The Ministry of Public Health in Thailand announced in late 2002 that it is drafting a new Medical Device Act. The new act will include revised registration requirements as well as regulations on product liability. The act will also outline the licensing... Read More
This article covers some of the changing dynamics of the regulatory scene in Asia for pharmaceuticals and medical devices, with information and updates from China, Korea, Japan and Taiwan. Drug prices and reimbursement rates have been cut as governments take steps to... Read More
In January 2003, the Shanghai Drug Administration Bureau announced its resolve to tighten controls over pharmaceuticals and drug distribution as well as create more efficient systems for reporting adverse reactions to medication. According to recent reports by the bureau, of 14,980 drugs... Read More
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