Expert Q&A – media

【EXPERT Q&A】What is the difference between the European Drug Master File (EDMF) and the US DMF?

Drugdu.com expert’s response: The European Drug Master File (EDMF) and the United States Drug Master File (DMF) both comprehensively represent aspects of pharmaceutical production and quality, but due to their targeting of different markets, there are certain differences between them. Below is a detailed comparison of the two: Ⅰ. Structure and Content EDMF: Consists of four parts: EDMF Public Part, Confidential Part, Quality Overview Summary (QOS) Public Part, and QOS Confidential Part. The contents of these four parts overlap, but for the same content, the degree of description differs among the parts. For example, all four parts contain process descriptions, but only the Confidential Part includes the complete process, while the others only provide a brief overview of the process. DMF: Comprises a single, comprehensive document without the clear sub-division seen in the EDMF. The content is relatively concentrated, covering detailed information on pharmaceutical production, quality, and other aspects. Ⅱ. Quality Reference ...
- Source: drugdu
- 176
- January 3, 2025
【EXPERT Q&A】What qualifications do you need to export Class II medical devices to Japan?

Drugdu.com expert’s response: Exporting Class II Medical Devices to Japan requires compliance with Japan’s Pharmaceutical and Medical Device Act (PMD Act). Here are the primary qualifications and steps required: Determining Product Classification and JMDN Code: According to the PMD Act, medical devices are classified into I, II Special Control, II Controlled, III, and IV categories. It is necessary to determine the specific classification and JMDN code for the exported Class II medical devices. Manufacturer Registration: Foreign manufacturers must register their manufacturer information with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), including details on product design, production, and key processes. QMS Factory Audit: For Class II Special Control products, an application for a Quality Management System (QMS) factory audit must be submitted to the authorized certification body, PCB. For other Class II products, as well as Class III and IV products, an application for a QMS factory audit must be submitted ...
- Source: drugdu
- 65
- January 1, 2025
【EXPERT Q&A】What is the meaning of the red list, yellow list and green list involved in FDA import alerts?

Drugdu.com expert’s response: The import alert system of the FDA (Food and Drug Administration) is a crucial means for it to ensure the safety of imported products, particularly foods, drugs, cosmetics, medical devices, and more. Among them, the red list, yellow list, and green list are ways used by the FDA to indicate the compliance status of different categories of products. Below are their specific meanings in English: Ⅰ. Red List Definition: The red list represents the strictest warning, indicating that the product or manufacturer has serious compliance issues, often due to the product failing FDA inspections or tests. Characteristics: Once a product is placed on the red list, it will face automatic detention until the manufacturer, shipper, grower, or importer proves to the FDA that the violations have been corrected. This detention occurs without the need for FDA to inspect, examine, or sample the product, also known as “Detention ...
- Source: drugdu
- 61
- December 30, 2024
【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
- 55
- 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
- 119
- 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
- 60
- 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
- 85
- 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
- 90
- 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
- 87
- 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
- 80
- December 13, 2024

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.