In July, India’s Ministry of Health and Family Welfare formally launched the Materiovigilance Program of India (MvPI). This plan will monitor the quality of medical devices in India and seek to improve patient health and safety. According to the Indian Pharmacopoeia Commission,... Read More
The China Food and Drug Administration (CFDA) issued more comprehensive guidelines for manufacturing three types of medical devices: sterile and implantable devices, and in-vitro diagnosis reagents. The guidelines for medical device manufacturing in China come into effect on October 1, 2015. The... Read More
The Drug Controller General of India (DCGI) has initiated strategies to strengthen regulatory oversight of India’s pharmaceutical industry. India expects to add about 200 more drug inspectors in the coming months to build up their drug regulatory capacity. Previously, oversight of India’s... Read More
In early July, the Chinese Food and Drug Administration (CFDA) announced that they will begin to conduct regular surprise inspections of pharmaceutical and medical device manufacturers starting on September 1, 2015. In addition to the regular inspections, a manufacturer may also be... Read More
台湾食品和药物管理局（TFDA）日前宣布，计划从2015年7月1日起修改医疗器械上市许可 审批制度。申请人需要提交质量体系文件（QSD）核准通知书作为初始上市许可申请文件的一 部分。目前，TFDA有时允许申请人初次申请文件提交后几个月后提交这些QSD信件。 行政文件的初步审查后，TFDA将对高风险的医疗器械的临床前试验文件和出厂质量控制文件进行评估。安全性、质量和性能将会被特别审查。注册申请费也将上调。 Read More
The Taiwan Food and Drug Administration (TFDA) recently announced plans to change the country’s medical device marketing authorization approval system starting July 1, 2015. Applicants will need to submit Quality System Documentation (QSD) Approval letters as part of the initial marketing authorization... Read More
China Releases Device Quality System Regulations Read More
中国颁布新的医疗器械质量管理法规 Read More
On March 24, 2014, the China Food and Drug Administration (CFDA) announced a 5 month national campaign to reinforce medical device product standards. The campaign will focus on the manufacture, sale and usage of Class 2 and Class 3 devices. Growing at... Read More