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【EXPERT Q&A】What is the basic process of Class II medical device registration certificate application?

Drugdu.com expert’s response: The basic process for applying for the registration certificate of Class II medical devices is as follows: 1.Document Preparation: Prepare all necessary documents for the application, including technical documentation for the product, clinical trial reports, quality management system documents, etc. 2.Application Submission: Submit the application documents to the National Medical Products Administration (NMPA) or relevant local drug regulatory authority. The application documents should include company information, product information, technical documentation, clinical trial reports, etc. 3.Preliminary Review: The drug regulatory authority conducts a preliminary review of the submitted application documents to ensure completeness and compliance with requirements. 4.Acceptance: After the preliminary review, the drug regulatory authority formally accepts the application and issues an acceptance notice. 5.Technical Review: Conduct a technical review of the application documents to assess the safety, efficacy, and quality control system of the product. 6.Clinical Evaluation: If necessary, conduct a clinical evaluation of the product ...
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- April 8, 2024
FCE Pharma 2024

Organiser: Nuremberg Exhibition Co. LTD Time: 4 – 6 June 2024 address：Centro de Exposições Imigrantes Rodovia dos Imigrantes, Km 1,5 São Paulo – SP Exhibition hall: São Paulo Expo Product range: Apis: vitamins, hormones, antipyretic analgesics, digestive system drugs, anti-infective drugs, anti-parasitic drugs, cardiovascular system drugs, intermediates Medical equipment: medical packaging materials, PVC/PVDC composite sheet, PVC hard sheet, PS sheet, packaging anti-counterfeiting technology information, label technology, label filling machine, packaging container molding filling and sealing machine, wrapping machine, paper film packaging machinery, etc Other: large infusion equipment production line, dryer, water treatment equipment, refrigeration compressor, distillation equipment, sterilization equipment, tablet press, coating machine, plastic equipment, crystallization equipment, etc About FCE Pharma： FCE Pharma is the premier pharmaceutical technology exhibition in South America. In addition to bringing together new technologies, trends and technologies for the pharmaceutical industry, products and services, FCE Pharma also offers high-quality content to exchange experiences with professionals, case ...
- Source: drugdu
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- April 8, 2024
Profound Medical, Siemens Healthineers collab on ultrasound ablation

BY SEAN WHOOLEY The TULSA-PRO system from Profound Medical. [Image from Siemens Healthineers]Profound Medical (Nasdaq:PROF) announced today that it entered into a non-exclusive collaboration with Siemens Healthineers. The two companies aim to lay the groundwork for Profound to begin marketing a complete therapeutics solution. They want to combine the Profound TULSA-PRO system with the Siemens Magnetom Free.Max magnetic resonance (MR) scanner. While this combination falls under the remit of Profound’s own sales force, the company also plan to market TULSA-PRO as a standalone offering. This enables customers to use the technology with the MR hardware of their choice. TULSA-PRO performs the company’s transurethral ultrasound ablation (TULSA) procedure. It employs real-time MR guidance for precision while killing targeted prostate tissue through sound absorption technology. The system enables surgeons to ablate whole- or partial-gland prostate tissue in patients with low- intermediate- or high-risk prostate cancer. It also treats benign prostatic hyperplasia (BPH). ...
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- April 7, 2024
Bessel launches accelerator program for medtech startups

BY JIM HAMMERAND Bessel and an Alabama tech hub today said they are launching Hatch Powered by Bessel, an accelerator program for medtech startups. Applications are now open for the 10-week program, which starts in Fairhope, Alabama, this summer. The accelerator “combines the passion of startup founders, the guidance of seasoned medical device experts, and the burgeoning startup ecosystem and investment in Alabama,” Bessel said in a news release. “… The program aims to equip medtech startups to create sustainable and scalable innovations—breakthroughs that scale—and to give founders the entrepreneurial resource ecosystem they need for long-term success.” Startups selected for the program will receive a travel stipend, access to events and workshops, and guidance on strategy, fundraising and execution from lifescience industry entrepreneurs who will act as mentors and advisors. The startups may be offered funding for equity by Hatch Fairhope after the cohort concludes with finale events in Fairhope, ...
- Source: drugdu
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- April 7, 2024
Cambridge researchers begin new trial for oesophageal cancer screening

Researchers at Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge have announced the launch of the BEST4 trial to evaluate a capsule sponge test to prevent oesophageal cancer. Funded by Cancer Research UK and the National Institute for Health and Research, the capsule sponge could see routine screening introduced into the NHS if successful. Responsible for around 9,200 new cases every year in the UK, oesophageal cancer occurs in the long, hollow tube that runs from the throat to the stomach, known as the oesophagus. The BEST4 trial, launched at Addenbrooke’s Hospital, is investigating whether the pill-on-a-thread test can be used to screen or monitor those most at risk of the disease. The ten-minute test is used for Barrett’s oesophagus, sometimes called a pre-cancerous condition, which is usually identified via an endoscopy and a biopsy at a hospital, following a GP referral. The process is time-consuming, unpleasant ...
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- April 7, 2024
Kanabo and City Dock Pharmacy team up

