• 2024-04-03 09:16:23

The Philippine Food and Drug Administration (PFDA) released an advisory on March 06, 2024 announcing that COVID-19 Medicines and Devices will no longer be VAT-exempt, effective 01 January 2024. This is due to the expiration of the VAT exemption provision in the CREATE Act.

• 2023-07-24 10:42:16

Congratulations to our first PhD internship program candidate!! Graduating with PhD degree!

• 2023-08-23 05:04:48

The US FDA has taken a significant step towards enhancing medical standards and knowledge sharing for improved healthcare. They have recently updated their Recognized Consensus Standards database to grant full recognition to ISO 22441:2022, a pivotal sterilization standard. Additionally, the FDA has included two Technical Information Reports (TIR), namely AAMI TIR104:2022 and AAMI TIR17:2019/(R)2020, demonstrating their dedication to advancing medical practices and spreading knowledge in the healthcare field.

• 2023-02-23 01:39:29

The Procurement Bureau of the Ministry of Health and the National Public Procurement Agency plan to expand E-purchasing access for private health facilities participating as National Health Insurance (in Indonesia known as JKN) providers for transactions of medical devices in the e-katalog starting from January 2023.

• 2022-06-30 11:51:47

Given the return and the increased popularity of in-person medical exhibitions, Qualtech has taken the opportunity to provide you with a sneak peek of the innovative medical device trends to be observed in ASEAN’s upcoming big medical exhibitions and fairs. This includes, among other fields, wearable technology, augmented reality for surgeon training and pre-operation planning, as well as virtual reality surgery with robotic and artificial intelligence assistance.

• 2022-01-26 11:18:16

Singapore pioneered the accelerated registration routes in ASEAN in 2018. As the region transitions into the implementation of the ASEAN Medical Device Directive, more countries are opening special access routes and leveraging the review of prior regulatory agencies.

• 2021-10-27 06:28:50

PFDA published the list of Value Added Tax (VAT) Exempted Medical Devices affected by the Corporate Recovery and Tax Incentives for Enterprises (CREATE) Act. CREATE Act affects tax and other financial implications for corporations most especially for pharmaceutical and medical device importers, manufacturers, and distributors.

• 2021-01-19 02:48:31

• 2020-02-12 14:09:42

China National Medical Product Administration (NMPA) has revised the special approval procedures for innovative medical devices issued in 2014 to respond to current state. This revision will be effective on December 1, 2018.

• 2020-02-14 04:20:17

China National Drug Administration (CNDA) has revised the special approval procedures for innovative medical devices issued in 2014 to respond to current state. Drafts of the revision were released in early May and is currently open for public comments. This revision will be expected to take effect on October 1, 2018.