For more information about Chinese regulatory agencies and China device registration, please see Medical Device Registration in China. You are welcome to use or share this infographic online or in your presentations and papers, as long as you include credits to Pacific... Read More
Finding the right Chinese medical executives can be a challenging proposition. Certain positions, like regulatory executives, general managers, and excellent business development executives are currently in short supply. Over the last five years, the salaries of Chinese medical executives have also skyrocketed.... Read More
Finding the right medical executives for your Japan office can be challenging. If you headhunt a Japanese medical executive and the executive turns out to be not as good as you thought, this could lead to problems in your Japan business. For... Read More
The process of hiring qualified medical executives for your India office can be difficult. Due to Indias fast growth recently, there is increased competition to find the top medical talent to staff medical companies in India. There is a very strong demand... Read More
As PBM noted in a July news brief, Chinas revised Regulations on the Supervision and Administration of Medical Devices went into force on June 1, 2014. On August 1, the China Food and Drug Administration (CFDA) released additional detailed information on implementing... Read More
On August 1, 2014, the U.S. Food and Drug Administration (FDA) announced the fiscal year 2015 user fees for pharmaceutical and medical device companies. These rates will be effective from October 1, 2014 through September 30, 2015. For medical devices, a premarket... Read More
In late June 2014, the Japanese Cabinet approved Prime Minister Shinzo Abes new economic growth strategy. One of the proposed reforms is to deregulate some of Japans highly protected industries -- including healthcare. A key pillar of Abes economic strategy is expanding... Read More
PBM在七月简讯报道，中国修订了医疗器械的监督管理条例并于6月1日开始生效。2014年8月1日，中国食品药品监督管理局（CFDA）公布法规修订后的实施细则。这些实施细则将于2014年10月1日开始生效。 Read More
2014年8月1日，美国食品和药物管理局（FDA）宣布2015年的制药和医疗设备申请费。 这些费率将在2014年10月1日至2015年9月30日有效。对于医疗器械，上市前申请（PMA）将耗资250，895美元；510（K）上市前通知将提高到5018美元。 Read More
The past several months have seen several announcements by the Malaysian Medical Device Authority (MDA). First launched in mid-2013, the online Medical Device Centralized Application System (MEDCAST) was expanded to support in vitro diagnostic (IVD) device submissions in May 2014. The MDA... Read More