Expert Q&A – media

【EXPERT Q&A】Why do we need CE certification?

Drugdu.com expert’s response: The CE certification serves as a “passport” for products to enter the European market, with its core purpose being to ensure that products comply with the EU’s fundamental requirements for safety, health, and environmental protection, while also facilitating the free flow of goods within the EU internal market. The following are the main reasons and specific values for enterprises to pursue CE certification: I. Legal Compliance: Avoiding Market Access Barriers EU Mandatory Requirement: The CE mark is a mandatory certification symbol for product safety, health, and environmental protection in the EU. According to EU regulations (such as the Low Voltage Directive, Electromagnetic Compatibility Directive, and Machinery Directive), products without the CE mark are prohibited from being sold in the EU market. Avoiding Legal Risks: Products that fail to pass CE certification may face customs seizure, mandatory recalls, hefty fines, or even criminal penalties. For example, electronic and ...
- Source: drugdu
- 26
- July 4, 2025
【EXPERT Q&A】How is medical device software recognized and classified in the European Union?

Drugdu.com expert’s response: I. How to Determine if a Software is Medical Device Software? In simple terms, for the European Union (EU), a software is considered medical device software (MDSW) when it meets three conditions simultaneously: It Performs Medical Tasks For example, diagnosing diseases, monitoring conditions, treating patients, or assisting in surgeries. If it merely records exercise steps, reminds users to drink water, or sends notifications to doctors (without involving medical decision-making), it doesn’t qualify. Examples: A software that analyzes electrocardiogram (ECG) data to assess heart disease risk is medical device software; a fitness app that records daily step counts is not. It Processes Data The software should not just store or display data (such as an electronic medical record system). It must analyze, calculate, modify the data, and then generate medical-related results. Examples: A software that automatically marks tumor locations based on computed tomography (CT) images is medical device ...
- Source: drugdu
- 38
- July 2, 2025
【EXPERT Q&A】Why do drugs need to have a patent protection period?

Drugdu.com expert’s response: The reasons for setting a patent protection period for pharmaceuticals mainly include the following aspects: I. Encouraging Innovation and Research Investment High Risks and Costs: Pharmaceutical research and development (R&D) is a lengthy, complex, and costly process. It often takes several years or even decades from drug discovery, preclinical research, clinical trials to eventual market launch, and involves substantial financial investment. For instance, data indicates that the cost of developing a new drug can amount to hundreds of millions of US dollars or more. Patent Incentives: The patent protection period grants pharmaceutical developers exclusive market rights, enabling them to recoup R&D costs and generate profits through drug sales within a specified timeframe. This incentive mechanism encourages enterprises to invest more resources in new drug R&D, thereby driving innovation and development in the pharmaceutical industry. II. Ensuring Drug Quality and Safety Stringent Regulation: The R&D, production, and sale ...
- Source: drugdu
- 97
- June 30, 2025
【EXPERT Q&A】How to optimize the process of pharmaceutical trade?

Drugdu.com expert’s response: Optimizing the pharmaceutical trade process is a crucial measure to enhance the efficiency of the pharmaceutical supply chain, reduce costs, and ensure the quality and safety of pharmaceutical products. Below are some specific optimization strategies: I. Digital and Information Technology Upgrading Implement ERP Systems: Functions: Integrate modules such as procurement, inventory, sales, and finance to achieve real-time data sharing and process automation. Advantages: Improve data processing efficiency, reduce human errors, and enhance decision-making support capabilities. Apply Blockchain Technology: Functions: Ensure the traceability of pharmaceutical products from production to sale, recording information at every stage. Advantages: Enhance pharmaceutical safety, boost consumer trust, and facilitate regulatory oversight. Utilize Big Data Analytics: Functions: Analyze data on market demand, sales trends, inventory levels, etc. Advantages: Optimize procurement plans, reduce inventory backlogs, and improve capital turnover rates. II. Supply Chain Collaboration and Integration Establish Strategic Partnerships: Methods: Form long-term and stable cooperative ...
- Source: drugdu
- 100
- June 27, 2025
【EXPERT Q&A】How exactly does the improvement of medical detection technology help discover more potential diseases?

Drugdu.com expert’s response: The advancement of medical detection technologies enables the discovery of more potential diseases through various means, which are specifically reflected in the following aspects: High-Sensitivity Detection Technologies: High-sensitivity detection methods can detect minute changes in biomarkers at an earlier stage. For instance, high-sensitivity troponin detection technology can identify the release of troponin during the early phase of myocardial cell injury, thereby supporting the early diagnosis of acute coronary syndrome and myocardial infarction. This technology can uncover early lesions that might be missed by traditional methods. Multimodal Data Fusion and Comprehensive Analysis: By integrating data from multiple detection modalities, such as electrocardiograms (ECGs), echocardiograms, and blood tests, medical detection technologies can provide more comprehensive health information. This multimodal data fusion enhances diagnostic accuracy and helps identify potential disease risks that might be overlooked by a single detection method. Artificial Intelligence (AI) and Big Data Analytics: AI technologies can ...
- Source: drugdu
- 109
- June 25, 2025
【EXPERT Q&A】What are the characteristics of the medical device industry?

