• 2021-11-24 10:36:48

2020 and 2021 had some regulations newly introduced by various ASEAN regulatory agencies. When these come into full implementation in 2022, stakeholders need to be well-equipped to face them and prepare a contingency plan to adopt them for the medical devices already in the market. In this article, we shall take a look at the regulations to be fully implemented starting 2022 in Malaysia, Singapore, Indonesia, Thailand, Vietnam and Philippines.

• 2021-08-02 06:26:52

On July 2nd, Qualtech had been invited to present and inform Japanese OMETA Members (Overseas Medical Equipment Technical Assistants) on the medical device regulation updates in Thailand, the Philippines, and Vietnam during the OMETA Online Seminar.

• 2021-06-29 11:23:58

On April 16th, Qualtech organized a webinar and guided participants through the Latest updates for medical device regulations in the Philippines, Thailand, and Malaysia. Our experts covered all the major topics and suggested details to pay attention to.

• 2021-03-29 01:45:09

Due to Qualtech’s vast experience in the ASEAN regulatory field, Qualtech’s specialists have been cordially invited to speak on the medical device registration processes in Vietnam, Indonesia, and the Philippines at the ASEAN Healthcare Market Conference.

• 2020-11-26 10:42:10

AI based SaMD is getting more traction in ASEAN counties, owing to their huge potential to transform healthcare industry. At the same time, local regulatory bodies are getting stricter in the evaluation of these AI based SaMD, for added safety and ensuring smooth performance. In this issue of QT Analysis, we are looking into the requirements for registering and marketing these AI based SaMD in selected ASEAN countries.

• 2020-10-28 02:13:28

With Overseas Medical Equipment Technical Assistants (OMETA), Qualteh has held an online seminar about regulatory updates in ASEAN on 27th October, where we covered major updates in the Philippines, Thailand, and Malaysia.

• 2020-05-06 09:31:48

PFDA在即將實施AO 2018-0002之前開始消除缺陷。 需要注意的是新的風險分類準則，翻新醫療設備的單獨範圍，準則和獲取本地醫療產品許可證的過程。