The US FDA released a statement on the topic of materials used in medical devices as part of their effort to address potential safety...

The exit of the United Kingdom (UK) from the European Union (EU) will cause implications to the medical industry in Australia....

The Association of Southeast Asian Nations (ASEAN) have published the following two documents under the section of Harmonisation of...

India's Ministry of Health and Family Welfare published a new gazette notification on 15 Jan 2019, regarding an amendment to the Medical...

Executive Summary: The latest Asian Medtech Associations Regulatory Networking discussions extended to news from Malaysia, Vietnam,...

Executive Summary: The January 2019 Asian Medtech Associations Regulatory Networking discussions focus on the volume of activity within...

The Info-communications Media Development Authority (IMDA) issued "Connected Medical Device Security" Technical Reference in end 2018....

Taiwan FDA is currently seeking public feedback on three new regulations in cosmetic products. The Authority proposing draft Regulations...

Both the Council Directive 93/42/EEC (MDD) and Council Directive 90/385/EEC (AIMDD) will transition into the Medical Device Regulations...

The IVDR is set to replace the IVDD in order to adapt to more technical/scientific requirements for IVDs to be placed in the EU...

With effective as of 2 January 2019, Medical Devices Authority will make the following changes: Malaysia MDA also recently introduced 2...

As of present, there are a total of 1,985 medical devices and 1,136 reagents registered. Currently in Cambodia, the AMDD is already...

MDA shed the light on the following statistics: Total establishment license: 2,300 Establishments; Manufacturers: 230 Authorized...

Myanmar releases updates on the various changes to their regulatory process in the most recent 7th AMDC Meeting. The Myanmar Department...

During the 7th AMDC Meeting, the medical device control division released updates on the pre-market and post-market control of medical...

In recent ASEAN meeting, Singapore HSA has reiterated the country's initiative to enhance the facilitation of immediate market access....

The AO 2018-002 provides guidelines governing the issuance of an authorization for a medical device based on the ASEAN Harmonized...

Current situation in Laos: 36 Companies involved in medical device market 1 medical device factory 98% of medical devices are imported...

Indonesia is attempting to simplify regulations by reducing the time needed for review, promoting easier access for license application...

The AMDTC is working on the following two key work items: Classification of products as Medical Device or Non-Medical Device in the...