Drugdu.com expert’s response: The medical device industry is characterized by its interdisciplinary nature, knowledge-intensive and capital-intensive requirements, stringent regulation, substantial market potential, low industry concentration, and fierce competition. The details are as follows: Interdisciplinary Nature: It encompasses disciplines such as engineering, medicine, physics, biology, materials science, computer science, human-computer interaction, and aesthetics, resulting in a high R&D threshold. Knowledge-Intensive and Capital-Intensive: It is a typical technology-intensive industry, with its development highly reliant on continuous technological R&D and innovation, necessitating significant capital investment. For instance, the initial funding for a medium-sized medical device project can reach as high as 30 million yuan. Stringent Regulation: It is subject to strict laws and regulations. The R&D, production, distribution, and use of medical device products must comply with relevant national standards, industry standards, and regulatory requirements, with complete and traceable records required throughout the product lifecycle. Substantial Market Potential: Driven by factors such as ...
- Source: drugdu
- 107
- June 23, 2025
【EXPERT Q&A】Is CDMO service for medical devices reliable?

Drugdu.com expert’s response: Medical device Contract Development and Manufacturing Organization (CDMO) services are reliable when they operate with strong compliance, technical expertise, and resource integration capabilities. However, potential risks such as intellectual property (IP) protection, industry trust, and policy changes should be noted. Below is a detailed analysis: Advantages of Medical Device CDMO Services High Specialization: Medical device CDMO companies typically possess extensive professional knowledge and practical experience, enabling them to provide one-stop services for medical device enterprises, ranging from product R&D and manufacturing to technical solutions. Cost Reduction: By outsourcing R&D and production processes, medical device enterprises can reduce investments in equipment, personnel, and facilities, thereby lowering R&D costs. Meanwhile, CDMO companies can leverage their advantages in large-scale production to reduce manufacturing costs and offer more competitive pricing to clients. Accelerated Market Launch: CDMO companies have professional R&D teams and rich practical experience, enabling them to provide efficient R&D ...
- Source: drugdu
- 117
- June 20, 2025
【EXPERT Q&A】How to register a drug with the DMF in the United States?

Drugdu.com expert’s response: The registration of a Drug Master File (DMF) for pharmaceuticals in the United States is a complex process involving multiple steps and requirements. Below are the main procedures and key points for registration: I. Determine the DMF Type Select the appropriate DMF type based on the product characteristics. Common types include: Type II: Manufacturing and control information for Active Pharmaceutical Ingredients (APIs) and intermediates, which is the most common type. Type III: Packaging materials. Type IV: Excipients. Type V: Information specifically requested by the FDA. II. Prepare Required Documents Cover Letter: Introduce the content and purpose of the DMF, including the DMF type. DMF Holder Information: Company name, address, contact person, etc. Letter of Authorization (LOA): If another company will reference this DMF, provide an LOA. Manufacturing Process Description: Detailed description of the production process and key process parameters. Quality Standards: Include specifications, impurities, and physicochemical properties, ...
- Source: drugdu
- 56
- June 18, 2025
【EXPERT Q&A】What are the mandatory certifications for product exports to the Middle East?

Drugdu.com expert’s response: I. Saudi Arabia SASO Certification: This certification involves pre-shipment inspection and conformity verification for products imported into the Saudi market, ensuring that imported goods comply with Saudi quality standards. SABER Certification: A system introduced by Saudi Arabia for online application of customs clearance certificates. It is used for product registration, issuance, and obtaining Certificates of Conformity (COC). SABER certification includes a Product Certificate (PC) and a Shipment Certificate (SC). All goods exported to Saudi Arabia must apply for an SC through the SABER system before the goods arrive at the port. II. Gulf Cooperation Council (GCC) Countries GCC Certification (G-MARK Certification): Applicable to the six Gulf countries, including Saudi Arabia, the United Arab Emirates, and Kuwait. It requires products to comply with the unified Gulf Standards (GSO). Products such as low-voltage equipment, toys, and building materials are involved, and they need to pass tests conducted by GSO-authorized ...
- Source: drugdu
- 85
- June 16, 2025
【EXPERT Q&A】What is the effect of rukang saltuzumab on EGFR-mutated lung cancer?

Drugdu.com expert’s response: I. Clinical Research Data KL264-01 Study: In the subgroup analysis targeting EGFR-mutated non-small cell lung cancer (NSCLC) patients, the objective response rate (ORR) of sacituzumab tirumotecan as a monotherapy reached as high as 55%, with a median progression-free survival (PFS) of 11.1 months. These results were significantly superior to those in EGFR wild-type patients, who had an ORR of 24% and a median PFS of 5.3 months. SKB264-II-08 Study: Among 64 previously treated EGFR-mutated NSCLC patients, sacituzumab tirumotecan achieved an ORR of 34%, a disease control rate (DCR) of 84%, a median duration of response (DOR) of 9.6 months, a median PFS of 9.3 months, and a 1-year overall survival (OS) rate of 79%. OptiTROP-Lung03 Study: The sacituzumab tirumotecan group demonstrated a confirmed ORR of 45.1%, significantly higher than the 15.6% in the docetaxel group. The median PFS was 6.9 months, significantly longer than the 2.8 months ...
- Source: drugdu
- 84
- June 13, 2025

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