Expert Q&A – Page 5 – media

【EXPERT Q&A】The Critical Necessity of Usability Engineering Reports for Medical Devices

Drugdu.com expert’s response: The usability engineering report for medical devices holds immense significance as it serves as a pivotal element in ensuring product safety, efficacy, compliance, and market competitiveness. The following analysis unfolds across four key dimensions: regulatory requirements, product risk control, user experience optimization, and enhancement of market competitiveness. I. Regulatory Mandates: The “Passport” to Compliance International Regulatory Framework FDA (United States): Mandates that medical device design adheres to the “human-computer interaction safety principle.” 21 CFR Part 820 explicitly stipulates the necessity of usability testing to validate design rationality, with non-compliance potentially leading to product recalls or market access hindrances. EU MDR (European Union): Incorporates “usability engineering” into the General Safety and Performance Requirements (GSPR), requiring manufacturers to furnish documentation on user interface design, risk analysis, and user testing as essential materials for CE certification. ISO 14971: This international risk management standard explicitly mandates the inclusion of “use errors” ...
- Source: drugdu
- 90
- September 5, 2025
【EXPERT Q&A】What is the outlook for medical CDMO?

Drugdu.com expert’s response: The medical Contract Development and Manufacturing Organization (CDMO) industry boasts a broad prospect and is now at a critical juncture of transitioning from “scale expansion” to “value creation”. Technological innovation, green production, and global layout will be the keys for enterprises to break through. The specific analysis is as follows: I. Demand Side: Expansion of Global Pharmaceutical R&D Pipelines and Growth Driven by Emerging Therapies Continuous Growth of Global R&D Pipelines In 2025, the number of global pharmaceutical R&D pipelines will surpass 25,800, representing a year-on-year increase of 4.6%, with biologics accounting for over 60%. This trend directly drives the recovery of CDMO demand, particularly for small-molecule CDMOs (which are returning to growth after shaking off the high base effect of COVID-19 orders) and peptide CDMOs (which have become one of the fastest-growing sectors due to the explosion of the GLP-1-based antidiabetic drug market). Emerging Therapies Reshaping ...
- Source: drugdu
- 196
- September 3, 2025
【EXPERT Q&A】In what aspects is trimethylolpropane used?

Drugdu.com expert’s response: Trimethylolpropane (TMP), as a critical fine chemical product, demonstrates extensive application value across multiple industrial sectors. Its core uses can be summarized as follows: I. Resin Synthesis: A Key Raw Material for Enhancing Material Performance Alkyd and Polyurethane Resins: TMP serves as a cornerstone raw material for synthesizing alkyd and polyurethane resins. Its three hydroxymethyl groups enable cross-linking reactions with organic acids or diisocyanates, significantly improving resin hardness, abrasion resistance, chemical resistance, and weatherability. For example, in automotive coatings, TMP-containing resins enhance UV and acid rain resistance, extending vehicle lifespan. Unsaturated Polyester and Epoxy Resins: As a chain extender or cross-linker, TMP increases polymer molecular weight, enhancing mechanical properties (e.g., tensile strength, impact resistance) and thermal stability. It is widely applied in aerospace, electronics, and other high-end fields. Coatings and Inks: Optimizing Performance and Processes Coatings Industry: TMP is a vital component in high-performance coatings, improving drying ...
- Source: drugdu
- 219
- September 1, 2025
【EXPERT Q&A】What are the development trends of the complex formulation industry?

Drugdu.com expert’s response: Development Trends in the Complex Formulation Industry I. Complex formulation processes will gain broader development opportunities Formulation innovation can extend the lifecycle of new molecular entities while enhancing the safety, efficacy, and patient compliance of existing products, making it a focal point of pharmaceutical R&D. For instance, conventional leuprolide formulations have gradually been phased out, whereas leuprolide microspheres remain a first-line treatment for prostate cancer and uterine fibroids. In 2022, the market size of leuprolide microspheres in China reached approximately RMB 4.8 billion, with steady year-on-year growth. China’s 14th Five-Year Plan for the Pharmaceutical Industry emphasizes the need to prioritize the development of complex formulation technologies for chemical drugs, including high-selectivity, long-acting controlled-release injectables (e.g., microspheres) and oral formulations such as controlled-release and multi-particulate systems. Enterprises mastering innovative complex formulation processes are poised to stand out and secure greater profit margins. II. Significant potential for import substitution by domestic ...
- Source: drugdu
- 211
- August 29, 2025
【EXPERT Q&A】How to handle the filing for Class I medical device products?

Drugdu.com expert’s response: Medical Device Class I Product Filing Process I. Pre-Filing Preparation Confirm Product Classification Ensure the product falls within the scope of the Class I Medical Device Product Catalog or the In Vitro Diagnostic Reagent Classification Sub-Catalog. If the product is outside these catalogs, apply to the National Medical Products Administration (NMPA) for classification determination. Filing can proceed only after confirmation as a Class I medical device. Prepare Filing Documents The following core materials must be submitted (subject to local regulatory requirements): Filing Form: Completed and stamped with the enterprise’s official seal or signed by the legal representative. Enterprise Qualification Documents: Business license duplicate. Legal representative’s identification. Product Technical Documents: Product Technical Requirements (prepared per the Guidelines for Drafting Technical Requirements for Medical Devices), specifying functional and safety indicators, as well as testing methods. Product Inspection Report (self-tested or commissioned testing, including product information, testing basis, and results). Instructions for Use and Label Samples (compliant ...
- Source: drugdu
- 199
- August 27, 2025
【EXPERT Q&A】Are quality management systems in the medical device industry effective?

