Expert Q&A – media

【EXPERT Q&A】What are the content requirements of the medical device Post-marketing Supervision Plan (PMS Plan) required by the EU CE?

Drugdu.com expert’s response: The Post-Market Surveillance (PMS) Plan for medical devices required by the EU CE is a comprehensive strategic document aimed at ensuring the continued safety, effectiveness, and compliance of medical devices after they have been released to the market. The core content of this plan revolves around the following aspects, aiming to establish a comprehensive and responsive surveillance system: Firstly, defining objectives and scope. The PMS Plan must clearly outline its objectives, which are to ensure the safety and effectiveness of medical devices during use while minimizing potential risks. It should encompass all key stakeholders, including manufacturers, distributors, users, and regulatory authorities, and be applicable to various types of medical devices, both for home use and professional purposes. Secondly, establishing a data collection and analysis mechanism. The plan requires the creation of an efficient data collection system to capture information from multiple sources, such as sales data, user ...
- Source: drugdu
- 36
- December 20, 2024
【EXPERT Q&A】Can imported medical devices be commissioned to domestic third party production?

Drugdu.com expert’s response: The direct commissioning of domestic third-party production for imported medical devices is not permitted. This regulation is primarily based on the stringent quality control and regulatory requirements for medical device production. Due to the differences in medical device regulatory systems across different countries and regions, directly commissioning domestic third-party production may pose risks in terms of quality and regulation. However, the registrant of imported medical devices can produce Class II and Class III medical devices that have already obtained imported medical device registration certificates within China through a foreign-invested enterprise established within the territory. This approach requires meeting certain conditions, such as no changes to the product design and maintaining a consistent quality system, to ensure that there are no significant changes to the safety and effectiveness of the products. Additionally, the original imported registration certificate must be valid; if it has expired or been cancelled, it ...
- Source: drugdu
- 68
- December 18, 2024
【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
- 67
- 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
- 69
- 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
- 74
- 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
- 77
- 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
- 85
- 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
- 57
- 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
- 91
- 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
- 73
- November 29, 2024

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