In August 2011, the Thai FDA announced plans to amend the requirement regulating bioequivalence studies of new generic drugs. This change is made in an effort to expedite the drug approval process and provide more patients access to generic drugs in Thailand... Read More
Thailand is raising its quality control standards on local manufacturing of medical devices. According to Thai government officials, a medical device institute may be set up as a testing center for quality standards. New quality standards are also expected to be outlined... Read More
Introduction With the United States emerging very slowly from a huge recession, some of Europe unable to pay its bills, and more restrictions coming from the US Food and Drug Administration (FDA), an area where medical device companies may want to focus... Read More
Diabetes cases are dramatically on the rise in countries throughout Asia. The financially privileged city-dwellers tend to be the ones who have been identified as diabetics. Causes include insufficient exercise, high fat diets that have increasingly incorporated fast food items, genetics and... Read More
Medical Device Act B.E. 2551 was recently updated in October 2009 with new supplemental laws. These include Premises of Medical Device Manufacturing, Premise of Medical Device Importation, and The Rate of Medical Device Fees. Medical device manufacturers must describe their facility and... Read More
Asia is emerging from the global recession faster than other regions in the world. This article goes through some of the major regulatory updates in various Asian countries. Read More
On April 10, 2009, the Association of Southeast Asian Nations (ASEAN) Economic Ministers signed the ASEAN Sectoral Mutual Recognition Arrangement (MRA) for Good Manufacturing Practice (GMP). When implemented, GMP certification and inspection reports received in one ASEAN member nation (in accordance with... Read More
In February 2009, Thailand’s “Liability for Damages Arising from Unsafe Products Act” came into effect. Drug and device manufacturers selling products in Thailand will need to be aware of the changes in the legal system. Liability of unsafe products will change drastically... Read More
The Thai Food and Drug Administration (FDA) recently implemented a new phase of its Medical Device Act. This phase is the transfer of some regulatory powers to the provincial governments. Thailand’s new Medical Device Act went into effect in 2008, overhauling Thailand’s... Read More
Navigating global regulatory markets can be a challenge, particularly when multiple countries in a region differ in their rules. Playing by a common set of rules for medtech regulation is about to get a little easier in Southeast Asia, as a group... Read More