Drugdu.com expert’s response: The quality management system (QMS) in the medical device industry is not only valuable but also a core element in ensuring product safety and effectiveness, meeting regulatory requirements, enhancing corporate competitiveness, and promoting the healthy development of the industry. Its importance is reflected in the following aspects: Ensuring Patient Safety and Product Effectiveness Risk Control: Medical devices directly interact with the human body, and quality defects can lead to severe health risks (e.g., surgical instrument fractures, implant failures, diagnostic device misdiagnoses). The QMS reduces risks to acceptable levels through systematic risk assessments (e.g., Failure Mode and Effects Analysis, or FMEA), design controls, and production process monitoring. Performance Verification: Rigorous testing and validation (e.g., biocompatibility testing, electrical safety testing, performance stability testing) ensure that products meet their intended purposes and prevent medical accidents caused by functional failures. Meeting Global Regulatory and Compliance Requirements International Standard Mandates: Major global ...
- Source: drugdu
- 179
- August 25, 2025
【EXPERT Q&A】What are the registration and regulatory requirements that IVD test reagents for Chikungunya virus need to comply with?

Drugdu.com expert’s response: The registration and regulatory requirements for IVD test reagents for Chikungunya virus vary across different countries and regions. Below are the specific requirements for some major countries and regions: European Union Regulatory Compliance: Must comply with the In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017/746). Product Classification: According to the classification rules of the IVDR, IVD test reagents for Chikungunya virus are typically classified as Class C or Class D, depending on their intended use and risk level. Review and Certification: For Class C or Class D products, review and certification by a Notified Body are required. Quality Management System: Companies must establish a quality management system that complies with the ISO 13485 standard and ensure that the product meets relevant basic requirements. Submission of Technical Documentation: Technical documentation, including product performance evaluation reports, clinical evidence, labels, and instructions, must be submitted. CE Marking and ...
- Source: drugdu
- 216
- August 22, 2025
【EXPERT Q&A】Why are glucocorticoids (such as prednisone and deflazacort) the standard therapeutic drugs for Duchenne Muscular Dystrophy (DMD)?

Drugdu.com expert’s response: Glucocorticoids (such as prednisone and deflazacort) are the standard therapeutic drugs for Duchenne muscular dystrophy (DMD), primarily due to their well-established efficacy in delaying disease progression, improving motor function, and prolonging survival. Their mechanisms of action also align closely with the pathological features of DMD. Below is a detailed analysis of the reasons: The only disease-modifying drugs validated by evidence-based medicine Prolonged motor capacity: Multiple studies have demonstrated that glucocorticoids significantly delay the decline in motor function in DMD patients. For example: Children treated with prednisone exhibit superior muscle strength compared to untreated counterparts, with independent walking duration extended by over three years. Deflazacort treatment delays the age at which children lose ambulation by 1.4-2.5 years, increases the 6-minute walk distance, and improves pulmonary function. Delayed complications: Glucocorticoids reduce the risk of scoliosis (11.6% in the treatment group vs. 33.2% in the untreated group), postpone the onset ...
- Source: drugdu
- 208
- August 20, 2025
【EXPERT Q&A】How can one query the natural medicines approved in the past decade and their sources through the FDA drug approval database?

Drugdu.com expert’s response: To query FDA-approved natural drugs and their sources over the past decade through the FDA drug approval databases, the following systematic workflow can be followed, integrating FDA official resources with natural product classification logic for efficient retrieval: I. Define Search Objectives and Natural Drug Categories Natural drugs typically refer to active ingredients directly derived from plants, microorganisms, marine organisms, or minerals, as well as their structurally modified derivatives. Key focus areas include: Plant-derived: Examples include paclitaxel (from Pacific yew) and artemisinin (from sweet wormwood). Microorganism-derived: Examples include erythromycin (from actinomycetes) and cyclosporine (from fungi). Marine-derived: Examples include trabectedin (from sea squirts) and eribulin (from sponges). II. Leverage FDA Core Databases for Screening Drugs@FDA Database Steps: Access the database and select “Advanced Search”. Set the “Approval Date Range” to the past decade (e.g., January 1, 2015, to December 31, 2025). Enter natural product-related keywords in the “Active Ingredient” ...
- Source: drugdu
- 167
- August 18, 2025
【EXPERT Q&A】What does the release of the management regulations for the filing of Internet drugs and medical devices mean?

Drugdu.com expert’s response: The issuance of the Administrative Provisions on the Filing of Internet Information Services for Drugs and Medical Devices marks a new phase in China’s regulatory efforts to standardize and strengthen oversight of internet-based information services for drugs and medical devices. Its core significance is reflected in the following aspects: I. Regulatory Framework Upgrade: Decentralized Management Enhances Efficiency Clarified Division of Responsibilities National Medical Products Administration (NMPA): Oversees nationwide filing guidance and supervision, establishing unified standards. Provincial Medical Products Regulatory Authorities: Responsible for specific filings and local supervision, creating a “national coordination + local implementation” model that ensures policy consistency while enhancing regional regulatory flexibility. Refined Filing Units: Filings are conducted on a per-website or per-app basis to ensure traceability of information on each platform and prevent regulatory gaps caused by “one license for multiple uses.” Strengthened Dynamic Oversight Real-Time Updates for Filing Changes: Key information, such as the host ...
- Source: drugdu
- 218
- August 15, 2025

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