The Vietnam medical device market is growing very quickly. To succeed there, foreign medical device companies need to understand the Vietnamese regulatory system and how to get product approval. Read More
The Korea Food and Drug Association (KFDA) recently revised the classification of six medicines. Two over-the-counter (OTC) drugs were re-categorized as prescription drugs, while two previously prescription drugs can now be sold at pharmacies OTC. Classifications of 11 other drugs... Read More
With a population of 1.2 billion, a growing middle class and a booming economy, India is experiencing increasing demand for medical devices. The Indian medical device market is thriving and currently has a total worth of about $3 billion (US), with growth... Read More
Singapore passed the Health Products Act in February 2007. This Act has been implemented in stages throughout the past few years. Under this Act, all Class A-D products require Singapore medical device registration with the Singapore HSA. Also, manufacturers, dealers, importers and... 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
The Health Products Act (HPA) regulates the manufacture, import, supply, and advertisement of health products in Singapore. Originally passed in November 2007, the HPA is being implemented in phases to minimize the impact on the medical device industry in Singapore. On May... Read More
The National Pharmaceutical Pricing Authority of India (NPPA) is attempting to crack down on pharmaceutical companies trying to escape governmental price regulations. Companies do so by shifting their products from the drug category to the dietary supplement segment. Experts state that this... Read More
Reintroduction of Medical Devices Regulation Bill (MDRB) In 2006, the MDRB was proposed by the Ministry of Science and Technology to consolidate laws related to medical devices and to establish the Medical Device Regulatory Authority of India (MDRA). This proposal was aimed... Read More
On June 16, 2011, the Chinese State Food and Drug Administration (SFDA) announced that the new interim “Provisions for Medical Device Recall” would go into effect on July 1, 2011. These interim provisions aim to gradually set up and improve the medical... Read More
China’s Ministry of Commerce (MOC) issued new guidelines on May 5, 2010 to improve the supply and distribution of pharmaceuticals over the next five years. These guidelines, the first of their kind issued by the Chinese government, stipulate goals of creating 1... Read More