• 2021-08-02 04:21:25

In December 2020, MDA published the 2nd edition of the guidance document on the classification system of in-vitro diagnostic (IVD) medical devices. Compared to the 1st edition, this has a more solid and structured explanation for each classification.

• 2021-08-01 14:48:08

TGA's inclusion process for Class I in vitro diagnostic (IVD) medical devices in the Australian Register of Therapeutic Goods (ARTG) changed on 4 December 2020. This follows similar changes made on October 1, 2020, for Class I non-measuring, non-sterile medical devices. This article outlines the key changes about including Class I medical devices and Class 1 IVD medical devices in the ARTG.

• 2021-05-22 03:15:45

Thai FDA has publicized a series of regulations for Listing Medical Device (Class 1), fulfilling the completion of the transition from policy-based classification to risk-based classification. This marked a milestone for both establishments and the Thai FDA team.

• 2021-04-26 02:13:50

Health Sciences Authority (HSA) published “Medical Devices Product Classification Guide” draft comments. This document aims to help the stakeholders in determining whether a product is a medical device or not.

• 2021-02-19 08:45:21

NMPA has introduced important adjustments to the contents of the Classification Catalogue of Medical Devices for 28 classifications of medical devices, including management of 15 classifications of medical devices and catalogue contents of 13 classifications of medical devices.

• 2020-11-27 02:19:08

Compared to domestic and foreign listed products, novel medical devices with new designs, materials or processes, or scope of application and pose a high risk to humans should be approved for clinical trials before the trials can be conducted in China.

• 2020-11-27 01:49:09

The previous regulation: “Products under classification I.0007 Hyaluronic Acid Implants required to conduct PSUR” is ceased since July 23rd, 2020. TFDA has re-evaluated the product safety and decided that each medical device under this classification may be reviewed individually for the necessity for conducting Periodic Safety Update Report (PSUR).

• 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.

• 2020-09-15 09:09:58

After a lengthy discussion, the U.S. Food and Drug Administration (FDA) released the final determination of the exempt list for the premarket notification (510 k). The exemption list is immediately in effect after July 22nd, 2020. We summarize the Agency's final determination information from the FDA for you.

• 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.