医疗设备的质量标准由of many aspects such as design control, risk management, vendor management etc. In this blog, we are going to discuss the importance of risk management ISO 14971 for medical devices and steps to implement it during the product development stage. ISO 14971 an international standard for risk management related …
Risk management system for medical devices | ISO 14971Read More »
The National Health Surveillance Agency or ANVISA (Agência Nacional de Vigilância Sanitária) is the Brazilian regulatory agency that is responsible for the approval and supervision of food, cosmetics, tobacco, pharmaceuticals, health services, and medical devices, among others. The agency is connected to the Ministry of Health, which manages ANVISA through a management contract signed periodically. Brazilian medical …
ANVISA Changes for Low-risk Medical Devices | Brazilian MarketRead More »
The Food and Drug Administration announced an additional “unique type of restriction” on the sale and distribution of an approved medical device. FDA issued an order requiring healthcare providers and facilities that offer the Essure permanent contraception device to provide specific information to patients about the risks and benefits of the device. This was not the first …
FDA announced on Approved Medical Device | FDA risk informationRead More »
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The regulatory approval process for medical devices is complex and not always well defined. The Food and Drug Administration (FDA) is the federal agency responsible for the regulatory oversight of medical devices in the U.S. Most medical device premarket reviews conducted …
ISO 18562 VOC and Particle Testing for Medical DevicesRead More »
President Donald Trump today directed his top trade negotiator to strongly take up with all countries the fixing of prices of American pharmaceuticals and medical devices. Describing such fixing of prices by other countries as unjustified and done at the expense of America’s research and development, Trump said that the US can longer tolerate such behaviour …
Trump directs USTR to take up pricing of pharmaceuticals, medical devicesRead More »
The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research Small Business and Industry Assistance (CDER SBIA), and Center for Devices and Radiological Health (CDRH) Division of Industry and Consumer Education (DICE) are pleased to announce a co-sponsored event developed just for you the Regulatory Education for Industry conference. The Regulatory Education for Industry (REdI) Conference is …
Regulatory Education for Industry (REdI) Spring Conference 2018Read More »
On Thursday, May 24, the FDA will host a webinar about two finalized guidance designed to enhance collaboration among researchers, and drive the efficient development of novel next-generation sequencing (NGS) based tests. Next-generation sequencing (NGS), massively parallel or deep sequencing are related terms that describe a DNA sequencing technology which has revolutionized genomic research. DNA sequencing is …
Final Guidances on Next Generation Sequencing | In Vitro DiagnosticsRead More »
The government has decided to tighten the reins on ultrasound machines and similar imaging equipment in order to prevent companies from importing these products into India without proper registration. The move is also expected to ensure that these products follow high-quality standards and are easier for the government to track in order to prevent abuse …
Regulation Of Imaging Equipment Strengthen By GovernmentRead More »
In a move to improve ease of doing business, India is increasing the validity of the World Health Organisation(WHO) Good Manufacturing Practices (GMP) certificate to three years. The CDSCO WHO GMP certificate was earlier valid for two years, said Drug Controller General of India Eswara Reddy during the 6th annual International Exhibition of Pharma and Healthcare (iPHEX) on Tuesday. The measure would also …
FDA has issued a draft guidance for Multiple Function Devices to clear up its policy for products that have more than one function. The draft, Multiple Function Device Products: Policy and Considerations; Draft Guidance for Industry and Food and Drug Administration Staff, is related to Digital Health and the 21st Century Cures Act. It suggests that …
FDA Releases Draft Guidance for Multiple Function DevicesRead More »