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 22, 2013, The Philippines Food and Drug Administration (FDA) adopted a harmonized Post-Marketing Alert System (PMAS) for unsafe medical devices and other products within the scope of the FDA. Read More
The Philippines' market for pharmaceutical products is growing at its fastest pace in years, at about 13 percent annually. By 2014, experts predict that it will have a value of $4 billion. This would make the drug market in the Philippines almost... Read More
According to a recent report by IMS Research, Asia will soon lead the world in market revenue growth for diagnostic cardiology devices. From now through 2016, revenue from such devices in Asia is set to more than double. World demand will grow... Read More
Of the worlds 371 million people diagnosed with diabetes, nearly 200 million live in Asia. According to the International Diabetes Federation (IDF), those numbers are set to climb dramatically. By 2030, it is estimated that 522 million people worldwide will have diabetes,... Read More
Effective February 1, 2013, medical device and pharmaceutical manufacturers must now submit an electronic copy of the necessary forms in addition to a hard copy when applying for a License to Operate (LTO) and Certificate for Product Registration (CPR). Read More
The Filipino medical device market is worth more than $300 million, and it is set to grow at 9 percent over the next few years. Growth will be driven by increasing healthcare expenditures, medical tourism and a growing private sector. Demand will... Read More
The Food and Administration of the Philippines (PFDA) is undergoing radical restructuring to improve its services starting in 2013. As a result, the PFDA stopped receiving applications for the procedures listed below on December 1, 2012, and it is expected to resume... 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