An updated English compilation of the Medical Device GMP [Good Manufacturing Practice] Regulations was issued in February 20261. The compilation covers four main pieces of legislation: Enforcement Rule of the Medical Devices Act (effective 31 October 2025) [Ordinance of…
Certificates of Free Sale, Manufacturing Certificates and Export Certificates will be issued electronically from 1 March 20261. Upon completion of the application and successful payment, the electronic certificate will be issued by the Medical Device Authority via email within seven…
Revisions of several guidance documents were published in October 2025: GN-34: Guidance Document for IVD Analysers1 The second revision of GN-34 provides updated guidance to product owners and registrants concerning in vitro diagnostic (IVD) analysers and their associated accessories.…
Interpretive guidance1 has been published by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) for Mexican Official Standard NOM-241-SSA1-2025, Good Manufacturing Practices for Medical Devices. This guidance clarifies how manufacturers should meet Quality Management System (QMS) and Good…
On 31 December 2025, the following five guidance documents were updated with immediate effect: GN-07, Guidance on Listing Matters for Medical Device Importers1 Section 8.2.2 has been added to read: ‘8.2.2 If the existing importer list has expired, the…
On 4 November 2025, the National Medical Products Administration released a new version of the Good Manufacturing Practice for Medical Devices, which will come into effect on 1 November 20261. This revised version significantly updates the 2014 version to strengthen comprehensively the…
The National Health Surveillance Agency (Anvisa) has unified the subject codes used in applications for the Certificate of Good Manufacturing Practices (Certificado de Boas Práticas de Fabricação, CBPF) for medical devices to simplify the regulatory process, reduce bureaucracy, and align…
Comments are being sought on a 35-page exposure draft entitled Good Manufacturing Practice for Medical Devices1. No date of adoption or date on entry into force have been set yet. However, when finalised, this document will repeal Good Manufacturing Practice…
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…
Following a review by the National Audit Office, the Swedish government has given a mandate to the Health and Care Inspectorate (Inspektionen för vård och omsorg, IVO) and the Medical Products Agency (Läkemedelsverket, LV) to investigate the possibility of transferring…
The final version of Official Mexican Standard NOM-241-SSA1-2025, Good manufacturing practices for medical devices, was published in April 20251. Among the modifications contained in this latest version of the standard is the elimination of the chapter relating to the classification…
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…
The Central Administration for Medical Supplies has announced1 the activation of a link that allows local medical supply manufacturers to upload the required documents (specified in the link) for review by the relevant department. This link is for use by…
Announcement No. 30 of 2025 has been published to amend and optimise matters relating to the manufacture of imported medical devices1. The foreign-invested companies referred to in the Announcement may be companies established by the registrant of imported medical devices,…
Comments are being accepted until 3 March 2025 on a proposal for a Resolution that provides for the use of health risk management criteria and monitoring of company compliance for the purposes of initially granting or renewing the Certificate of…
A period of public consultation has been held on draft Mexican Official Standard PROY-NOM-241-SSA1-2024, Good Manufacturing Practices for Medical Devices1. The purpose of this draft standard is to establish the minimum requirements for the processes of design, development, manufacturing, storage…
New guidance (SUR-G0053-1) has been issued1 in the form of a frequently-asked-questions document to explain to in-house manufacturers of medical devices and in vitro diagnostic medical devices (IVDs) about the requirement to notify the Health Products Regulatory Authority of their…
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…
Final guidance entitled Remanufacturing of Medical Devices has been published by the Food and Drug Administration to help clarify whether activities performed on devices are likely ‘remanufacturing’ as opposed to ‘servicing’1,2. The guidance also clarifies existing regulatory requirements for remanufacturers…
The Association for the Advancement of Medical Instrumentation (AAMI) Technical Information Report (TIR) 48: 2024, Quality Management Systems (QMS) Recommendations on Application of the U.S. FDA’s cGMP Final Rule on Combination Products1, is designed to assist manufacturers with meeting the…
As reported previously in the Journal, all non-notified Class C and D medical devices that were under mandatory registration moved to the licensing regime with effect from 1 October 20231 and now require a manufacturing/import licence to be placed on…
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…
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,…
Three new documents pertaining to Good Manufacturing Practices (GMP) for medical devices have been published by the Ministry of Food and Drug Safety: Medical Device Manufacturing and Quality Management (GMP) Review Casebook (Guide-1316-01)1, dated 15 November 2023, which introduces…
