Medtec China, the leading medical device design and manufacturing exhibition in China, will take place on 26-28 September 2018 in Shanghai. More than 400 exhibitors will showcase their latest offerings at Medtec China 2018, and more than 10,000 decision makers, purchasing staff, R&D engineers, product engineers and quality inspectors from medical device manufacturers will congregate […]
Medtec China 2018 Opens for Registration Read More »
ANVISA Changes for Low-risk Medical Devices 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
ANVISA Changes for Low-risk Medical Devices | Brazilian Registration Process Read 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 information Read More »
In the field of healthcare, assuring the safety and efficacy of medical devices is critical. Aside from functioning and durability, determining the possible emission of volatile organic compounds (VOCs) and particles from these devices is critical for patient safety and environmental compliance. This is where ISO 18562 comes into play. What is ISO 18562? ISO
Understanding ISO 18562: VOC and Particle Testing for Medical Devices Read 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 devices Read 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 2018 Read 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 Diagnostics Read 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 Government Read 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
Extension of CDSCO WHO’s GMP Certificate Read More »
When FDA added De Novo Pathway as an alternative pathway for medical device manufacturers seeking Class I or Class II classification of their novel products in 1997. Even though medical device products are automatically classified as a Class III device. The FDA’s initial De Novo process retained the application requirements whereby firms were first to submit a
Opportunity for Device Manufacturers on De Novo Pathway Extension Read More »
