• 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.

• 2021-02-19 08:35:07

Starting from January 1, 2021, medical devices specially identified by the NMPA should register in the eRPS system, along with UDI-DI related information.

• 2021-01-19 02:59:53

Hong Kong boasts a wealthy and sophisticated medical device market. With the medical technology industry being one of the major driving forces for the country’s booming economy, in this edition of QT Analysis, we delve deep into the reasons why it is a booming medical device market in Asia and how you shouldn’t miss out on the great business opportunities it offers.

• 2021-01-20 01:20:07

Starting 25th August 2020, TGA has adopted new medical device definition and a number of other related definitions in the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations), as well as minor amendments to the requirements for system or procedure packs in the Regulations.

• 2021-01-19 03:44:00

HSA has introduced the regulatory requirements for non-contact/contactless thermometers. These devices are intended to be used for fever screening and prove significant, especially during this pandemic. HSA has shared different guidance pertaining to classifying, manufacturing, importing or supplying this device in Singapore, along with safe usage.

• 2021-01-19 03:20:16

Indonesia's Ministry of Health has explained about the scenario of "Double Agent" at a seminar that was held recently. "Double Agent" is the term used to refer multiple authorizations for the one product brand originated from the same Principal or Manufacturer to the several Medical Device Distributors.

• 2021-01-19 02:48:31

A new policy initiative recently agreed between the Hong Kong and China Mainland governments proposes to allow Hong Kong-listed medical devices and drugs to be sold to Hong Kong-owned medical institutions within the Greater Bay Area without prior NMPA registration.

• 2021-01-19 02:38:54

NMPA's newly released Guiding Principles explain the general, principled and forward-looking requirements for the application of real-world data of medical devices in clinical evaluation.

• 2021-01-08 02:18:25

2021/1/13 (三) 16:00 (GMT+8)，我們很榮幸邀請到Mr. Arkan Zwick (Regulatory Affairs Director of Croma) 與Ms. Alexandra Baer-Zwick (Head of RA-GCD, deputy QPPV of Croma) 為我們分享歐盟醫療器材法規概要與發展。

• 2020-12-24 11:05:44

TFDA has announced a new draft about Good Distribution Practice (GDP). This practice requires distributors who import and/or sell medical devices or who hold medical device registration licenses (license holders) to set up a good distribution system. This is to ensure their quality and integrity are constantly maintained. In this article we have listed important points for distributors to comply with the GDP guideline, throughout the process of importation, transportation, storage, sale and post-market services competent authority and obtaining a distribution license.