• 2023-04-25 01:59:50

Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amends the MDR and the IVDR as regards to the transitional provisions for certain medical devices and in vitro diagnostic medical devices.

• 2023-04-25 01:51:22

The Indonesia Ministry of Health issues circular letter no HK.02.02/E/359/2023 that regulates new requirements for the labelling of Rapid Diagnostic Antigen COVID-19 Nasal Swab Method with Self-Testing Claim.

• 2023-04-25 01:46:23

The Japanese Industrial Standard of EMC (JIS T0601-1-2) has been amended.

• 2023-04-25 01:40:47

The MDA published the Second Edition Guidance Document, “Classification Of Rehabilitation, Physiotherapy And Speech Therapy Device” (MDA/GD/0061), on March 08, 2023. This document is directed to give manufacturers and authorized representatives (AR) an appropriate guideline on the classification of rehabilitation, physiotherapy, and speech therapy products. This guidance document classifies a number of products used for rehabilitation, physiotherapy, and speech therapy as medical devices or non-medical devices respectively, based on the manufacturer's stated intended purpose.

• 2023-04-24 09:49:39

This guidance document describes the requirements and notification process for the applicant to get approval from the Authority prior to the importation and/or market placement of custom-made medical devices.

• 2023-04-24 09:37:45

On March 31, 2023, PFDA has once again extended the application period for one more year for medical device products that were previously considered non-registrable, which currently fall under AMDD risk class B-D. PFDA cites the risk of disrupting the supply chain that may negatively impact the quality of the healthcare system in the country.

• 2023-03-27 10:02:31

The UDI of specific categories of class II medical devices is going to be implanted. In this announcement, the list of medical devices which require a UDI is provided and the relevant progress and requirements are announced.

• 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.

• 2023-03-27 09:42:05

A Presidential Decree No. 6/2023 concerning Halal Certification for Drugs, Biological Products and Medical Devices, which is based on Government Regulation No 39/2021 concerning Halal Product Implementation, is issued. This decree will further regulate the halal implementation of medical devices in Indonesia.

• 2023-03-27 09:16:15

The Medical Device Authority (MDA) published the Fifth Edition Guidance Document, "Guideline for Registration of Drug-Medical Device and Medical Devie-Drug Combination Products", on January 03, 2023. This document is intended to provide information on how to apply for an endorsement letter, post-approval changes/variation applications for ancillary components, adverse drug reactions and incident reporting for the registered combination product.