This article was originally published on MedTech Intelligence. China has progressively been increasing its focus on medical innovation in recent years. China’s aging population and rise of chronic diseases make innovative medical technology crucial to delivering quality treatment to its population. Innovation... Read More
The Philippines, a Southeast Asian country made up of more than 7,000 islands, has a population of over 100 million people, making it the 12th most populous country in the world. The population grows by approximately 1.5 million people each year. The... Read More
Singapore’s main regulatory body, the Health Sciences Authority (HSA), announced the implementation of their ‘Class A Medical Device Register.’ This is a public database that enables people to search for importers/manufacturers and their respective imported/manufactured Class A medical devices that are exempt... Read More
Introduction In 2016, Malaysia’s economy expanded 5% and the population was at 30 million. The country also has the third highest GDP per capita adjusted for purchasing power pairty (PPP) in ASEAN at $27,000, behind only Singapore and Brunei (International Monetary Fund,... Read More
There are several steps to consider when entering the Asian medical device market. This presentation covers 10 essential steps to help grow your business in Asia. Case studies will be used to demonstrate key points. To view these presentation slides, please click... Read More
Recently, Prime Minister Narendra Modi’s Ministry of Health published a 108 page notification on medical devices in India. Significant changes to medical device regulations include: Device licenses will no longer expire. The manufacturer will need to pay a renewal fee every 5... Read More
In order to promote earlier market access of novel medical devices, Korea’s Ministry of Food and Drug Safety (MFDS) proposed changes for the “Regulation on Approval/Report/Review, Etc. of Medical Devices”. The proposed changes include: Designation criteria for rare-disease devices will include both... Read More
Local Chinese testing of medical devices is a key step in the approval process in China. The CFDA has charged thousands of dollars for mandatory in country testing of devices. Recently, the Chinese Food and Drug Administration (CFDA) has eliminated testing fees... Read More
This presentation provides an overview of the regulatory framework and drug registration process in India. To view these presentation slides, please click on Drug Registration in India Presentation. Table of Contents: Regulatory Framework in India FDC Registration Process in India... Read More
Over the last few years, 80% of the drug clinical trials in China have been withdrawn with their dossiers for product registration from the China Food and Drug Administration (CFDA). Drug companies are worried that fraudulent clinical trial data could get them... Read More