Nearly ten percent of India's 1.24 billion people suffer from chronic kidney disease (CKD), a disease in which the kidney slowly loses function and fails. One 2013 survey found that more than 15 percent of urban Indians have the disease, with rates... Read More
China’s Food and Drug Administration (CFDA) has proposed exempting 25 categories of Class II medical devices from clinical trials. Altogether, there are 142 devices on the draft list, including: Single-use, sterile tissue clamps Blood and infusion warmers Medical gas alarm systems Portable... Read More
The largest ever study of kidney disease in India has found that 17 percent of urban Indian residents have chronic kidney disease (CKD). Rates are as high as 47 percent in some cities. Most of the Indians surveyed were unaware they had... Read More
Demand for orthopedic devices is surging across Asia, as people there become older and wealthier. Sales of knee implants, hip implants, trauma devices and other orthopedic products have experienced double digit growth since the early 2000s. However, although half of the world's... Read More
The government aims to promote and support growth and innovation in Chinas medical device industry. To this aim, the CFDA has released a draft of a new process to increase the efficiency of the review and approval process for innovative medical devices. Read More
Currently, medical device companies must re-register within six months of the expiration of the original products registration certificate. Re-registration requires submitting substantial documentation, much of which is duplicate documentation from the original 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
Previously, China was associated primarily with low tech components and disposable medical devices. But over the last five years, Chinese manufacturers have made considerable strides in both medical technology and product quality. High end products like diagnostic imaging technology can now be... Read More
The medical device market in Korea is growing quickly, at an annual average rate of 13.5 percent. It had a value of $3.9 billion in 2012, making it the third largest medical device market in Asia. Korea's medical device market is expected... Read More