• 2020-02-14 03:49:35

In the other word, a marketing authorization license of medical devices containing mercury that has an expiry date later than December 31, 2018 will be automatically not valid after that date and the owner of a marketing authorization license must surrender the marketing authorization back to the Ministry of Health of Indonesia cq.

• 2020-02-14 04:21:46

A research conducted by BMI Espicom showed that the scale of the global medical device market is expected to reach US$38.91 billion in 2019, of which Japan has the world’s second largest medical device market, second to United States. Global medical equipment manufacturers in addition to Europe and the United States well-known manufacturers (GE, Medtronic, Johnson & Johnson, etc.),

• 2020-02-14 04:17:45

During the early week in May, the Hainan Government has issued a further notice for “the Supervision Regulation of Emergency Medical Devices in Hainan International Tourism Area”. This is applicable to medical devices that are urgently needed for clinical purposes (hereinafter referred to as "emergency devices").

• 2020-08-06 09:09:52

• 2020-02-14 07:32:41

The Council decides to suspend the implementation of Clause 11 of the Medical Device Registration and Management in the Hainan tourism area. In order to support this suspension, CNDA has released a temporary Order, entitled “The Supervision Regulation of Emergency Medical Devices in Hainan International Tourism Area”. The scope of this Order includes all medical devices that are urgently needed for clinical purposes, operation conditions, and a

• 2020-02-14 07:27:45

Thai FDA announces that they will modify the Medical Device Act and will be adopting the international risk classification method (Class I-IV) in order to comply with the ASEAN Agreement on Medical Device Directive.

• 2020-02-14 04:23:23

TFDA Department of Medical Device and Cosmetics is set to move to a new office starting on April 30, 2018. The new office will be located at the Alley 12, 2nd Section of Yan Jiu Yuan Road, Nangang District, Taipei City.

• 2020-02-14 07:42:08

On 30th of November 2017, following recommendation from the Advisory Board, Thai FDA had announced four new checkpoints which regulate importation and exportation of medical devices. The new checkpoints are located in four different provinces as follows:

• 2020-02-14 07:41:28

The Thai Medical Device Control Division has amended the application form for medical device advertising following the Thai FDA announcement on 19 January 2018. It is appropriate to report complete and clear information to monitor the impact of disclosure.

• 2020-02-14 07:51:46

The regulatory body for medical devices is Division of Medical Devices and Cosmetics under Taiwan Food and Drug Administration (TFDA). The important legal rules that govern Medical Device Affairs are the Pharmaceutical Affairs Act and the Regulations for Governing the Management of Medical Device.