Medical Device Import License Articles & Analysis
17 news found
Obtaining the Marketing Authorisation Application (MAA) is a key step in the commercialization of drugs in the EU, and also an important help to promote the global market expansion of pharmaceutical companies. ...
The EU Active Substance Master File (ASMF) is a technical document containing confidential information on an API that is submitted by the manufacturer of the API to the EMA or the medicines regulatory authority of an EU member state. As a form of DMF in the EU, the ASMF is used to support MAA or MAV by manufacturers of pharmaceutical preparations for human or veterinary use. The ASMF applies to ...
U.S. medical device regulations require manufacturers of most class II and a small number of class I devices to file a 510(k) unless they qualify for an exemption. 510(k) is a premarket technical document submitted by the manufacturer to the FDA before the medical device product enters the US market to prove that ...
Agent Proregulations submits ANDAs to the FDA for foreign applicants and communicates any FDA notices, warning letters or other important information in a timely manner. About Proregulations As a leading provider of product consulting and regulatory compliance solutions, Proregulations is committed to providing efficient and customized solutions to various industries around the ...
The FDA regulates cosmetics and their ingredients on the U.S. cosmetics market. Strict adherence to FDA regulations and standards is essential for the smooth entry and successful operation of cosmetic products on the US market. At Proregulations, a company that specializes in assisting with regulatory compliance, we offer U.S. Cosmetics Registration services designed to ensure that cosmetics meet ...
Thus, the production and filing of DMFs has become an important aspect of regulatory compliance for pharmaceutical companies. ...
SANUWAVE Health, Inc. (OTCQB:SNWV), a leading provider of next-generation advanced wound care medical systems for the repair and regeneration of skin and vascular structures and the research for new applications for shockwave systems in the non-medical field, announced today the patent activity for the full year 2020 and the first quarter of ...
Spectrum Dynamics Medical, Inc., has received Canadian Medical Device License from Health Canada for its premium digital SPECT/ 64-sliceCT scanner, VERITON-CT64. VERITON-CT64 is designed for both, total body and organ-focused, hybrid imaging with shorter scan times, at lower injected activity when compared to current analog dual-detector technology. VERITON-CT64 SPECT/CT digital technology plus ...
Hyperfine, Inc. (Nasdaq:HYPR), creator of Swoop®, the first FDA-cleared portable magnetic resonance imaging (MRI) system™, is proud to announce that Queen’s University and Kingston Health Sciences Centre are deploying a Swoop system as part of their health services benefitting six communities located in the James Bay and Hudson Bay Area. Until now, patients needing routine or ...
FUJIFILM VisualSonics, a global provider of ultra-high-frequency (UHF) ultrasound imaging systems, and PIUR IMAGING, the European leader in tomographic ultrasound imaging, have partnered to bring UHF, three-dimensional (3D) ultrasound imaging technology to clinicians and researchers. This technological advancement supports clinical research in the evaluation of anomalies in several applications, ...
These studies were the basis of a Health Canada Medical Device License for aerSleep® I and the designation of the second generation aerSleep® II as a Breakthrough Device by FDA. More information about the SUPRA trial may be found at clinicaltrials.gov. “SUPRA is an important study for both patients ...
“Despite the global pandemic, the past year has shown unprecedented growth and academic interest in micro-ultrasound with many important new publications in well-respected, high-impact journals,” says Dr. ...
TORONTO, CANADA -- (March 23, 2021) Exact Imaging (www.exactimaging.com), the world’s leader in high resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance for the prostate, announces $5.1M in financing provided by BDC Capital, through the Bridge Financing Program, and Export Development Canada (EDC). “We are thrilled to have BDC Capital and EDC as new ...
The world has been and continues to unite to “flatten the curve” of the outbreak of COVID-19. Exact Imaging began its support of this critical initiative on Friday March 13, 2020. We have implemented the following measures to ensure we protect and support our customers, employees, suppliers, and business: Observe Self-Isolation Guidelines – All Exact Imaging employees ...
SEATTLE, May 26, 2020 /PRNewswire/ — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced today it received CE mark certification for the 14-Day version of the Carnation Ambulatory Monitor (“CAM”) patch, the industry’s only P-wave centric ambulatory cardiac patch monitor and ...
Biomatlante, a world leader in synthetic bone regeneration technologies, is pleased to announce the obtention of the MDSAP* accreditation on the new ISO 13485:2016 Certificate. The Medical Device Single Audit Program (MDSAP) is an international program for assessing the quality management systems of medical device manufacturers who market their products in Australia, Brazil, Canada, Japan and/or ...
Proa Medical, Inc. was granted a Device Manufacturing License by the Department of Public Health Food and Drug Branch of the State of California. "Proa Medical has a high commitment to quality and has created a culture of quality that reaches all aspects of its operations," said Proa Chief Operating Officer Afshin Nadershahi. ...