• 2020-06-16 08:03:29

PMDA has announced of organizational restructuring of Office of International Programs, aiming strengthening of cooperative relationship with Asian countries.

• 2020-06-16 07:59:23

Amid COVID-19, Japan's Ministry of Health, Labor and Welfare temporarily allows single-use parts of air ventilator to be reused under certain condition.

• 2020-06-16 07:38:56

In China, AI medical devices are evolving, and its regulatory system is also being developed rapidly. We have researched applications of AI to medical device and clinical assistance in China, as well as, outstanding Chinese AI companies and related AI products.

• 2020-06-16 07:02:42

COVID-19 outbreak causes the need for medical devices to be in very high demand. Therefore, IAPI (Association of Indonesian Procurement Experts) together with PERSI (Association of Hospitals throughout Indonesia) has provided an emergency medical equipment information system to handle the procurement and donation throughout Indonesia.

• 2020-06-16 06:31:23

Ministry of Public Health Announcement regarding the Standard of Medical Device that Manufacturer or Importer must Comply 2020, is one of the countless Thai FDA Regulatory updates in June. Manufacturer and Importer may refer to this announcement as collection of guidance which standard of listed Medical Device can be denote to.

• 2020-06-16 05:58:49

Ministry of Finance Decree ( PMK-34/PMK.04/2020) stated that import of goods for the purposes of handling the COVID-19-related medical products are granted with customs and / or excise and taxation facilities. Applicant could apply the exemption through INSW website (http://www.insw.go.id/). This policy is started from 17 April 2020 until further date set by The National Disaster Mitigation Agency (BNPB).

• 2020-06-16 05:48:04

This is a specific pre-clinical testing guidance for products classified under Soft (hydrophilic) contact lens in Taiwan. The guidance provided a clear standard of (1) product description and specification, and (2) safety and performance data.

• 2020-06-16 05:36:31

This is a specific pre-clinical testing guidance for products classified under Powered wheelchair in Taiwan. The guidance provided a clear standard of (1) product description and specification, and (2) safety and performance data. The overall pre-clinical test data should include inspection specifications, methods, original records, and results.

• 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.

• 2020-06-16 05:04:48

Thailand is presently at the PHASE 3 transition, where businesses are reopening , Qualtech presents collection of the regulatory updates from ThaiFDA, in relation to COVID-19 kit outbreak.