• 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.

• 2021-11-24 09:58:33

In an effort to combat the proliferation of unregistered/unnotified medical device products in various establishments and platforms, PFDA released the guidelines on the licensing of retailers of medical devices in the Philippines.

• 2021-11-24 08:44:32

With the implementation of Risk Classification under the new regulation, Thai FDA agreed to make an amendment to the evaluation expenses. The evaluation fee shall follow the new rates unless the applicant is eligible for a waiver or exemption.

• 2021-11-24 03:19:40

A golden opportunity has opened for manufacturers or importers to shorten the duration of Medical Device Registration of those under Class4 with Thailand FDA and HSA Singapore Regulatory Reliance.

• 2021-11-24 03:09:42

MOH has recently released new Decree that is intended to unify all regulations on Medical Device Management and implemented from next year.

• 2021-10-27 07:52:46

Every once in a while, Japanese Ministry of Health, Labor and Welfare (MHLW) issues notices to announce evaluation principles of “Next-Generation Medical Devices,” to accelerate review and approval process of new medical devices which has high demands and high feasibility of product realization. Since 2008, there have been 27 issuances by MHLW listed in the end of this article.

• 2021-10-27 07:25:14

Recently, MOH has introduced regulations for a total of seventeen COVID-19-related medical device categories, along with their submission dossiers and routes. Specifically, there are seven selective cases that can applied for fast approval. This circular also includes regulation on Import of medical device in view of COVID-19 prevention for purposes of aid.

• 2021-10-27 06:53:26

HSA communicated to the public regarding a cybersecurity vulnerability named "BrakTooth". It affects various IOT devices, which includes medical devices that use specific Bluetooth Link Manager Protocols. HSA shared steps to shareholders to avoid or address issues pertaining to BrakTooth.

• 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.

• 2021-10-27 05:47:59

To protect human health and the environment from Persistent Organic Pollutants (POPs), Thai FDA agreed to abide by the Stockholm Convention. In order to establish control measures, they conducted a survey of products/manufacturing processes that utilize perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds, and benzyl cyanide.