Malaysia Medical Device Authority product classification steps (click to download full size image). Read more about why it is important to classify your product before registering your product as a device in Malaysia. For more information about our medical device or pharmaceutical registration... Read More
The Indian drug price regulator, the National Pharmaceutical Pricing Authority (NPPA) proposed in January 2017 to categorize stents into two categories: drug-eluting stents (DES) and bare-metal stents (BMS). Along with this proposal, the NPPA also proposed to fix the prices of these... Read More
Late last year, the US and China held their 27th annual Joint Commission on Commerce and Trade (JCCT) meetings in Washington, DC. The US and China are the world’s two largest economies and are key trading partners. China has the second largest... Read More
On September 30, 2016, the China Food and Drug Administration (CFDA) published an update to “Exemption list of Class II and Class III devices for local clinical study”. Following the May 2016 release of the original list, there are now a total... Read More
This article was also published on MedTech Intelligence. The Association of Southeast Asian Nations (ASEAN) is an international organization made up of 10 countries in Southeast Asia, including Indonesia, Singapore, Thailand, Malaysia, Vietnam, the Philippines, Brunei, Laos, Cambodia and Vietnam. ASEAN has a... Read More
Japan has become the second largest market for in vitro diagnostics (IVD) in the world. In Japan, the Ministry of Health, Labor, and Welfare (MHLW) and the Pharmaceutical Medical Devices Agency (PMDA) are the two main regulatory authorities that manage pharmaceuticals, medical... Read More
Singapore’s Health Sciences Authority (HSA) is finalizing guidance on medical devices classification for registration purposes. In July, the HSA issued two documents: GN-12-1: Guidance on Grouping of Medical Devices for Product Registration – General Grouping Criteria; and GN-12-2: Guidance on Grouping of Medical... Read More
中国颁布新的医疗器械注册申请收费草案 Read More
This presentation provides an overview of the Asian medical device markets and covers important regulatory issues for specific Asian countries, including China, Japan, India, Thailand, and Vietnam. To view these presentation slides, please click on Asia Medical Device Markets Overview Presentation ... Read More
China's medical device and IVD market has grown to over $20 billion, the third largest in the world. The number of foreign medical device manufacturers registering their products in China has grown exponentially. To be successful in this fast growing market, view... Read More