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This is a rare example of a public-private partnership, since the industry will not only be asked to share the available data with the government, industry representatives will also be invited to participate in the data review and decision making for the target substances. On the part of the Japanese government, several authorities are participating in the project, including the Ministry of Health, Labour and Welfare (MHLW), the Ministry of Economy, Trade and Industry (METI), the Ministry of the Environment (MOE), Japan's National Institute for Occupational Safety and Health (JNIOSH) and the National Institute of Technology and Evaluation (NITE).

While there is no obligation for businesses to actually include the same information on their labels and SDSs for a substance, GHS classification results by the government are intended to be used as a reference for businesses to create compliant labels and SDSs. In Japan, however, there are three main chemical laws (ISHL, PRTR and PDSCL)* that all refer to GHS-compliant SDSs and labels, each with different regulatory requirements. GHS-compliant SDSs and labels need to comply with JIS Z 7252 and 7253, based on GHS (Rev.6). The authorities are preparing an update to GHS (Rev.9).

The deadlines communicated on 18 April 2023 for industry participation are as follows:

• Declaration of intent (‘enrollment’): by 30 June 2023
• Submission of data and information: by 31 October 2023

The list with the 157 target substances for 2023 can be found on the official website of the National Institute of Technology and Evaluation (NITE).

*       ISHL: The Industrial Safety and Health Law

PRTR: The Pollutant Release and Transfer Register

PDSCL: Japan's Poisonous and Deleterious Substances Control Law (Japanese only)

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According to Regulation (EU) 2023/607 of 15 March 2023 amending Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices,  certificates issued by notified bodies under Directives 90/385/EEC and 93/42/EEC (AIMDD and MDD) after 25 May 2017 and still valid before 26 May 2021 shall remain valid after the end of the period indicated on the certificate until:

• 26 May 2026 for class III custom-made implantable devices;
• 31 December 2027, for all class III devices, and for class IIb implantable devices except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors;
• 31 December 2028, for class IIb devices other than those mentioned above, for class IIa devices, and for class I devices placed on the market in sterile condition or having a measuring function.

However, this only applies on the condition that the devices continue to comply with the AIMDD or MDD and there are no significant changes in the design and intended use. Furthermore, no later than 26 May 2024, the manufacturer (or the authorised representative) has lodged a formal application with a notified body in accordance with Annex VII MDR for conformity assessment, and the notified body and the manufacturer have signed a written agreement for the conformity assessment in respect of the device covered by the expired certificate or in respect of a device intended to substitute that device before the date of expiry of the certificate.

Another requirement for the extension of the transition period is the establishment of a quality management system by the manufacturer no later than 26 May 2024, in accordance with MDR Article 10(9).

In addition, devices placed on the market in accordance with AIMDD and MDD prior to 26 May 2021 or in line with Directive 98/79/EG (IVDD) prior to 26 May 2022 may continue to be made available on the market or put into service. This provision removes the “sell-off” period for medical devices and in vitro diagnostic medical devices.

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The key elements of the proposal are:

• For medical devices covered by a certificate or a declaration of conformity issued before 26 May 2021, the transition period to the new rules is extended from 26 May 2024 to 31 December 2027 for higher risk devices and until 31 December 2028 for medium and lower risk devices. The extension will be subject to certain conditions, so that only devices that are safe and for which manufacturers have already taken steps to transition to the rules provided for by the Medical Devices Regulation will benefit from the additional time.
• The proposal introduces a transition period until 26 May 2026 also for class III implantable custom-made devices, giving their manufacturers more time to obtain certification by a notified body. Also in this case, the transition period is subject to the application of the manufacturer for a conformity assessment of devices of this type before 26 May 2024.
• To reflect the transition periods put forward by these amendments, the proposal extends the validity of certificates issued up until 26 May 2021, the day when the Medical Devices Regulation became applicable.
• The Commission also proposes to remove the ‘sell-off' date currently established in the Medical Devices Regulation and in the In Vitro Diagnostic Medical Devices Regulation. The ‘sell-off' date is the end date after which devices that have already been placed on the market, and remain available for purchase, should be withdrawn. Removing this ‘sell-off' date will ensure that safe and essential medical devices that are already on the market remain available to healthcare systems and to patients in need.¹