SPRING Singapore (Standards, Productivity and Innovation Board) and the Economic Development board launched Singapore’s first efforts to standardize the country’s medical devices industry on January 17, 2003. The standard proposed by the governing authorities is called the Technical Reference for Medical Device... Read More
The Japanese Ministry of Health, Labor and Welfare (MHLW) recently announced the establishment of a new Good Laboratory Practice (GLP) regulation for medical device testing in Japan. The new GLP will take effect on October 1, 2003 and will regulate pre-clinical trial... Read More
Certification is often required in many countries for designated products such as electronics and medical devices. Regulated products cannot be sold without certification marks if they have been designated as “compulsory certification products.” Product certification marks are used to inform consumers of... Read More
Informed consent is a concept that requires physicians to share decision-making power regarding medical treatment with their patients. This concept originated in the U.S. and there is no history of informed consent in Japan. Thus, the vast majority of Japanese are not... Read More
Authorities at the State Drug Administration (SDA) in China announced earlier this year that they are planning to implement nine new complementary regulations and methods for drug product registration in the country. These new regulations will be implemented from the end of... Read More
In Japan, it is still common for medical doctors to limit the amount of information they give to their patients. Doctors in Japan are seen as “kings,” similar to the situation in the U.S. in the 1950s and 1960s prior to managed... Read More
The main regulatory body in charge of overseeing medical devices in South Korea is the Korea Food & Drug Administration (KFDA) established in 1996. Through the Medical Devices & Radiation Health Department, the KFDA performs inspections and quality assurance as well as... Read More
The Singaporean Ministry of Health (MOH) announced on August 20, 2002, that they are implementing new regulatory controls over Chinese proprietary medicines (CPMs). Due to the rise of recent health related problems as a result of CPM consumption, the Ministry is tightening... Read More
The China Compulsory Certification (CCC) mark has replaced the old China Commission for Conformity Certification of Electrical Equipment (CCEE) and China Commodity Inspection Bureau (CCIB) marks as of on May 1, 2002. The CCC will replace the previous certification systems as the... Read More
Since 1985, Japan’s In Country Caretaker (ICC) system has allowed foreign medical manufacturers without a local office in Japan to register products “directly” in their own name (Japan law does not allow medical companies without a local presence to register their products... Read More