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【EXPERT Q&A】What is the medical device registration process?

Drugdu.com expert’s response: The process for medical device registration typically involves the following steps: 1.Document Preparation: Gather all necessary documents and information, including product technical data, manufacturing processes, and quality management system documents. Requirements may vary by country or region. 2.Application Form Completion: Fill out the medical device registration application form, providing basic product information, technical characteristics, and manufacturing details. 3.Technical Evaluation: Submit the product’s technical documentation for evaluation by relevant authorities, assessing safety, efficacy, and performance indicators. 4.Clinical Trials (if required): Some medical devices require clinical trials to validate their safety and effectiveness. Applicants must conduct trials as per regulations and submit trial reports. 5.Quality Management System Review: Submit quality management system documents for review. Upon successful audit, obtain quality management system certification. 6.Submission of Registration Application: Submit the completed application form and relevant documents to the competent authority or agency. 7.Review and Approval: The competent authority or agency ...
- Source: drugdu
- 137
- April 25, 2024
Bristol Myers Squibb, Cellares Ink $380M Deal to Manufacture CAR T-Cell Therapies

Don Tracy, Associate Editor Per the agreement, Cellares will integrate and automate some of Bristol Myers Squibb’s CAR T-cell therapies into its Cell Shuttle program. Bristol Myers Squibb (BMS) and Cellares announced that they have agreed to terms on a $380 million deal to enhance the manufacturing capabilities for chimeric antigen receptor (CAR) T-cell therapies. According to the companies, the deal will see Cellares incorporate a number of BMS’ therapies into its Cell Shuttle platform, which includes fully automated systems. With the deal aiming to improve access to CAR T-cell therapies to patients at a faster rate, BMS will be given exclusive use of Cellares’ smart factories across the United States, Europe, and Japan. “The agreement with Cellares is our latest step forward in support of our comprehensive strategy to unlock the full potential of CAR T therapy to deliver transformative treatments to as many patients as possible, as quickly ...
- Source: drugdu
- 109
- April 24, 2024
Boehringer Ingelheim Strikes Regenerative Med R&D Deal Spanning MASH & More Liver Diseases

The first FDA-approved MASH drug doesn’t treat patients with liver cirrhosis. A new Boehringer Ingelheim/Ochre Bio collaboration is researching regenerative medicines that could treat patients in this most advanced stage of the fatty liver disease. By Frank VinluanThe liver is the only organ in the human body capable of regenerating itself. Boehringer Ingelheim has begun a research alliance with a startup to see if its technology can produce new therapies that tap into the liver’s capacity for regeneration and repair. Boehringer is committing to pay Ochre Bio to up to $35 million to begin the partnership, which is focused on identifying, characterizing, and validating multiple novel regenerative targets for chronic liver diseases. Specific targets were not disclosed, but Monday’s announcement describes the deal as a multi-target, multi-year collaboration. Ochre develops RNA medicines for chronic liver diseases. The Oxford, U.K.-based startup hasn’t disclosed details about its internal pipeline, but the company ...
- Source: drugdu
- 95
- April 24, 2024
GenFleet Therapeutics Announces FDA’s Clinical Trial Approval for GFH925 (KRAS G12C Inhibitor) Monotherapy in Phase III Registrational Study Treating Metastatic Colorectal Cancer

SHANGHAI, April 19, 2024 /PRNewswire/ — GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, announced US Food and Drug Administration (FDA) has granted the clinical trial approval for GFH925 (KRAS G12C inhibitor) in a multi-center, open-label, randomized and controlled phase III study treating refractory metastatic colorectal cancer (CRC) patients. It is the first phase III trial of KRAS G12C inhibitor monotherapy targeting CRC patients worldwide, with GFH925 being the first G12C inhibitor that received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for previously treated advanced CRC. GFH925 was also granted BTD and New Drug Application acceptance with Priority Review Designation by NMPA for previously treated advanced non-small cell lung cancer（NSCLC）patients with G12C mutation. The trial (GFH925X0301) will enroll refractory metastatic CRC patients harboring KRAS G12C mutation who have progressed or experienced disease recurrence on or after at least two prior ...
- Source: drugdu
- 120
- April 24, 2024
Focusing on China, Novartis Helps Promote the Development of the Radiopharmaceutical Industry

Today, the 2024 Conference on Innovative Development of Radiopharmaceuticals, organized by China Isotope and Radiation Industry Association (CIRIA), was held in Beijing. During the conference, China Isotope and Radiation Industry Association (CIRIA) established the Radiopharmaceutical Branch and held the first meeting of the First Council of the Branch, which was attended by leaders and representatives from research institutes, universities, medical institutions and enterprises in the field of radiopharmaceuticals in China. As a pioneer and “frontrunner” in the field of global radiopharmaceuticals, Novartis not only takes the lead in occupying the R&D plateau of radioligand therapy (RLT) and leading the domestic and international R&D track of RLT, but also actively promotes the construction and improvement of the industry in the field of radiopharmaceuticals based on its own industrial status and international influence. Ms. Luo Ya, Head of Value Access Department of Novartis China, participated in the meeting as Vice Chairman of ...
- Source: drugdu
- 86
- April 24, 2024
CureVac and MD Anderson Cancer Center partner to develop new cancer vaccines

