• 2020-08-13 09:07:56

Covid-19 pandemic has changed the landscape of the medical device markets drastically. In this article, we explore the shifts in supply and demand and bring up an overview of the key areas that have either been positively or negatively impacted.

• 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 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.

• 2020-08-11 05:46:22

To standardize and guide medical device registrants to prepare periodic risk evaluation reports, NMPA has released a guidance to illustrate the required information and format in this special “PSUR”.

• 2020-08-11 05:46:22

PFDA adjusted some transactions that usually requires face to face interactions. However, PFDA reminded that post-marketing surveillance activities for all medical devices will be continue.

• 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 Medical Device Division (MDD) Hongkong will continue the trial scheme to simplified application and approval process of Class II/III/IV general medical device listing applications with established support on proven safety and performance.

• 2020-07-16 07:22:55

Taiwan’s FDA has issued a Good Distribution Practice Guideline for Medical Devices. With the new guidelines getting into force in the near future, relevant distributors will be required to obtain a GDP certificate before they can legally distribute medical equipment.

• 2020-06-16 08:03:29

NMPA released the Draft Revision of Guidance of Software for Medical Device Registration, which increased the scope of application, while paying more attention to the review of technical documents.

• 2020-06-16 08:03:29

PFDA released updated guidelines for the importers and manufacturers of PPEs, ventilators, and respirators in relation to the COVID-19 situation.