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Asian regulatory update

New Medical Device Management Center in China China’s State Food & Drug Administration (SFDA) officially inaugurated its Management Center for Medical Device Standards March 30. The inauguration...

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Asian regulatory update: Indian medical device manufacturers push for changes

Indian medical device manufacturers push for changes A group of Indian medical device manufacturers is lobbying for changes in the current duty structure on medical devices, currency stability, cheaper...

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Asian regulatory update: Japan, Singapore to exchange regulatory information

Medical regulatory information to be exchanged between Japan and Singapore The Health Sciences Authority (HSA) of Singapore and the Pharmaceutical and Food Safety Bureau of the Ministry of Health,...

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Asian regulatory update: China’s SFDA chief dismissed

China’s SFDA chief dismissed The deputy chief of China’s State Food and Drug Administration (SFDA), Zhang Jingli, has been removed from his post and is being investigated by an anti-corruption body,...

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Asian regulatory update: Singapore’s HSA updates medical device Technical...

Singapore’s HSA updates medical device Technical Specification Singapore’s Health Sciences Authority (HSA) included secondary assembly activity guidelines in its medical device Technical Specification...

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Asian regulatory update: Hong Kong’s hospitals to purchase new medical equipment

Hong Kong’s hospitals to purchase new medical equipment Recent investigations found that many of the more sophisticated medical devices that are generally available in more developed countries are...

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Asian regulatory update

Hong Kong’s government currently does not strictly regulate most medical devices. However, in late August 2010, Hong Kong’s Medical Device Control Office proposed a framework for comprehensive and...

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Asian regulatory update: Japan changes foreign manufacturers accreditation

Japan Issues Minor Changes to FMA Application On October 8, 2010, the Pharmaceuticals and Medical Device Agency (PMDA) of Japan’s Ministry of Health, Labour and Welfare (MHLW) released Notification...

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Asian regulatory update: India’s medical device market to grow 17% by 2015

India’s medical device market will experience a compound annual growth rate of 17 percent over the next five years. The market will expand by 150 percent in 2015, reaching a value of $2 billion. The...

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Asian regulatory update: New industry standards for medical devices in China

New industry standards for medical devices in China On Dec. 27, 2010, China’s State Food & Drug Administration (SFDA) website was updated with an announcement on 96 new industry standards that will...

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Asian regulatory update: Asia-Pacific medical device market gets healthier

Asia-Pacific medical device market gets healthier The Asia Pacific (APAC) medical devices market will grow more than 10 percent over the next three years. This is higher than the projected global...

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Asian regulatory update: Medical devices in Malaysia to register with Health...

Medical devices in Malaysia to register with Health Ministry Malaysia will soon introduce its Medical Devices Act by the end of 2011. This Act is expected to be established when the current Medical...

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Asian regulatory update: China’s new five year plan shifts focus to domestic...

China’s 12th Five-Year Plan outlines three initiatives with respect to medical devices: 1. Increase the development of China-made medical equipment. 2. Implement centralized procurement 3. Purchase...

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China Simplifies Medical Device Re-registration in 2014

By Ames Gross, Pacific Bridge Medical On December 17, 2013, the China Food and Drug Administration (CFDA) announced a streamlined device registration renewal process that took effect on January 1....

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Q&A on Japan’s mixed medical treatment reforms

With Asia Medical Market Expert Ames Gross, Pacific Bridge Medical Q:  What is a mixed medical treatment? A:  A mixed medical treatment combines 2 treatments. One of the treatments is a pharmaceutical...

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Q&A on the Chinese cancer market

With Asia Medical Market Expert Ames Gross, Pacific Bridge Medical Q1. Is cancer a big issue in China? A. Cancer is the #1 cause of death in China. More than 3.5 million Chinese develop cancer every...

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Japanese elder care market: 4 key medical device segments

By Ames Gross, President, Pacific Bridge Medical There are 30 million Japanese over the age of 65, accounting for almost 25% of the Japanese population. Japan also has a purchasing power parity GDP...

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