The Vietnamese Ministry of Health (MoH) published a draft decree (download link, in Vietnamese) intended to replace Decree No. 36/2016/ND-CP​ and its amendments, which form the legal framework for regulating medical devices in Vietnam. The draft, released as Official Dispatch No. 2271/BYT-TB-CT, consolidates the amendments made to the current decree and introduces new sections addressing
0 Comments
The roles of CEN, Cenelec and HAS consultants Regarding development of hENs for medical devices, these efforts fall either to the European Committee for Standardization (CEN), which covers most types of medical devces, as well as the European Committee for Electrotechnical Standardization (Cenelec), which focuses on medical electrical equipment. Under the current Directives, European Commissioners
0 Comments
In 2020, and for the past few years, our team has published blog posts summarizing the latest expectations that US Food and Drug Administration (FDA)’s Human Factors reviewers have shared during the Human Factors and Ergonomics Society (HFES) Health Care Symposium. Here’s Part 1 of our 2021 edition, focused on what we learned from individuals
0 Comments
The Central Drugs Standard Control Organization (CDSCO), India’s medical device market regulator, has postponed deadlines for regulating implantable devices and other medical products for which manufacturers or importers have already applied for licenses under the Medical Device Rules 2017. According to a recent CDCSO order, Notification S.O. 775(E) establishing regulation of the following medical devices
0 Comments
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published a document (links in Japanese) explaining the updated requirements for package insert digitization. Starting on August 1, 2021, package inserts for all classes of medical devices and IVDs must be posted to the Medical Device Safety Information Posting System on the PMDA website, allowing them to be viewable using
0 Comments
Following up on our earlier post providing details on Taiwan’s new medical device regulations, the following is a summary of noteworthy details that have subsequently become available. These are compiled from various announcements and guidance documents (all links in Chinese) published by the Taiwan Food and Drug Administration (TFDA). Unless otherwise specified, these changes will
0 Comments
The European Commission’s Medical Device Coordination Group (MDCG) has published a Q&A reference document covering clinical investigation requirements under the Medical Devices Regulation (MDR). The new MDCG document includes 28 questions and answers, providing additional clarity on several issues regarding the MDR’s substantial clinical investigation requirements. Manufacturers preparing for the MDR’s May 26, 2021 final
0 Comments
Switzerland’s Federal Office of Public Health (FOPH) announced that the Swiss Federal Council has opened a consultation on the In Vitro Diagnostics Ordinance (IvDO) and the corresponding amendments to the Ordinance on Clinical Trials for Medical Devices (ClinO-MD). This legislation aims to harmonize Switzerland’s regulatory system for IVDs to the European Union’s In Vitro Diagnostic
0 Comments
Dyno Therapeutics, a Cambridge biotech that uses artificial intelligence techniques to develop gene therapies, said Thursday that it has raised $100 million from investors. The company uses machine learning to design a type of gene therapy “vector,” or carrier, aiming to make treatments that are easier to deliver and more effective. Dyno said the funding would
0 Comments
In a surprising move, the Biden administration has said it will support a controversial proposal to temporarily waive intellectual property rights for Covid-19 vaccines in a bid to increase global supplies of desperately needed doses. The proposal, which was introduced before the World Trade Organization last fall by South Africa and India, would cover patents, industrial
0 Comments
The Massachusetts attorney general has filed a lawsuit against Publicis Health, one of the world’s largest health care communications companies, for allegedly designing and placing unfair and deceptive “marketing schemes” to help Purdue Pharma sell more of its OxyContin painkiller. The state claimed that, from 2010 through 2019, Publicis (PUBGY) collected more than $50 million
0 Comments
Off-the-shelf treatments for cancer made from genetically engineered T cells and natural killer, or NK, cells have each shown promise in clinical trials. On Thursday, two biotech companies — Nkarta and CRISPR Therapeutics — announced a partnership that aims to merge the two immune-cell approaches together. The ultimate goal of the equal partnership formed by
0 Comments