The Asian economy has experienced tremendous GDP growth over the past decade, and is expected to continue at a healthy pace for the next several years. In particular, the medical device market has been growing quite rapidly. More and more companies are... Read More
China’s State Administration of Radio, Film and Television (SARFT) and State Administration of Industry and Commerce (SAIC) passed regulations effective August 1, 2006, stating that any TV or radio commercials for medical products must state the names of the manufacturing and distributing... Read More
The Marketing Authorization Holder (MAH) system in Japan came into effect with the new Pharmaceutical Affairs Law (PAL) in April 2005. It was designed to set up a specific structure for companies handling the importation, market release, and postmarket surveillance of medical... Read More
On July 28, 2006, China’s Ministry of Health announced most individual hospitals would be banned from purchasing expensive medical equipment. For equipment costing over two million yuan (about US$250,000), public hospitals at the county level or higher and nonprofit medical institutions attached... Read More
On June 8th, 2006, the Japanese Diet passed an amendment to the Pharmaceutical Affairs Law concerning pharmacies sale of nonprescription OTC drugs. Prior to this amendment, the PAL rules on distribution had not been significantly amended since 1960, when the law was... Read More
A law that would allow the government to determine the prices of pharmaceuticals is close to being approved by the Philippine Congress, backed by consumer groups, health workers, clergy, and others. The Drug Prices Regulation Act of 2005 would create a board... Read More
The Chinese government has agreed to take action to eliminate redundancy in testing and certification for medical devices imported into China. China agreed that it would eliminate all duplicative testing and certification requirements for medical devices by the end of May 2006.... Read More
The Japanese government has announced that it plans to change the clinical trial requirements for new drug approval in Japan. In a March 2006 interview, Akira Miyajima, the Chief Executive of the Pharmaceutical and Medical Devices Agency (PMDA), stated that the PMDA... Read More
China’s State Food and Drug Administration (SFDA) recently issued a notice on new Drug Nomenclature Guidelines to begin standardizing drug names. In the past, many imitation drugs were registered under the unique brand or trade name, which created confusion in the marketplace.... Read More
The import and manufacture of medical devices in India is now regulated by guidelines issued by the Drug Controller General of India (DCGI). New medical device guidelines, which went into effect on March 1, 2006, outline the procedures and requirements for importing... Read More