Earlier this year, India’s in vitro diagnostics (IVDs) rules of 2017 went into effect. IVDs are now classified in four classes: A, B, C, and D. The 2017 rules have a list of IVDs with their risk classification. More IVDs now require... Read More
In early September 2017, the China Food and Drug Administration (CFDA) released plans to implement a new Catalog of Medical Devices starting on August 1, 2018. The current classification directory was established in 2002 but has been under revision since July 2015... Read More
The Taiwan Food and Drug Administration (TFDA) has completed a draft of the new Medical Devices Act. The new act will effectively separate the management of medical devices from the existing Pharmaceutical Affairs Act. The draft proposal of the Medical Devices Act... Read More
Singapore’s Health Sciences Authority (HSA), which is administered by the Ministry of Health, plans to establish guidelines for telehealth devices. A telehealth device is any instrument, machine, or software that helps provide healthcare services through telecommunications. Under the proposed regulations, telehealth devices... Read More
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