New Common Technical Specifications (CTS) Annex II List A IVD devices have been published in the Official Journal of the European Union.The use of CTS is required by Article 5.3 of the IVD Directive (98/79/EC). IVD companies making these devices must review "new or revised regulatory requirement' as per clause 5.6.2 (h) of ISO13485.
International
03/16/2009
02/01/2009
In the huge expanse of Asia, Singapore and Hong Kong are small places. However, after Japan, they are among the most advanced medical markets in the region. These places also lead other nearby, much larger Asian markets: Singapore strongly influences the Association of Southeast Nations (ASEAN) and Hong Kong strongly influences China. While these two markets have had little medical device regulation in the past, they are both introducing new requirements.
01/30/2009
MPO
Navigating global regulatory markets can be a challenge, particularly when multiple countries in a region differ in their rules. Playing by a common set of rules for medtech regulation is about to get a little easier in Southeast Asia, as a group of countries prepares to unveil a more unified approach to oversight.
The Association of Southeast Asian Nations (ASEAN) is a political and economic grouping of ten countries making up all of Southeast Asia: Indonesia, Singapore,Malaysia, the...
11/18/2008
The Food and Drug Administration (FDA) opened its first international office in China in November. The opening of the office comes in light of increased scrutiny of the overseas inspection process conducted by the FDA. The China office is the first of several planned international offices to station permanent food, drug and device inspectors.
09/30/2008
Sept. 30, 2008 - Medical devices that are not approved in Australia may be used in patients with life-threatening illnesses provided the Therapeutic Goods Administration (TGA) is informed of the use within 28 days, according to a draft guideline. Australia’s Special Access Scheme considers the treating physician the approving authority for a device used with patients whose serious illnesses likely will result in death within months if early treatment is denied. The draft is...
03/20/2008
April 24 -25, 2008
Beijing, China
China is preparing to unveil new health-care reforms that could have a significant impact on the market in China for medical devices, healthcare services, and pharmaceuticals. In an effort to understand the direction of these reforms, and to maximize opportunities for U.S. suppliers, Under Secretary of Commerce Christopher A. Padilla will lead a Health-Care Policy Trade Mission to China, April 23-...
01/01/2008
Steve McRoberts, CSci CPhys MInstP
Global Principal Engineer - Medical, Underwriters Laboratories
EN ISO 14971:2007 is now harmonized to the European Medical Devices Directive (93/42/EEC), the Active Implantable Medical Device Directive (90/385/EEC) and In-Vitro Diagnostics Directive (98/79/EC). Until 31 March 2010 both the 2007 edition and the 2000 edition are harmonized providing a presumption of conformity to one or more essential...
01/01/2008
Medical Device & Diagnostic Industry
12/14/2007
Danny Chen, ChinaGate partnering with Underwriters Laboratories
December 14, 2007 -- SFDA published a notice on their website to request comments for draft guidelines regarding registration dossier basic requirement on the following 3 medical device categories:
1. Medical Device Containing Drug Ingredients
2. Medical Device Containing Animal Materials
3. Non-Electric Implant Medical Device
Compared with the...
