• 2020-10-21 02:06:33

CDSCO has issued draft of new risk-based classification lists for previously non-notified general and IVD medical devices, in order to clarify regulatory pathways and requirements.

• 2020-08-13 02:35:55

TFDA is now collecting comments and suggestions for the drafting of “Regulations Governing Delegation or Commission of Medical Devices Test” (collecting deadline: 2020/09/07). This article presents a closer look of this upcoming regulation.

• 2020-08-11 05:46:22

The Indonesian Ministry of Health has published a guidebook for Grouping of Medical Devices and In Vitro Diagnostic Devices recently. Indonesia has 6 types of grouping, namely: Single, System, Family, IVD Test Kit and IVD System.

• 2020-08-11 05:46:22

The Indonesian Ministry of Health has issued a guidebook, which will be explained the flow of medical device services specifically for medical and household health supplies used for handling Covid-19.

• 2020-06-16 08:03:29

TFDA is now collecting comments and suggestions for the draft of “Regulations on Good Clinical Practice for Medical Devices”. This article provides a comparison between the current specification and the upcoming regulation.

• 2020-06-16 05:19:05

To ensure the safety and efficiency of adopting human factors/usability engineering evaluation while manufacturer developing medical devices, this guidance provided an overall concept and guide, including product design, development, registration, and post-market related matters.

• 2020-06-11 10:00:48

Health Sciences Authority (HSA) is informed to the increased demands for medical products relevant to COVID – 19. Various establishments have considered 3D printing (3 – DP) to address the issue of limited supply of medical products.

• 2020-06-11 09:48:40

NMPA publishes a clear guidance to regulate the raw material change in medical device. In this guidance, it points out three major changes on material component and how to perform the risk assessment on raw material change.

• 2020-06-11 09:41:54

NMPA drafts a new guidance document of human factors (Usability) for medical device, the Class II and Class III devices are applicable once implementation. Now NMPA seeks for public comment.

• 2020-05-12 08:20:00

A new guidance document on this has been issued with the requirements to be followed: All orphaned, obsolete and discontinued medical device still in active use must now be notified with MDA.