• 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 08:52:43

PFDA presented a draft of the updated guidelines on obtaining a special permit for restricted use of unregistered drug and medical device products. In addition to previous patient conditions laid out by previous regulations, this new guidance widens the product scope to vaccines and the diseases to include those that may result in the patient's permanent disability.

• 2023-03-27 08:27:31

Thai FDA announces 'Thailand FDA - WHO Collaborative Registration Procedure (CRP) for in vitro diagnostics (IVDs)', an expedited medical device registration program aimed at reducing the time required for manufacturers and importers to register their products. The program officially commenced on December 28, 2022, onward.

• 2023-02-23 01:28:49

A consultation window for framework and implementation of the Cybersecurity Labelling Scheme for Medical Devices [CLS(MD)] was announced to be open for the public from January 23 to March 3, 2023.

• 2023-01-19 06:04:35

The NMPA drafted the <Announcement on the Third Batch of Implementation of the UDI of Medical Devices (Draft for Comment)> and is now soliciting opinions publicly.

• 2022-12-27 08:57:20

The Center for Medical Device Evaluation (CMDE) has issued the “List of Mandatory Standards Applicable to Medical Devices” for applicants to determine the mandatory standards which apply to a specific product.