Expert Q&A – Page 6 – media

【EXPERT Q&A】FDA small business application, what are the tips and guidelines?

Drugdu.com expert’s response: Ⅰ. FDA Small Business Application Guide Understanding the Definition and Benefits of FDA Small Business Definition of Small Business: A small business is defined as an applicant and its affiliates whose total gross annual sales or receipts for the most recent fiscal year do not exceed 100million(notlimitedtoU.S.businesses).Ifthetotalgrossannualsalesorreceiptsofasmallbusiness/affiliatedcompanydonotexceed30 million, it is eligible for a fee waiver for Premarket Approval (PMA) applications. Benefits: The FDA offers fee reductions for small businesses. For example, the small business fee for a 510(k) submission is 25% of the standard fee, which can save up to over $16,000 (the exact amount may vary by year). Preparing the Small Business Certification Application Application Form: The dedicated FDA application form (Form FDA 3602A MDUFA Foreign Small Business Certification Request) should be completed. The form should be opened using the latest version of Adobe Pro, and not domestic software such as WPS. Ⅱ. Application Process: Starting from ...
- Source: drugdu
- 191
- December 16, 2024
【EXPERT Q&A】How to select the boundary value of reference interval of in vitro diagnostic reagent product?

Drugdu.com expert’s response: The selection of threshold values for reference intervals of in vitro diagnostic reagent products is a crucial step, directly impacting the accuracy and reliability of diagnostic results. Here is a reference guide for selection methods based on the following responses: Ⅰ. Basic Principles for Selecting Threshold Values of Reference Intervals Depending on the clinical significance, in vitro diagnostic reagents typically use either bilateral or unilateral threshold values to determine reference intervals. Bilateral threshold values usually select the population distribution range of 2.5% to 97.5%, meaning that 95% of the normal population’s test values will fall within this range. For unilateral threshold values, 95% or 5% can be chosen, depending on the clinical needs and significance of the test item. Ⅱ. Specific Methods for Selecting Threshold Values of Reference Intervals Determining the Clinical Significance of the Test Item: Firstly, it is necessary to clarify the clinical significance of ...
- Source: drugdu
- 148
- December 13, 2024
【EXPERT Q&A】Do I need to obtain authorization for the same type of medical device information?

Drugdu.com expert’s response: During the medical device registration or filing process, if the proposed referenced data for the same kind of medical device (including technical documents, clinical trial data, market usage information, etc.) are non-public, meaning these data have not been released through public channels and are protected by intellectual property rights (such as patents, trade secrets, etc.), authorization or permission from the original data holder is typically required to ensure the legitimacy and compliance of the data. This is because unauthorized use of non-public data may infringe upon the intellectual property rights of the original data holder, leading to legal disputes and regulatory risks. Therefore, when submitting a medical device registration or filing application, corresponding authorization documents or certificates should be attached to prove that the data used were legally obtained. However, if the data for the same kind of medical device are publicly published data, such as those ...
- Source: drugdu
- 144
- December 11, 2024
【EXPERT Q&A】Does ornidazole sodium chloride injection stimulate blood vessels?

Drugdu.com expert’s response: The stimulatory effect of ornidazole and sodium chloride injection on blood vessels is relatively mild, but it may still have some impact on blood vessels in certain circumstances. In clinical practice, to minimize the potential irritation to blood vessels, it is generally recommended to control the infusion rate of ornidazole and sodium chloride injection. For example, for a 100ml injection, the infusion time should typically not be less than 30 minutes. If the infusion rate is too fast, it may cause painful or tingling sensations due to blood vessel irritation. Apart from direct irritation to blood vessels, ornidazole and sodium chloride injection may also cause other adverse reactions. These reactions may involve the digestive system (such as nausea, vomiting, abdominal pain, diarrhea, and other gastrointestinal discomforts), the nervous system (such as dizziness, headache, convulsions, drowsiness, confusion, and other symptoms), the blood system (such as decreases in white ...
- Source: drugdu
- 183
- December 9, 2024
【EXPERT Q&A】What is the development trend of the medical device industry?

Drugdu.com expert’s response: The development trend of the medical device industry demonstrates diversification and a positive upward trajectory. Ⅰ. Continuous Growth in Market Size In recent years, the market size of the global and Chinese medical device industries has maintained a rapid growth trend. The market size of China’s medical device industry has grown from 623.5 billion yuan in 2019 to 1,035.8 billion yuan in 2023, with a significant annual compound growth rate. It is projected that the market size will further expand in 2024. Especially in the submarket of medical instruments, it同样 exhibits a rapid growth trend, and it is estimated that the market size of China’s medical instruments will reach 415 billion yuan by 2024. Ⅱ. Accelerated Advancement Towards High-End Products Guided by high-quality development policies, China’s medical device industry is accelerating its move towards high-end products. Innovative medical device products are emerging continuously, such as biomaterial devices, ...
- Source: drugdu
- 184
- December 6, 2024
【EXPERT Q&A】What is the process of registering Pakistan DRAP certificate?

