Clearing Regulatory Hurdles with a 510K Premarket Notification
Submitting a 510 K Premarket Notification is an essential step in the process of getting medical devices approved by
... Read moreSubmitting a 510 K Premarket Notification is an essential step in the process of getting medical devices approved by
... Read moreIntroduction: Medical devices are an important part of healthcare and play a critical role in the treatment of patients.
... Read moreHow Medical Devices are Classified in Canada Regulatory Classification Basics for your Medical Device: There are certain rules that apply
... Read moreThe Medical Device License is a legal document required to manufacture, sell, and distribute medical devices. The Medical Device
... Read moreThe FDA or U.S. Food and Drug Administration recently announced the Fiscal Year Medical Device User Fee (MDUFA) amendments. The
... Read moreThe Medical Device License is a legal document that is required for the manufacture, sale, and distribution of medical devices.
... Read moreNowadays almost all the facets of healthcare are well-equipped with the modern and latest technology tools, including software systems. The
... Read moreQuality Smart Solutions offers the best FDA Facility Renewal & Registration services in North America for Medical Devices, Food, and
... Read moreIn response to the COVID-19 public health emergency, FDA issued a declaration regarding the appropriateness of utilizing emergency use authorizations
... Read moreOn December 11, 2021, Health Canada issued a notice regarding the annual adjustment of fees for drugs and medical devices
... Read moreInterim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (the third interim
... Read moreRegulatory agencies across the globe, including the U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines
... Read moreManufacturers and companies exporting medical devices from Canada may be asked by foreign customers or foreign governments to supply certification
... Read moreAs a Canadian medical device license (MDL) holder, you are subject to an annual license renewal procedure. The renewal process
... Read moreThe advancement of technology is rapidly progressing, and the evolution can be observed all around us. As cutting-edge technology becomes
... Read moreIt’s that time of year again! Any domestic and foreign establishments registered with US FDA must renew their registration annually
... Read moreOn June 28, 2021, Health Canada opened a public consultation on a Unique Device Identification (UDI) system for medical devices
... Read moreWho Needs an MDSAP Certificate? Anyone looking to manufacture a Class II, III or IV medical device in Canada requires
... Read moreHealth Canada has published a consultation paper on proposed changes to the regulation and oversight of clinical trials for drug,
... Read moreCancellation of Medical Device Establishment Licence for A Non-compliance With Annual Licence Review Requirements On May 27, 2021 Health Canada
... Read moreAs of March 1, 2021, Interim Order No. 2 replaces Interim Order No. 1 Respecting the importation and sale of
... Read moreHealth Canada recently published an additional notice regarding all interim orders relating to COVID-19 and Medical Devices. This notice is
... Read moreEarlier this summer, Health Canada provided a notice to industry on the regulatory considerations for non-medical masks or face coverings,
... Read moreHealth Canada is not only the national regulatory authority for issuing health product marketing authorizations, but it also oversees and
... Read moreQuality Smart Solutions is a global consulting firm, engaged in providing strategic support for products including NHPs, pharmaceuticals, and medical devices, in areas such as Regulatory Support, Site Licensing, Clinical Development and more.