Both will develop cancer vaccine candidates in selected haematological and solid tumour indications CureVac and the University of Texas’s MD Anderson Cancer Center have announced a co-development and licensing agreement to develop novel messenger ribonucleic acid (mRNA)-based cancer vaccines. The strategic collaboration will focus on the development of differentiated cancer vaccine candidates in selected haematological and solid tumour indications with high unmet medical needs. Solid tumour cancer, such as sarcoma, carcinoma and lymphoma, is characterised by an abnormal mass of tissue that usually does not contain cysts or liquid areas. Haematologic cancer, otherwise known as blood cancer, including leukaemia, lymphoma and multiple myeloma, begins in blood-forming tissues such as the bone marrow or in the cells of the immune system. Under the terms of the agreement, MD Anderson will be responsible for conducting phase 1/2 studies of the selected promising validated cancer vaccine candidates and the completion of investigational new ...
- Source: drugdu
- 116
- April 24, 2024
New clinical trial aims to investigate skin patches to spot lung transplant rejection

Involving 152 patients, the SENTINEL trial aims to cut lung transplant rejection by up to 50% A new clinical trial being led by the University of Oxford’s Surgical Trial Units in collaboration with NHS Blood and Transplant and five UK lung transplant centres will investigate whether skin patches can be used as an early warning system to detect lung transplant rejection. The SENTINEL trial is being funded by £2m in partnership with the Medical Research Council and the National Institute for Health and Care Research. Lung transplant rejection is commonly monitored through lung function tests, blood tests, X-rays and lung biopsies. However, until it is advanced, lung transplant rejection can be challenging to identify. The new trial aims to investigate the new early warning system to identify early signs of rejection to be rolled out to all lung transplant recipients, cutting rejection by up to 50%. Set to be carried ...
- Source: drugdu
- 79
- April 24, 2024
Use of Popular Pain Reliever During Pregnancy Not Linked to Neuro Disorders in Kids

Questions about whether acetaminophen use during pregnancy can lead children to develop neurological problems have sparked scientific inquiry and litigation. Lawsuits are continuing, but a new National Institutes of Health-sponsored study has results that show no causal link between acetaminophen and neurodevelopmental disorders. By Frank Vinluan When women experience pain or fever during pregnancy, many clinicians recommend acetaminophen for relief. But concerns about a possible link between these medicines and neurodevelopmental disorders have lingered. A multi-year study sponsored by the National Institutes of Health has results that add to the scientific consensus that these medicines aren’t the cause of neurodevelopmental problems. Acetaminophen is the active pharmaceutical ingredient in some prescription products and popular over-the-counter pain relievers, notably Tylenol and Excedrin. While nonsteroidal anti-inflammatory drugs offer an alternative approach to pain relief, these drugs aren’t recommended during pregnancy because they can cause low levels of amniotic fluid among other problems. The ...
- Source: drugdu
- 117
- April 23, 2024
FDA Approves Takeda’s Subcutaneous Form of Entyvio as a Maintenance Therapy in Adults with Moderately to Severe Crohn Disease

Don Tracy, Associate Editor Approval was based on positive data from Takeda’s Phase III VISIBLE 2 study, which displayed long-term clinical remission in approximately half of patients with Crohn disease receiving Entyvio. The FDA has approved Takeda Pharmaceuticals’ subcutaneous (SC) form of Entyvio (vedolizumab) as a maintenance therapy for adults with moderately to severely active Crohns disease (CD) following initial intravenous (IV) induction therapy. The expanded approval for an SC form of the drug was based on results from the randomized, double-blind, placebo-controlled Phase III VISIBLE 2 trial, which evaluated 409 patients who were treated with an injection of Entyvio or placebo every two weeks. At the end of the trial, 48% of patients treated with Entyvio experienced clinical remission.1,2 “Crohn’s disease is a complex and usually progressive disease for which an appropriate management plan is critical. My primary goal as a clinician is always to get patients to achieve ...
- Source: drugdu
- 105
- April 23, 2024
Low-Cost Point-Of-Care Diagnostic to Expand Access to STI Testing

Gonorrhea ranks as the second most commonly reported bacterial sexually transmitted infection (STI), with around 82 million global cases in 2020. The infection can lead to severe health consequences like pelvic inflammatory disease, chronic pelvic pain, and infertility. Many patients may not show symptoms, leading to underreported cases and highlighting the need for more accessible, accurate, and cost-effective diagnostic solutions. Now, a new point-of-care test aims to expand access to STI testing by providing affordable, accurate, and convenient diagnosis. Scout (Santa Clara, CA, USA) is developing the STI Scout test to identify and distinguish between Neisseria gonorrhoeae (Ng) and Chlamydia trachomatis (Ct). This new test delivers results in just 30 minutes at a cost expected to be less than half that of current testing methods. STI Scout can use either first void urine samples or vaginal swabs. The test runs on the Scout Hub device and is integrated with the ...
- Source: drugdu
- 87
- April 23, 2024

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