A period of public consultation has been held on a draft Announcement1 of the Ministry of Public Health regarding the production of medical devices exempted according to Section 27(8) of the Medical Device Act B.E. 2008. The production of medical…
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…
The format of establishment registration certificates for medical device manufacturers and importers has been amended. The establishment registration certificate for medical device manufacturers will follow the format of the newly amended Form B.S.P.11, while the establishment registration certificate for medical…
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…
Medical devices that have been manufactured up to five years before their date of registration with the Brazilian Health Regulatory Agency (Anvisa) may now be imported into Brazil1, subject to the presentation (at each import process) of a declaration issued by…
The Supplement for Medical Devices 5.0 to the Mexican Pharmacopoeia has been published1. This Supplement includes the specifications and methods of analysis and/or testing for medical equipment, software (newly added), prostheses, orthoses, functional aids, diagnostic agents, materials and substances for…
Official Mexican Standard NOM-241-SSA1-2021, Good manufacturing practices for medical devices [GMP], entered into force on 20 June 2023, 18 months after its publication in the Official Gazette of the Federation1. The purpose of this standard is to establish the minimum…
The Central Drugs Standard Control Organisation has reminded stakeholders that all non-notified Class C and Class D medical devices that are currently under mandatory registration will come under the licensing regime with effect from 1 October 20231. From this date, these…
Introduction Three dimensional (3D) printing offers endless possibilities for cost effectively accelerating the design, production, and delivery of patient-matched medical devices for enhancing and saving lives. Also known as additive manufacturing, 3D printing has been around for decades. However, recent…
Comments have been solicited on the following proposed amendments to the Korean Standards of Medical Device Good Manufacturing Practices (KGMP)1: reclassification of medical device product group; modification of the required dossier for documentation review; complete transfer of KGMP audit…
As required by the 21st Century Cures Act, the Food and Drug Administration (FDA) has published a list of alternative or streamlined mechanisms1 for complying with the current Good Manufacturing Practice (cGMP) requirements for combination products. In response to comments…
Guiding Opinions have been issued to help local drug regulatory authorities carry out better supervision of medical device manufacturing and operations under the medical device registration system1. These Guiding Opinions will come into force on 1 January 2023. The Guiding…
Regulatory authority The Ministry of Health, Drug and Food Control (MoH), through its Pharmaceutical and Herbal Medicines Control and Registration Administration, is responsible for medical device regulation in Kuwait. It oversees the evaluation, classification, registration and licensing of all medical…
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…
Resolution RDC No. 687/2022 specifies the inspection programmes and criteria for the granting or renewing of the certification of Good Manufacturing Practices (GMP) for medical devices1. The Resolution entered into force on 1 June 2022 with a transition period of…
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 Ministry of Food and Drug Safety (MFDS) has partially revised its Law No. 18446 with respect to medical device manufacturing licence renewals1. The first amendment relates to the expansion of the scope of exemption from submission of materials (Article…
Amendments have been proposed1 to the Standards of Medical Device Good Manufacturing Practices by the Ministry of Food and Drug Safety. Primarily, the proposal would mean that a Good Manufacturing Practice (GMP) change audit would not be required for a…
A final list has been published of medical devices that are prohibited from contract manufacturing1. This final list is shorter than the 22 medical devices that were proposed2 for inclusion: implantable pacemaker; implantable cardiac contractility regulator; implantable circulatory auxiliary…
The Measures for the Supervision and Administration of the Production of Medical Devices (Order No. 53)1 and the Measures for the Supervision and Administration of the Distribution of Medical Devices (Order No. 54)2 have been promulgated and entered into force on…
Salvadoran Technical Regulation RTS 11.03.03:22, Medical devices. Good manufacturing practices for medical devices and verification manual, has been developed to establish the principles and guidelines for Good Manufacturing Practices (GMP) that regulate all procedures involved in the manufacture of medical…
Resolution RDC No. 665 of 30 March 2022 contains provisions on Good Manufacturing Practices (GMP) for medical devices and in vitro diagnostic (IVD) products and comes into force on 2 May 20221. This Resolution incorporates into Brazil’s national legal system…
Resolution RDC No. 606/2022 updates the extraordinary and temporary criteria and procedures for certification of Good Manufacturing Practices (GMP) for registration and post-registration changes of medicines, supplies and health products1. This Resolution revokes Resolution RDC No. 346/2020. Resolution RDC No.…
