Expert Q&A – Page 11 – media

【EXPERT Q&A】What documents are needed and what is the specific process for exporting medical equipment?

Drugdu.com expert’s response: Exporting medical equipment requires a thorough understanding of the regulatory requirements of both the exporting and importing countries, and involves several steps and essential documents: 1.Regulatory Compliance Compliance with Exporting Country Regulations: Ensure the medical equipment meets the regulatory standards of the country of origin. Compliance with Importing Country Regulations: Understand and comply with the medical device regulations of the destination country, which may include certifications like CE Marking (for Europe) or FDA approval (for the United States). 2.Essential Documents Export License: Depending on the type of equipment and the destination, an export license may be required. Commercial Invoice: Details the transaction between the exporter and importer. Packing List: Describes the contents and packaging details of the shipment. Bill of Lading or Airway Bill: Used for the shipment of goods. Certificate of Origin: States where the equipment was manufactured. Product Certifications: Documents like CE Certificate or FDA ...
- Source: drugdu
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- December 22, 2023
【EXPERT Q&A】How should one start a business in pharmaceutical intermediates?

Drugdu.com expert’s response: Entering the business of pharmaceutical intermediates involves several key steps and considerations: 1.Industry Understanding Comprehensive Research: Understand the pharmaceutical industry, focusing on the role and demand for intermediates in drug production. Market Trends and Needs: Identify current trends, future projections, and specific needs within the market for pharmaceutical intermediates. 2.Regulatory Compliance Regulatory Knowledge: Familiarize yourself with the regulatory environment, including quality standards and certifications like Good Manufacturing Practice (GMP). Licensing and Permits: Obtain necessary licenses and permits required for manufacturing and trading pharmaceutical intermediates. 3.Business Plan and Strategy Business Model Development: Develop a clear business model, including target market, business scale (local, national, international), and value proposition. Financial Planning: Prepare a detailed financial plan covering startup costs, operational expenses, and revenue projections. 4.Supply Chain and Manufacturing Manufacturing Setup: Decide whether to manufacture in-house or outsource. If manufacturing, ensure the setup meets industry standards. Supplier and Customer ...
- Source: drugdu
- 177
- December 18, 2023
【EXPERT Q&A】What is a pharmaceutical intermediate?

Drugdu.com expert’s response: A pharmaceutical intermediate is a substance that is produced during the synthesis of an active pharmaceutical ingredient (API) and is used in the further production of the API. These intermediates are crucial compounds in the drug manufacturing process, acting as pivotal building blocks that are transformed through various chemical reactions to form the final active ingredient. Pharmaceutical intermediates can vary widely in their complexity and are often produced in controlled conditions to ensure purity and quality. These intermediates are integral to the pharmaceutical industry, allowing for the efficient and cost-effective production of APIs. They play a significant role in the development of new drugs and formulations, providing flexibility and innovation in drug synthesis and design. The quality and control of pharmaceutical intermediates are vital, as they directly affect the efficacy, safety, and stability of the final pharmaceutical products. Manufacturers of pharmaceutical intermediates must adhere to strict regulatory ...
- Source: drugdu
- 262
- December 15, 2023
intermediate
【EXPERT Q&A】What are the differences between the MDR and IVDR regulations?

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 ...
- Source: drugdu
- 195
- December 4, 2023
【EXPERT Q&A】What are the processes involved in exporting pharmaceuticals to Japan?

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 ...
- Source: drugdu
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- December 1, 2023
【EXPERT Q&A】As a medical trade professional, how can one effectively manage a B2B platform account?

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 ...
- Source: drugdu
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- November 8, 2023
【Expert Q&A】How do I get started in the pharmaceutical intermediates business?

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 ...
- Source: drugdu
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- September 7, 2023
Licensing and Compliance market research pharmaceutical intermediates
【EXPERT Q&A】What are the regulations and requirements for exporting medical devices to the European Union?

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 ...
- Source: drugdu
- 320
- September 5, 2023
European Union medical device regulations
【EXPERT Q&A】What is the procedure for registering medical devices for the Russian market?

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. ...
- Source: drugdu
- 337
- August 22, 2023
medical device Russia market
【EXPERT Q&A】For pharmaceutical exports to the United States, after obtaining FDA certification, is there still a need for an import permit from the U.S.?

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.
- Source: drugdu
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- August 17, 2023
FDA approval import permit

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