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美国食品药品监督管理局（U.S. Food and Drug Administration；FDA）发布了几份重要文件。2014年9月16日，FDA发布了关于新药简略申请（abbreviated new drug application；ANDA）的指导原则的最终稿，此文件解释了有可能导致FDA拒绝接收某一个ANDA的几种具体申请缺陷。FDA也发布了一份指导文件草案,概述了各种由于杂质限度确定不恰当而导致ANDA申请不被批准的原因。 Read More

There are many new changes in the Japanese medical device regulations. Read More

In late September 2014, the Indian Health Ministry released several amendments to the country’s Drugs and Cosmetics Rules, effective immediately. Medical devices must now be labeled with information such as the device name, batch number, expiration date, manufacturing license number and address... Read More

In August 2014, the Association of Southeast Asian Nations (ASEAN) -- which includes Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand and Vietnam -- signed the ASEAN Medical Device Directive (AMDD). The AMDD creates a harmonized regulatory model for ASEAN... Read More

India is one of the fastest growing medical device markets in the world. This presentation offers an overview of important issues such as distributor search in India, medical device regulations, registration requirements, intellectual property, and more.   To view these presentation slides,... Read More

China: Medical Device/In Vitro Diagnostic Clinical Trials Update On July 30, 2014, the China Food and Drug Administration (CFDA) released detailed information on implementing the revised Regulations on the Supervision and Administration of Medical Devices.  Order No. 4 covers Administrative Measures for... Read More

Medical devices in India are regulated under the Drugs and Cosmetics Act, which focuses on drugs and not devices. As of now, there are no separate medical device regulations, although a new medical device bill has been pending in India for over... Read More

The Thai Food and Drug Administration (FDA) recently announced an electronic common technical document (eCTD) pilot program for drug application dossiers. The pilot program will start in October 2014. After feedback from the pilot, the Thai FDAs electronic submission system will be... Read More

The U.S. Food and Drug Administration (FDA) has several pilot programs underway that should make many medical device applications simpler and faster. For premarket notifications, the 510(k) eSubmissions Program will guide companies in putting together and submitting a 510(k) application -- resulting... Read More

2014年7月30日，国家食品药品监督管理总局（CFDA）颁布了新修订的医疗器械监督管理条例的实施细则。其中包括局令第4号医疗器械注册管理办法和局令第5号诊断试剂注册管理办法。这些实施细则也涵盖了有关临床试验的最新要求，这些新规定将于2014年10月1日起执行。 Read More