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On March 20, 2024, the Agência Nacional de Vigilância Sanitária (ANVISA) officially extended the validity of Brazilian Good Manufacturing Practice (B-GMP) certificates to four years for manufacturers participating in the Medical Device Single Audit Programme (MDSAP), and this extension took effect on April 1, 2024. Specifically, ANIVSA published Resolution RDC 850/2024 amending Article 8 [...]
ANVISA -Brazilian Regulatory Authority - published the RDC 665/2022 (entered into force last 2May 2022). This resolution rewrites the BGMP (Brazilian Good Manufacturing Practices) requirements for Medical Devices and IVDs, becoming now the reference point for the adaptation of the Quality Management System of Manufacturers who place their devices on the Brazilian territory, both with [...]
Aiming to harmonize the Korean Good Manufacturing Practice (KGMP) with the requirements of the ISO 13485:2016: 2016 Standard, the South Korean Ministry of Food and Drug Safety (MFDS) issued on October 1st, 2018 the Notification No. 2018 - 409 "Manufacture and Quality Control Standards for Medical Devices (Food and Drug Administration Notice 2016-156)". Through the [...]
We support the Quality Thanks to our long-term experience, we can fully assist you in the implementation of the Quality System for Medical Devices and Good Manufacturing Practice (GMP), in accordance with the requirements laid down in the regulation of the target Country. Some services: Pre-audit/orientative/gap-analysis for the verification of the Quality Management System (QMS) [...]
The design is excluded for some class I devices or when it is carried out by other subject responsible for it. If a manufacturer is responsible for some operations subject only to the 21 CFR 820 requirements (for example, if he acts as a Contract Manufacturer), he should only meet the requirements applicable to the [...]
GMP means “Good Manufacturing Practices”. The GMP requirements, defined by the US Food & Drug Administration, relate to all company’s operational aspects affecting directly or indirectly the final product quality. Therefore, not only on design and production activities, but also on all processes supporting the “Operations”. You just need to apply the quality system requirements [...]
As of June 3, 2024, it will be possible to place one's high-risk Medical Devices in Brazil, relying on authorisations from other selected countries worldwide. This path significantly accelerates registration procedures and can only be welcomed with enthusiasm by the industry. The important news has been formalised by ANVISA, the Brazilian Regulatory Agency, with [...]
On April 26, 2024, the International Medical Device Regulation Forum (IMDRF) published "Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices". This document establishes the harmonised essential principles to be observed in the design and manufacture of Medical Devices (MDs) and In Vitro Diagnostics (IVDs) to ensure the safety and [...]
April 1, 2024, represents a very significant date for the Medical Devices market in Canada. First, from this date, modified tariffs will come into force for applications, such as device registration, involving Medical Devices. In addition, holders of a Medical Device Establishment Licence (MDEL) shall apply for a review of their licence every year [...]
What is Quality System 21 CFR Part 820? FDA 21 CFR Part 820 is a regulatory framework governing the quality systems for devices regulated by the FDA in the United States, known as the Current Good Manufacturing Practice (CGMP). The CGMP specifications for Medical Devices are outlined in 21 CFR Part 820, finalized in [...]
On February 2, the FDA published the Quality Management System Regulation (QMSR) Final Rule on its official website, amending the current Good Manufacturing Practice (GMP) requirements of the Quality System Regulation (21 CFR Part 820) by incorporating ISO 13485:2016 by reference. This represents a very important step towards greater harmonisation of US regulations with the [...]
Last October 2023, the Food and Drug Administration (FDA) updated the Compliance Programme Manual on its official website, which covers inspections of medical device manufacturers to promote and continuously improve the quality, safety and efficacy of devices and thus meet the needs of patients and safeguard their health. The Mutual Recognition Agreement (MRA) between the [...]
Let's Take Care Beyond the Boundaries THEMA CORP. Services Contact THEMA provides strategic-regulatory consulting services to companies operating in the medical device, in vitro diagnostic medical device, and related regulated fields. THEMA aims to help its Clients to achieve their own marketing goals by using a [...]
On August 9, 2023, the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), the Mexican governmental body in charge of the regulation of Medical Devices, updated the Guía De Criterios Para Clasificación de Modificaciones de Registros Sanitarios de Dispositivos Médicos by defining types and impact of product or organisational changes on premarket registrations. The [...]
On 15 April, Health Canada published the Amending the Food and Drug Regulations and the Medical Devices Regulations (Recalls, Establishment Licences and Finished Product Testing) in Canada Gazette, stating that by 29 June 2023, Manufacturers, Importers and Distributors may submit comments on the Canadian regulatory agency's proposed updates to the Medical Device Regulation Directive (SOR/98-282) [...]
Regulatory Authority Food and Drug Administration (US FDA) Classification I, II, III Quality system A Quality System compliant with 21 CFR P art 820 et alter is required. Considering that, compared to previous versions of the same standard, the requirements of the latest version of ISO 13485:2016:2016 are closer to the Quality System Regulations [...]
News Latest news and updates about MDs and IVDs ALL NEWS Corporate Video Brexit News The UK has left the EU and the transitional period is about to end. find out more Swiss News Due to MDR (UE) 2017/745, Switzerland has [...]
Transition to MDR (EU) 2017/745 Certification Regulatory update Swiss - Exit: Requirements for marketing Medical Devices in Switzerland IVDR (EU) 2017/746 What will be the impact of MDR (EU) 2017/745 on EC MDD certificates in 'period of grace'? How to register radiation-emitting Medical Devices [...]
Japan’s Ministry of Health, Labour, and Welfare (MHWL) has updated its processes and procedures in order to officially accept MDSAP reports starting from 1st April 2022, as evidence of conformity of the quality management system required for Medical Devices registration procedures. OK MDSAP report starting from 1st April 2022 Please remember that the Medical Device [...]
IVDR Emergency Kit: the fastest solution to respond to the main obligations of the IVDR (EU) 2017/746. Experts Thema projected a solution to allow Economic Operators in the IVD sector to quickly and independently align with the main provisions of the IVDR (EU) 2017/746, saving time and costs. IVDR (UE) Emergency Kit is a sort of “toolbox” in [...]
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