By Ames Gross, President, Pacific Bridge Medical
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 year – and cancer causes more than 2.5 million deaths annually. According to the WHO, China accounts for half of global stomach, esophageal and liver cancer cases. And, these numbers are skyrocketing every year.
Q&A on Japan’s mixed medical treatment reforms
With Asia Medical Market Expert Ames Gross, Pacific Bridge Medical
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.
Asian regulatory update: China’s new five year plan shifts focus to domestic medical devices
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 domestic medical devices.
The health care reform for the domestic medical device industry provides unprecedented opportunities for Chinese biomedical development.
Asian regulatory update: Medical devices in Malaysia to register with Health Ministry
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 Devices Bill 2008 is presented to the Malaysian Parliament either at the end of March 2011 or in June 2011.
The new Medical Devices Act will require imported and local medical devices to be registered with the Health Ministry of Malaysia. This is to ensure quality products in medical treatments, as well as to legally protect the medical devices under the country’s patent law. Currently, registration of medical devices is not mandatory in Malaysia.
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 sector growth of 6 percent. APAC’s growth in medical devices will be driven by healthcare service providers’ demand for safe, reliable and cost-effective medical treatments, as well as consumers demanding better medical products.
The APAC medical devices market is estimated at $55 billion. This is about a quarter of the global medical devices market, valued at more than $230 billion. Medical devices manufacturers are expected to increase revenues in APAC from diseases related to diabetes, cardiovascular, orthopedic and infectious diseases.
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 affect medical devices in China. 34 of these new industry standards are mandatory (labeled YY) while the remaining 62 are recommended (labeled YY/T). The mandatory standards will be regulated beginning June 1, 2012.
Several of the mandatory industry standards are replacing other standards. For example, YY 0054-2010 for hemodialysis equipment will be replacing YY 0054-2003, and YY 0333-2010covering soft tissue dilation devices will replace YY 0333-2002. However, many others are new, such as YY 0804-2010 for medical fluid metastatis.
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 homecare and handheld devices sector will more than triple. Meanwhile, therapeutics, imaging devices and patient monitoring will account for the remainder of the estimated growth.
Currently, imaging is the largest sector followed by therapeutics, patient monitoring, and then homecare and handheld products. By 2015, homecare and handheld products will likely outstrip the patient monitoring sector.
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 1008 No. 1.
With this notification, marketing authorization holders (MAHs) who are involved in the foreign manufacturer accreditation (FMA) process must become more aware of the foreign manufacturer’s other MAHs and products. In the revised FMA application, the “Product and Process List” Form requires details on all of the foreign manufacturer’s products in Japan and the products’ corresponding MAH.
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 mandatory regulation of medical devices and in-vitro diagnostic medical devices. The new framework draws significantly from the Global Harmonization Task Force (GHTF) and the World Health Organization (WHO). Companies dealing with medical devices in Hong Kong should begin preparations for these upcoming regulations.