Kanabo Group has linked up with City Dock Pharmacy in London, to introduce a walk-in pain clinic offering specialised medicines, including medicinal cannabis. The partnership will cater for patients who are eligible for alternative therapies, as traditional treatments have not delivered improvements. The facility, which will be situated at City Dock Pharmacy in Wapping, will deliver both walk-in and appointment-related services, and becomes the UK’s first walk-in clinic for pain management. The clinic will represent an extension of Kanabo’s ‘Treat It’ online platform, allowing onsite pharmacists will also be able to guide patients through the medicinal cannabis treatment options. Meanwhile, the clinic will also support the unrolling of personalised plans for the growing number of chronic pain sufferers across the UK. At present, such individuals often face difficulties accessing medical treatments due to long waiting times and affordability. The latest development is part of Kanabo’s wider ambition to extend its ...
- Source: drugdu
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- April 7, 2024
CellVoyant secures £7.6 million AI stem cell boost

CellVoyant – an AI biotechnology spin-out from the University of Bristol – has announced a £7.6 million funding round. Led by Octopus Ventures – with additional participation from Horizons Ventures, Air Street Capital and Verve Ventures – the funding represents the first stage in commercialising CellVoyant’s first of its kind AI and imaging platforms. Meanwhile, the company now aims to enable the rapid development of novel cell therapies. Stem cells unlock a wide range of treatment possibilities that have not historically been available to patients. Indeed, current treatments tend to act on the body’s existing cells, while stem cells have the potential to develop into different cell types in the body – replacing dysfunctional cells or regenerating damaged tissues and organs. CellVoyant’s platform combines advanced AI with live cell imaging to address pain points. The technology can extract spatial and temporal information in real-time from hundreds of millions of cells. ...
- Source: drugdu
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- April 7, 2024
Aston University receives £10m for membrane institute

Aston University is on course to create the Aston Institute for Membrane Excellence (AIME) – a cross-disciplinary facility to develop novel biomimetic membranes – having received £10m from Research England. The institute will be led by Professor Roslyn Bill, from the School of Biosciences, along with Professor Paul Topham from the department of Chemical Engineering and Applied Chemistry. Both biological and synthetic membranes are significant across several many sectors. Indeed, the world’s top ten selling human medicines all target proteins in biological membranes, while synthetic polymer membranes are commonly used in the water purification industry. The AIME believes that the full potential of membranes will only be realised by an interdisciplinary group which spans biology, physics and chemistry and that can investigate membranes holistically. Professor Bill, a European Research Council (ERC) Advanced grantee leads Aston Membrane Proteins and Lipids (AMPL) research centre of excellence that studies the structure and function ...
- Source: drugdu
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- April 7, 2024
Disco tunes into new cancer drug targets

EUR 20m to identify new targets and develop first in class drugs DISCO Pharmaceuticals – a company specialising in unlocking the surfaceome of cancer cells at scale – has raided EUR 20m to identify new targets and develop first in class drugs. The funding round was backed by a formidable investor syndicate, including Sofinnova Partners, Panakes Partners, M Ventures and AbbVie Ventures. The development of new treatment modalities in oncology is increasing, however, the lack of cell surface targets limits the application to some clinically effective targets. Also, the development of new biologics, such as bi-specific antibodies and antibody drug conjugates, is increasing and there are currently less than 30 molecular targets, which form the basis of all antibody-based therapies. Consequently, there is a significant need to identify novel cancer-selective targets and target pairs. DISCO’s surfaceome mapping platform transforms the current approach of target discovery for large molecule R&D. This ...
- Source: drugdu
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- April 7, 2024
Poolbeg’s cytokine release syndrome drug shows potential

Data supports Poolbeg’s strategic expansion of POLB 001 Poolbeg – a company focused on innovative medicines – has announced promising in vivo results for POLB 001 in treating cancer immunotherapy-induced cytokine release syndrome (CRS). The drug showed efficacy in significantly reducing the condition in an animal model with CRS symptoms. The data further supports Poolbeg’s strategic expansion of the phase II-ready POLB 001 while the emerging results facilitate the expansion of patent applications for the therapy. As an oral therapy to prevent or treat CRS, POLB 001 has the potential to enable a broader use of cancer immunotherapies in an outpatient setting. Meanwhile, cancer immunotherapies are being developed through a considerable range of haematological malignancies, solid tumours and immune inflammatory diseases, which represents an even greater market opportunity. Due to the CRS risk – which can be life threatening – administration of cancer immunotherapies, such as bispecific antibodies, is currently ...
- Source: drugdu
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- April 7, 2024

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