Drugdu.com expert’s response: Although the MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) share a common purpose, they apply to different categories of products, with specific differences in the following aspects: Scope of Application: MDR is a regulation for medical devices: It applies to all medical devices not used for in vitro diagnostics, including surgical tools, medical equipment, implants, etc. IVDR is a regulation for in vitro diagnostic medical devices: It specifically applies to in vitro diagnostic devices, such as reagent kits and equipment used for blood analysis. Classification System: MDR: Implements a new risk-based classification system, detailing medical devices into different levels more comprehensively. IVDR: Introduces a new risk classification rule, which is a significant change for the in vitro diagnostic device industry, especially increasing the scrutiny requirements for high-risk IVD products. Clinical Requirements: MDR: Strengthens the requirements for clinical evidence, demanding manufacturers to conduct clinical assessments and ...
Drugdu.com expert’s response: Exporting pharmaceuticals to Japan involves a complex process with multiple steps, due to the stringent regulatory system of the Japanese pharmaceutical market. Here are the key steps summarized by Dide Medical Trade Network: 1.Understanding Japanese Pharmaceutical Market Regulations Before starting the export process, it is crucial to have an in-depth understanding of Japan’s pharmaceutical regulatory laws. The Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) are the main regulatory bodies responsible for the approval and supervision of pharmaceuticals. 2.Product Registration and Approval All pharmaceuticals intended for sale in the Japanese market must be registered and approved by the MHLW. This usually involves submitting detailed information about the pharmaceutical, such as clinical trial data, evidence of safety and efficacy, etc. 3.Japanese GMP Certification Japan has strict quality control standards for pharmaceutical production, and pharmaceuticals exported to Japan must be produced in ...
Drugdu.com expert’s response: As a medical trade professional, effectively operating a B2B platform account is key to achieving good promotional results. Here are some suggestions to help you better manage and promote your B2B account: 1.Complete and professional company profile: Ensure your company profile (including company introduction, contact details, licenses, qualifications, etc.) is complete and up-to-date. High-quality images and clear product descriptions will enhance the appeal of your company and products. 2.Continuous product updates: Regularly update your product catalog, ensuring each product description is accurate and detailed. Provide key information such as product images, specifications, prices, and MOQ (Minimum Order Quantity). 3.Timely responses: For B2B buyers, a quick and professional response is crucial. Ensure you or your team can reply to buyer inquiries promptly. 4.Customer reviews and feedback: Encourage satisfied customers to provide positive feedback, which can increase trust from other potential buyers. For any negative feedback, respond promptly and attempt ...
Entering the pharmaceutical intermediates business is a challenge that requires a wide range of specialized knowledge and experience, especially if you don’t have an extensive network in this field. Here are some suggestions to help you get started and succeed in your business: I. Basic Preparation Market Research: Understand industry trends, target customers, competitors, and market demand. Financing and Budget: Ensure you have enough capital to operate, including for production, sales, and marketing. Licensing and Compliance: Know and adhere to all relevant laws and regulations, including obtaining necessary permits and certifications. II. Technology and Production R&D Capability: Have or partner with reliable R&D institutions to develop and improve products. Quality Control: Establish strict quality control procedures. Supply Chain Management: Find reliable raw material suppliers and establish robust logistics and inventory management systems. III. Sales and Marketing Sales Team: Establish or hire an experienced sales team. Online Marketing: Utilize websites, social ...
Drugdu.com expert’s response: Entering the European Union market requires medical device products to adhere to a series of stringent regulations and quality standards. Firstly, products must obtain CE certification, a mark that signifies compliance with EU requirements for safety, health, and environmental protection. Before submitting an application, make sure that all relevant application forms are completed in detail, including key data such as product specifications and manufacturer information. Upon passing preliminary review, the product will be sent to an EU-designated third-party certification body for comprehensive and accurate testing and evaluation. This body will assess the product’s compliance with the EU Medical Device Directive (MDD) or Medical Device Regulation (MDR), depending on the case. After successfully completing the certification process, you will receive EU export product certification, an indispensable credential proving that your product can be legally sold in the EU market. It should be noted that due to the wide variety ...
