ASEAN Medical Device Regulatory Update
The forthcoming ASEAN Medical Device Directive (AMDD) will cover harmonization for a Common Submission Dossier Template (CSDT) and will govern requirements of product registration. Read More
The forthcoming ASEAN Medical Device Directive (AMDD) will cover harmonization for a Common Submission Dossier Template (CSDT) and will govern requirements of product registration. Read More
On April 19, 2013, a special committee, chaired by the Industry Ministry’s permanent secretary Mr. Vitoon Simachokdee, approved the plan for a medical industrial park in Thailand. The allotted zone will be divided into 500 rai (200 acre plots). It will include... Read More
With more than 600 billion people and a combined GDP of $2.3 trillion, the ten nations that make up the Association of Southeast Asian Nations (ASEAN) are already experiencing dramatic economic growth. This is especially true of the medical device market, which... Read More
Thailand's medical device market was worth more than $850 million in 2012 and is set to expand at 7.5 percent annually over the next several years. The medical device market in Thailand continues to boast strong economic growth, even in the face... Read More
ASEAN (Association of Southeast Asian Nations) recently released a draft of the ASEAN Medical Device Directive (AMDD) for comments in August 2012. This draft aims to enhance and harmonize medical device regulations among member countries. ASEAN plans to implement the Directive by... Read More
The Association of Southeast Asian Nations (ASEAN) is set to introduce the ASEAN Medical Devices Directive (AMDD), a uniform set of regulations that will cover all 10 of its member states. The AMDD will be written based on the Global Harmonization Task... Read More
Although still heavily reliant on drug imports, Thailand's domestic pharmaceutical market is steadily growing. The Thai pharmaceutical market is currently valued at about $4.3 billion. The Thai generic sector is expanding as the government is encouraging the use of generic drugs over... Read More
The number of cancer cases is dramatically increasing in countries throughout Asia. Asia now accounts for about 50% of all new cancer cases in the world, or about 6 million new cancer cases annually. The most common cancers in Asia are: lung,... Read More
The Thailand medical device market is current valued at $800 million and is quickly growing. It is expected to expand at about 8% annually over the next 5 years. Meanwhile, the Thai government continues to support a universal healthcare system. Since April... Read More
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