Expert Q&A – Page 2 – media

【EXPERT Q&A】What information should be prepared for medical device export?

Drugdu.com expert’s response: Exporting medical devices requires a series of documents to ensure the legitimacy and safety of the products, as well as compliance with the relevant regulations and requirements of the importing country. Below is a detailed list of required documents: Ⅰ. Corporate Qualification Documents Business License: Certifies that the exporting enterprise has legal operating qualifications. Medical Device Operation License: If the enterprise engages in medical device operations, it must provide a Medical Device Operation License issued by the National Medical Products Administration. However, please note that for certain categories of medical devices, if their safety and effectiveness are not affected by the distribution process, they may be exempt from operation registration. Medical Device Production License: If the enterprise produces medical devices itself, it must provide this license to prove its qualification to produce medical devices. Identification Documents of the Legal Representative or Business Responsible Person: Provide copies of ...
- Source: drugdu
- 74
- December 27, 2024
【EXPERT Q&A】Do fascia guns need to be certified as medical devices in Japan?

Drugdu.com expert’s response: Whether a fascia gun needs to undergo medical device certification in Japan mainly depends on its market positioning and product category. I. Market Positioning of Fascia Guns in Japan There are two different product definitions for fascia guns in the Japanese market: Ordinary Household Products: If fascia guns are exported to Japan as ordinary household products, they are not required to undergo mandatory medical device certification and can be sold directly in the Japanese market. Medical Devices: If fascia guns are defined as medical devices and exported to Japan, they will need to undergo medical device certification. In this case, the product’s added value may increase and it may become more favored by the Japanese market. According to the regulations of the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, fascia guns classified as medical devices fall under “designated controlled” products. II. Certification Process for Medical Devices ...
- Source: drugdu
- 136
- December 25, 2024
【EXPERT Q&A】What is the development process of a qualified medical device?

Drugdu.com expert’s response: The development process of a qualified medical device typically includes the following key steps: Ⅰ. Preliminary Preparations Business Registration: Register the company and clarify the business scope to prepare for future product production ranges and avoid subsequent changes. Team Formation: Establish a professional and efficient R&D team, including talents in mechanical engineering, electrical engineering, software engineering, etc., to ensure the technical feasibility of the product. Ⅱ. Product Development and Design Product Requirement Determination: Conduct market research, clinical application scenario analysis, doctor visits, etc., by the product manager to clarify the product’s functional requirements, performance requirements, and user expectations. System Requirement Determination: Convert product requirements into engineering technical indicators, complete the division of system functional architecture and constituent components, and output related requirements for regulations and standards, risk and safety, usability, serviceability, and manufacturability. R&D and Design: Based on system requirements, carry out structural design, sampling verification, and ...
- Source: drugdu
- 67
- December 23, 2024
【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
- 94
- 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
- 98
- 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
- 103
- 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
- 89
- 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
- 94
- 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
- 101
- 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
- 98
- December 6, 2024

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