Drugdu.com expert’s response: The registration process in Russia mainly consists of the following steps: Submission of Application: First, you need to submit a registration application to the Russian Ministry of Health. This typically includes detailed information about your product such as the name, type, specifications, manufacturer information, etc. Technical Documentation Review: The Russian Ministry of Health will review the technical documentation you have submitted. This might encompass details of your product design, production process, quality control systems, etc. Clinical Evaluation: You might be required to undergo a clinical evaluation to demonstrate the safety and efficacy of your product. This could involve clinical trials or submission of other forms of clinical data. Manufacturer Review: The Russian Ministry of Health might review the manufacturer to ensure compliance with Russian laws and regulations. Obtaining the Registration Certificate: If your product passes the above steps of the review, you will receive a registration certificate. ...
Drugdu.com expert’s response: To export pharmaceuticals to the United States, in addition to obtaining FDA certification, one must also comply with other U.S. import regulations. After receiving FDA approval, the drug also needs to adhere to the import regulations set by the U.S. Customs and Border Protection (CBP). Sometimes, this may involve obtaining additional import permits or certificates, but the specific requirements can vary based on the type of product and specific circumstances. Before shipping the drug to the U.S., ensure that you are familiar with and compliant with all relevant regulations. Collaborating with local import/export agents might be helpful as they are typically knowledgeable about these regulations and can provide specific guidance.
Drugdu.com expert’s response: The FDA drug approval process is both standardized and rigorous. Here’s a detailed breakdown of the entire process: 1.Preclinical Research: This is the first step in the drug approval process. It includes pharmacological and toxicological studies to evaluate the safety and effectiveness of the drug. These studies are usually conducted in laboratories or on animal models. 2.Submission of Investigational New Drug (IND) Application: Once the data from preclinical studies suggest that the drug might be safe, the pharmaceutical company submits an Investigational New Drug (IND) application. The IND contains data from preclinical studies, manufacturing information, clinical trial protocols, and more. 3.Clinical Trials: This is the heart of the drug approval process and it typically encompasses three phases. Phase I primarily tests the drug’s safety and dosage in humans. Phase II focuses on its effectiveness and side effects. Phase III further verifies its effectiveness, monitors side effects, and compares ...
Drugdu.com expert’s response: For foreign trade salespeople, every inquiry received is hard-won and should be treasured. However, inevitably among these inquiries, there will be phishing emails, junk inquiries, and even more seriously, potential scammers. Therefore, upon receiving an email, the immediate response is not advisable. Instead, it’s essential first to discern and analyze. How to handle and reply to inquiries more effectively is the key to success. 1. Determine authenticity: 01 Check the IP: Check the sender’s IP by right-clicking the email, selecting properties-details to view the IP address of the email. Determine its geographical location. Also, cross-reference the IP records in the website counter to observe whether the visitor clicked a link to enter the website or typed in your URL directly. 02 Consider the sending time: Look at the email sending time and account for time zone differences. Generally, no one would send emails in the middle ...
Drugdu.com expert’s response: Promoting pharmaceutical intermediates essentially hinges on market positioning and the intended target audience. Here are some effective methods to promote pharmaceutical intermediates: 1.Participate in Professional Expos: This provides an excellent opportunity to meet potential clients and showcase your products. You can display product samples and engage in face-to-face business discussions. 2. Establish an Official Website: By setting up an official website, you can showcase your company’s capabilities, product details, and enhance your corporate image. 3. Online Marketing: For instance, post product information on industry-specific websites. Using Search Engine Optimization (SEO) and Search Engine Marketing (SEM) strategies can boost the online visibility of your products. 4. Cold-call Potential Customers: Take the initiative to reach out to companies that might be interested. This can be done via emails or phone calls. 5. Promote through Industry-specific Platforms: Drugdu.com is a dedicated platform for medical imports and exports. It caters to industry ...
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