Thailand: Approval Of Public Sale Of Home HIV Test Kits Via Pharmacies

The Thai FDA and Department of Disease Control and the Thai Red Cross AIDS Research Centre have approved the public sale of home HIV test kits via pharmacies.

Thailand has one of the highest HIV prevalences in Asia and the Pacific, accounting for 9% of the region’s total population of people living with HIV; however, it was the first country to effectively eliminate mother to child transmissions, with a transmission rate of less than 2%. (more…)

2019-05-02T10:54:03+08:00 May 2nd, 2019|Insight, News & Events|

The Philippines: 2019 FDA Academy Training and Seminar Schedule

FDA Academy

The Food and Drug Administration in the Philippines established the FDA Academy to provide access to relevant and effective training as part of its continuous service to stakeholders and industries. The conduct of such training ensures correct dissemination of policies, procedures, and guidelines implemented by the FDA.

The FDA Academy training sessions are designed to ensure that industry representatives nominated by regulated establishments have a thorough understanding of the FDA policies and regulations and the necessary knowledge to enable them to correctly prepare and submit registration applications. (more…)

2019-05-02T09:29:18+08:00 May 2nd, 2019|Insight, Medical Regulation Updates, News & Events|

Thailand: MDA 2019 – The International Exhibition and Conference on Medical Device Technologies, Service Solutions and General Healthcare

MDA 2019

Medical Devices ASEAN 2019 (MDA 2019) positions Thailand as a hub for medical devices and the focal point for medical academics in the ASEAN region.

MDA 2019, an international exhibition and conference on medical device technologies, service solutions and general healthcare, serves as a key meeting place for medical device and healthcare professionals to gain the latest updates, techniques, and knowledge, to network and do business.

(more…)

2019-05-02T09:56:59+08:00 May 2nd, 2019|Event, News & Events|

Malaysia: Notification on Medical Devices for Special Access

special access

On 8th April 2019, the Medical Device Authority (MDA) in Malaysia released a first edition guidance document, “Notification on Medical Devices for Special Access”.

Under the Medical Device (Exemption) Order 2016, medical devices for special access are exempt from registration with the MDA. Medical devices that meet the following criteria are eligible for special access status and can apply via the Notification route:

(more…)

2019-05-02T05:30:57+08:00 May 2nd, 2019|Medical Regulation Updates, News & Events|