• 2020-03-18 10:32:08

The ASEAN Common Submission Dossier Template (CSDT) makes it significantly easier to penetrate the ASEAN markets collectively. Therefore, do not miss the chance to learn about the benefits of the CSDT and what documentations are required for developing the Common Submission Dossiers.

• 2020-02-21 07:28:02

Due to the novel coronavirus pneumonia epidemic and its impact on China, the NMPA, local testing center and clinical sites have been given priority to emergency medical device approvals in epidemic situations. As a result, the progress of ordinary cases may be delayed

• 2020-02-21 07:06:15

“Essential Regulatory Requirements for Medical Device Approval” Seminar by The Medical Products Consortium of Thailand: MPCT on 27-28 February 2020 is being hosted for the first time in Thailand aiming to promote research develop medical device innovation through the certification assessment process of The Food and Drug Administration Medicine accordingly to international guidelines.

• 2020-05-06 09:41:29

The OMETA Seminar is back in 2019, to give those interested the tools to evolve and accelerate their business.

• 2020-02-12 15:01:28

In order to effectively inform the stakeholders of these new regulations, HSA Medical Branch published the updated documents containing the overview of the whole Singapore regulation unto their website.

• 2020-02-13 06:14:29

Following the Executive Presentation on the New Fee Structure and Modernization Initiatives held last June 28-29, a draft of the New Schedule of fees has been posted which aims to notify all stakeholders concerning the significant increase in charges associated with medical registration,

• 2020-02-14 07:29:47

Medical Device Authority (MDA), Malaysia has recently introduced a new initiative calling for e-mail notification subscription by all interested stakeholders. This new initiative by MDA aims to provide the latest information to stakeholders and general public who wish to subscribe to this service,

• 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.

• 2020-02-15 06:27:24

 Starting in 2017, all medical devices imported into Vietnam will be required to register for Marketing Authorization (MA) licenses. The Ministry of Health began receiving registration dossiers on January 1, 2017, for medical devices categorized as Class A, and began receiving dossiers on July 1, 2017, for medical devices in Classes B, C, and D.

• 2020-02-15 06:40:47

he Philippine Food and Drug Administration (FDA) held its First Regulatory and Advocacy Fair last August 17 and 18, as part of the celebration of its 54th anniversary.