JNM Global

Global Approval Partner

JNM Global/Medical Device 121

Malaysia MDA, Regulatory approach on the use of expired EC Certificate for new medical device registration

On June 5, 2025, the medical device Authority (MDA) of Malaysia announced a revised regulatory approach regarding the use of expired EC certificates for the purpose of new medical device registration in Malaysia. CE Marking (EC Certificate) issued under EU Directives 90/385/EEC, 93/42/EEC, and 98/79/EC continues to be recognized by the MDA as a valid form of approval for conformity assessment in..

Singapore HSA, Launch of the New Medical Device Regulatory e-System SHARE Portal

On May 21, 2025, Singapore’s Health Sciences Authority (HSA) announced that it will replace the current medical device registration submission system, MEDICS, with a new one-stop digital portal for regulatory services, SHARE, starting July 14, 2025. This system transition will affect all ongoing and upcoming registration applications for medical devices. To ensure a smooth transition, stakeholde..

China NMPA, List of Medical Devices Exempt from Clinical Evaluation (2025)

On May 12, 2025, the National Medical Products Administration (NMPA) of China revised and announced the list of medical devices exempt from clinical evaluation to facilitate medical device registration and management. The clinical evaluation exemption list was originally established in 2023 and updated in 2025. It announces categories of medical devices for which clinical evaluation can be waiv..

Malaysia MDA, Conformity assessment procedure for medical devices approved by the authorities of other recognized countries

On March 26, 2025, the Malaysian Medical Device Authority (MDA) issued Circular 1/2025, which outlines the conformity assessment procedure for medical devices approved by recognized foreign regulatory authorities. The MDA recognizes the approvals for medical devices issued by the following recognized foreign regulatory authorities: Competent AuthorityApprovalsEU / EU NBFor Class B via EC certi..

China NMPA, Announcement of the Quality Management Standards for Online Sales of Medical Devices

On April 28, 2025, the National Medical Products Administration (NMPA) of China released regulations outlining the basic requirements for the quality management of online sales of medical devices. These regulations specify the requirements that apply to online sellers and e-commerce platform operators selling medical devices online in China. The main contents of the regulation are as follows: ..

Thailand TFDA, Announcement of A draft of the new labeling and IFU requirements for medical devices

On March 18, 2025, the Thai Food and Drug Administration (TFDA) released a draft amendment regarding the labeling standards, methods, and conditions for medical devices. Manufacturers, importers, license holders, and those who have reported registration details of medical devices are required to prepare medical device labels and IFU in accordance with these regulations. The label for medical d..

Mexico COFEPRIS, Announcement of the Revised Good Manufacturing Practices (GMP) for Medical devices

On April 4, 2025, Mexico’s COFEPRIS announced the revised version of the Good Manufacturing Practices for medical devices (NOM-241-SSA1-2025). This standard establishes the minimum requirements for the design, development, manufacturing, storage, and distribution processes of medical devices. For medical device registration, the submission of GMP certification documents is required for devices ..

Malaysia MDA, Online transition of the product classification application process

In Malaysia, the classification of medical device must be carried out by the manufacturer in accordance with the prescribed manner, based on the level of risk, intended use, and the vulnerability of the human body as stated in Section 3(1) of Act 737. In the event of a dispute between the manufacturer and the Conformity Assessment Body(CAB) regarding the classification of a medical device, the m..

AU TGA, Guidance issued on UDI regulations for medical devices

On March 24, 2025, Australia’s Unique Device Identification (UDI) regulatory framework came into effect to enhance patient safety and improve the efficiency of the regulatory system, including the management of post-market safety activities such as recalls. In line with this, the Therapeutic Goods Administration (TGA) released guidance on UDI requirements and compliance with identification timel..

EU IVDR, Revised Guidance on Classification Rules In Vitro Diagnostic Medical Devices (IVDR)

On Mar 18, 2025, the European Commission (EC) published the revised guidance on classification rules for In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746, under MDCG 2020-16 rev.4.  The purpose of this document is to provide guidance to manufacturers, Notified Bodies (NB), and healthcare institutions on how to classify In Vitro Diagnostic Medical Devices before placing them on..