Clinical Operations-Design to Execution

BayBiotech.NET At present, the Indian market for medical devices is largely unregulated and Medical devices can freely be imported into India. Solely, the key decision maker is either the doctor, or a private or government hospital that evaluates the device and imports it to India. Although the FDA approved products are preferred because of their better quality and performance, but since India is a price sensitive market, low priced, poor quality medical devices find a bigger and more favored market. To ensure the quality of healthcare service and keeping the globalization of the clinical trials in mind, the Government of India is in the process of developing regulations for medical devices. A set of guidelines are expected to evolve that would bring a select group of medical devices under the regulatory framework. In India, the authority regulating medical devices will be the Central Drug Standard Control Organization (CDSCO) in the Ministry of Health. The CDSCO is the author...

BayBiotech.NET RoHS (Restriction of the Use of Certain Hazardous Substances) directive bans placing the new electrical and electronic equipments on the EU market containing more than agreed levels of lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyl (PBB) and polybrominated diphenyl ether (PBDE) flame retardants. These are the regulations under EU Directive 2002/95. The RoHS Directive and the UK RoHS regulations came into force on 1 July 2006. Since then, there have been amendments about exemptions regarding the levels of abovementioned articles in certain products. In order to get the latest on the exemptions as well as to understand the directive before manufacturing your product for the European market, follow the link: http://www.rohs.gov.uk/Default.aspx.