• 2023-11-20 02:19:57

This guidance provides clarifications on which specific regulatory considerations apply when the hardware or hardware component are classified as a medical device or an accessory to a medical device.

• 2023-10-20 05:56:00

The US FDA issued a draft guidance for medical devices that have relation to Weight Loss. The purpose of this guidance is to provides recommendations for both clinical and non-clinical testing to support premarket submissions.

• 2023-07-21 03:42:44

NMPA issued <The appendix to the Medical Device Operation Quality Management Standard: Guidance for On-site Inspection of Quality Management of Enterprises Providing Medical Device Transportation and Storage Service>.

• 2023-07-21 02:46:26

The Medical Device Authority (MDA) published the Third Edition Guidance Document, "On Guidance on Medical Face Mask and Respirator", on May 19, 2023. This document is intended to give clarity on medical face masks and respirators regulated by the Medical Device Act (Act 737). This document applies to establishments, healthcare facilities, and the general public who deal with medical face masks and respirators.

• 2023-06-28 09:43:30

Center for medical device evaluation (CMDE) revised "Guidance for Registration of Intense Pulsed Light Equipment" and "Guidance for Registration of Ophthalmic Optical Instrument".

• 2023-06-28 09:38:06

This document aims to ensure that the summary of the clinical investigation report presents information about the design, conduct, analysis, and results of the clinical investigation in terms and in a format that are easily understandable to the intended user of the medical device.

• 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”.