Registering a medical product in Japan, from initial application to final approval, is known to be a very lengthy process, and could potentially become even more drawn out due to growing conflict over personnel issues at the PMDA. Many argue that one... Read More
The Hong Kong Medical Device Control Office (MDCO) is planning to introduce a conformity assessment (CA) framework as part of its its Medical Device Administrative Control System (MDACS). The framework is intended to improve the quality management of medical devices. The CA... Read More
In recent years, cancer has become a more salient issue in China. Currently, 1.5 million Chinese die of cancer annually, more than any other disease, and this number is growing fast. Chinese make up one quarter of all cancer sufferers in the... Read More
As a number of Singapore-based companies move into medical device production, government agencies are identifying the sector as a key growth area. Products which local companies have moved into recently include airway devices, infusion pumps, and gas detection equipment. These companies are... Read More
On March 1, 2006, a set of guidelines on the import and manufacture of medical devices, issued by the Drug Controller General of India (DCGI), became effective in India. (Subsequently, the effective date was postponed to June 30, 2006) Ten common sterile... Read More
As part of a new pharmaceutical policy proposed by the Indian government, medical device manufacturers could face new price restrictions when selling to public-sector medical institutions. In the new policy, high-price, critical medical devices would come under a differential pricing system, to... Read More
The U.S. International Trade Commission will be conducting a fact-finding investigation into the competitive conditions in Japan and other foreign markets for medical devices and equipment. The investigation will focus on comparing the regulatory environment in Japan with those of other countries... 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
Asia has a population of over 4 billion people, and represents about 60% of the world's population. Annual economic growth rates in the Asian countries have been as high as 8 or 10% over the past decade, in comparison with some developed... Read More
At a national conference in April 2006, the SFDA announced the launch of a new anti-corruption campaign targeted at drug and device manufacturers and distributors in order to crack down on commercial bribery. The main objective of the campaign is to provide... Read More