Drugdu.com expert’s response: The process of registering for a DRAP (Drug Regulatory Authority of Pakistan) certificate involves multiple steps. Below is a detailed outline of the registration process: Ⅰ. Preliminary Preparations Understanding Regulations: Familiarize yourself with the relevant regulations and guidelines of the Pakistani medical device regulatory authority, DRAP. Understand the classification of medical devices, registration requirements, technical standards, etc. Determining Classification: Based on Pakistan’s medical device classification system, determine which category the medical device to be registered falls into. Registration requirements may vary for different categories of medical devices. Establishing Systems: Ensure that the production process and quality control of medical devices comply with international quality management standards, such as ISO 13485. This will help improve the success rate of registration and market competitiveness. Ⅱ. Preparing Application Materials Product Technical Documents: Including product specifications, technical specifications, performance indicators, etc. Quality Management System Documents: Such as ISO 13485 certificates, proving ...
- Source: drugdu
- 127
- December 4, 2024
【EXPERT Q&A】Medical device risk estimation, risk assessment, risk rating, what is it, what is the difference?

Drugdu.com expert’s response: In the field of medical devices, risk estimation, risk assessment, and risk rating are crucial steps in risk management, each with its own clear definition and distinction. Ⅰ. Definitions 1. Risk Estimation （1）Definition: The process of assigning values to the probability of occurrence and severity of harm. （2）Content: This typically involves analyzing factors such as the design, manufacturing process, and usage environment of medical devices to identify potential risk points. The purpose of risk estimation is to identify potential risks and provide a foundation for subsequent risk assessment. 2. Risk Assessment （1）Definition: The process of comparing “estimated risks” with “given risk criteria” to determine the acceptability of risks. （2）Content: Risk assessment is a more in-depth and systematic process that involves detailed analysis of identified risks, including the likelihood, severity, and effectiveness of risk control measures. The purpose of risk assessment is to determine the priority of risks ...
- Source: drugdu
- 162
- December 2, 2024
【EXPERT Q&A】What is the difference between a handheld nebulizer and a humidifier for medical devices?

Drugdu.com expert’s response: The handheld nebulizer used in medical devices differs significantly from a humidifier in multiple aspects, as detailed below: Ⅰ. Primary Functions and Purposes Handheld nebulizer: Primarily used for treating respiratory diseases such as asthma and bronchitis. It atomizes medication into tiny particles, allowing patients to inhale them directly into the respiratory tract for therapeutic effect. This device typically requires use under medical guidance and in conjunction with specific medications or solutions. Humidifier: Primarily functions to increase the humidity of indoor air, reducing discomfort caused by dryness. It generally uses purified water or filtered water and does not involve the atomization of medication. Humidifiers are widely used in homes, offices, and other settings to improve the indoor environment. Ⅱ. Atomized Particle Size Handheld nebulizer: Produces very small atomized particles, usually around 0.4 to 1 micrometer in size. This particle size makes the medication easier for the human body ...
- Source: drugdu
- 105
- November 29, 2024
【EXPERT Q&A】How does the medical device industry develop new channels and new markets under the normalization of collective mining?

Drugdu.com expert’s response: In the context of normalized centralized procurement, the medical device industry faces a new market environment and competitive landscape. To explore new channels and markets, enterprises can proceed from the following aspects: Ⅰ. Optimize Resource Allocation to Enhance Product Competitiveness Focus on Innovative Research and Development: Medical device enterprises should increase investment in innovative research and development to launch products with differentiated competitive advantages, thereby avoiding the risks associated with centralized procurement of homogeneous products. Through innovation, enterprises can open up new market segments, meet the needs of specific patients, and thus obtain higher market shares and profit margins. Diversify Product Lines: Expand the industry chain and enhance risk resistance capabilities with a multi-product portfolio. Enterprises can achieve seamless integration of the industry chain by acquiring upstream and downstream related enterprises, thereby enhancing product competitiveness and creating a synergistic effect. Ⅱ. Leverage Centralized Procurement Platforms to Expand Sales ...
- Source: drugdu
- 167
- November 27, 2024
【EXPERT Q&A】What is the difference between CE certification and FDA certification?

Drugdu.com expert’s response: Here is a detailed comparison between CE certification and FDA certification in multiple aspects, translated into English: Ⅰ. Issuing Authority and Definition CE Certification: Issued by the European Union, CE certification represents the safety certification of products in the European Union. It signifies that the product complies with the health, safety, and environmental protection regulations within the European Economic Area (EEA), serving as a “passport” for products to enter the EU market. FDA Certification: Issued by the Food and Drug Administration (FDA) of the United States, FDA certification is the regulatory agency of the US government for products related to human health and safety, including food, drugs, cosmetics, and medical devices. FDA certification is internationally recognized as one of the highest levels of safety certification and is a necessary condition for enterprises to enter the US market and some other countries with their products. Ⅱ. Scope of ...
- Source: drugdu
- 121
- November 25, 2024

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