This article proposes that Medical Device Manufacturers embark on a journey through Europe, America and Asia to discover the main deadlines that regulatory professionals will face by the end of the year.
European Union
Manufacturers marketing Medical Devices in the European Union must be prepared for the most important and challenging deadline of the year: May 26, 2024.
Specifically, by May 26 the manufacturer must submit a conformity assessment following Annex VII, point 4.3, first paragraph of MDR (EU) 2017/745.
Class III custom-made implantable Medical Devices may be placed on the market without a corresponding certificate until May 26, 2026, provided the manufacturer has submitted an application for conformity assessment to a Notified Body by May 26, 2024.
All other custom-made Medical Devices may be placed on the market after the manufacturer has drawn up the declaration required by Annex XIII of the MDR.
The application for conformity assessment should include the manufacturer’s Quality Management System (QMS) documentation. This means the manufacturer must have set up an MDR-compliant QMS as in Article 10 (9) by May 26, 2024.
Canada
An important deadline, which is repeated every year, concerns manufacturers holding the Medical Devices Establishment Licence (MDEL). Specifically, they must apply for a licence revision by April 1, 2024. If licensed activities have ceased and you no longer need an MDEL after April 1, 2024, you still need to send a cancellation notice.
One big news is that for the first time, the distributor shall also have a Medical Devices Establishment Licence (MDEL).
USA
Last October 2023, the Center for Devices and Radiological Health (CDRH) published a list of new guidelines and old documents for a review scheduled for the 2024 fiscal year, which, as a reminder, began in the US on October 1, 2023, and will end on September 30, 2024.
The list of documents to be revised by September 30, 2024, is very voluminous and includes documents from the years 1984, 1994, 2004, and 2014 that touch on various medical topics, including artificial intelligence, cybersecurity, electroMedical Devices, biocompatibility and certification processes.
Brazil
Anvisa has announced updates to in vitro diagnostic medical device (IVD) legislation through the publication of IVD Legislation as Resolution (RDC) 830/2023, which will come into force on June 1, 2024. RDC 830 aims to consolidate the regulation of IVDs by bringing it closer to the regulation governing Medical Devices RDC 751/2022.
Furthermore, an innovation compared to the previous regulation is that documents can be submitted in English, Spanish or Portuguese.
China
In China, an important date is September 15, 2024, the date by which manufacturers must comply with the new standards published by the Chinese authority, the National Medical Products Administration. In particular, the latter has approved and published 45 new standards in the field of Medical Devices, of which six will be mandatory, while the others are only voluntary.
Philippines
As announced by the Center for Device Regulation, Radiation Health and Research (CDRRHR) of the Philippines, as of April 1, 2024, the importation of all Class B, C and D Medical Devices without Certificate of Medical Device Notification (CMDN) or Certificate of Medical Device Registration (CMDR) will be prohibited. Manufacturers of class B, C and D devices with expiring CMDNs shall proceed with renewal via CMDR application within six months of expiry.
These are just some of the deadlines and activities to be addressed in the coming months at the European and international levels. To receive reliable legislative, prescriptive and regulatory updates, necessary to keep your list of external source documents up-to-date, have a look at the RegToDate service.
For concrete support in meeting regulatory requirements, contact us: at sales@thema-med.com.
