• 2023-06-28 07:48:07

This guidance aims to provide a clear understanding of what changes to design or intended purpose would be considered 'significant'. It also provides several flowcharts in order to facilitate a harmonised judgement of the significance of a change.

• 2023-06-28 07:35:36

HSA would like to consult the industry/stakeholders regarding updates and revisions of GN-14 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices (R3). The key update includes clarification notes on the classification of control materials and software, also clarifications to the risk classification rules 1-5. The consultation period is open from 2-30 May 2023 through email to HSA.

• 2023-06-28 07:24:11

The Food and Drug Administration (FDA) has recently released guidance aimed at streamlining the premarket notification (510(k)) submissions for peripheral percutaneous transluminal angioplasty (PTA) and specialty catheters. This guidance provides manufacturers and FDA staff with comprehensive recommendations to ensure regulatory compliance and enhance the safety and effectiveness of these medical devices

• 2023-05-24 07:24:05

In order to standardize the management of radiofrequency aesthetic devices, the CMDE issued the “Guidance for the Registration and Review of Radiofrequency Aesthetic Devices”.

• 2023-03-27 09:59:19

This guidance addresses the classification of IVDs and provides clarification rules as set out under Annex VIII of the IVDR.

• 2023-02-23 01:23:58

Thai FDA has published a guidance, which aims to assist the justification status of Software as Medical Device (SaMD) as well as its risk classification for Thai FDA registration.

• 2023-01-19 05:51:33

This guidance is to assist manufacturers to implement the legal requirements related to the Periodic Safety Update Report (PSUR), which has been introduced in Article 86 of the MDR. This guidance provides the detailed information of the PSUR requirements and the related templates.

• 2022-12-27 08:46:16

This guidance is written for AR, manufacturers and other economic operators and provides clarification on relevant requirements under the Regulations.

• 2022-12-27 05:37:15

The Malaysia Medical Device Authority (MDA) published the updated Sixth Edition Guidance Document, “Requirement for Labelling of Medical Device” (MDA/GD/0026), on November 21, 2022. MDA has made a few changes, respectively. MDA/GD/0026 is intended to assist manufacturers and authorized representatives with guidance on the content of medical device labelling. Labelling is used to both identify particular medical devices and to convey safety and performance-related information to patients or users of medical devices.

• 2022-11-29 02:42:41

The Medical Device Authority (MDA) updates the guideline for Licensing for Establishments. The establishment must comply to Medical Devices (Duties and Obligations of Establishments) Regulations 2019 that stipulates the post marketing requirements of medical devices. The Medical Device Authority (MDA) created this guidance document to assist the healthcare sector and the industry in their efforts to comply to the Medical Device Act's (Act 737) laws and requirements.