ease the registration requirements concerning ISO 13485 certification. Under the draft proposal, applicants have until 28 February 20221 (a previous draft had stated 30…
Introduction The medical device industry has been largely unregulated in South Africa with the first medical device regulations introduced in 20161. As such, South Africa is still within the early stages of developing and implementing medical device regulations. The South…
On 1 January 2022, the European Medicines Agency’s (EMA’s) Guideline on quality documentation for medicinal products when used with a medical device will become effective1. This guideline outlines the information that should be presented in the quality part of a…
On 8 September 2021, the European Committee for Standardization (CEN) made available EN ISO 13485:2016/A11:20211. This revised standard for medical device Quality Management Systems has been amended to include new Annexes ZA and ZB that link the requirements of Regulation (EU) 2017/745…
