Expert Q&A – Page 3 – media

【EXPERT Q&A】What documents are needed for drug import declaration? Why?

Drugdu.com expert’s response: The requirements for documents in drug import customs clearance are complex and comprehensive, aiming to ensure the quality, safety, and legality of imported drugs in compliance with China’s drug administration regulations. Ⅰ. Key Documents Import Drug Registration Certificate (or Pharmaceutical Product Registration Certificate) Reason: Verifies that the drug has been registered in China and approved by relevant national departments, allowing for legal sale and use domestically. Drug Business License or Drug Production License and Enterprise Legal Person Business License Reason: Demonstrates that the enterprise importing drugs possesses the legal qualifications for drug operation or production, as well as the legitimacy and scope of business. Certificate of Origin Reason: Proves the origin of the imported drugs, serving as an important basis for customs import administration and tariff collection. Purchase Contract Reason: Verifies the authenticity and legality of the transaction for imported drugs, including information on buyer and seller, transaction quantity, price, etc. Packing List, ...
- Source: drugdu
- 84
- October 4, 2024
【EXPERT Q&A】What is the role, definition, and inquiry of the FDA Consensus Standard for medical devices?

Drugdu.com expert’s response: FDA medical device consensus standards play a pivotal role in the medical device industry. Ⅰ. The Role of FDA Medical Device Consensus Standards Ensuring Safety and Effectiveness: These standards assist manufacturers in ensuring that their medical devices meet safety and effectiveness requirements during design, manufacturing, and usage, thereby safeguarding the health of patients and users. Streamlining Regulatory Processes: Manufacturers can leverage these consensus standards to fulfill FDA regulatory requirements, reducing the need for redundant testing and evaluations, which accelerates pre-market approval timelines. Enhancing Transparency: Consensus standards provide clear benchmarks for medical device performance and safety, contributing to increased industry transparency and fostering fair competition. Facilitating International Harmonization: Many FDA-recognized medical device consensus standards are international, simplifying international trade and market access, thereby promoting coordinated development of the global medical device market. Ⅱ. Definition of FDA Medical Device Consensus Standards FDA medical device consensus standards refer to a ...
- Source: drugdu
- 78
- October 2, 2024
【EXPERT Q&A】What is the latest development of FIC drugs?

Drugdu.com expert’s response: FIC (First-in-class) drugs, as their name implies, are the first medications of their kind with entirely novel and unique mechanisms of action, pioneering the treatment of specific diseases. Their latest advancements can be outlined from several perspectives: Ⅰ. Overview of FIC Drugs Globally and in China Global Scope: According to publicly available information, the FDA approved a total of 55 new drugs in 2023, among which 20 were FIC drugs, accounting for 36% of the total. This underscores the pivotal role of FIC drugs in the global drug discovery and development landscape. Chinese Scope: Chinese enterprises are increasingly focusing on innovative drugs. In 2023, 30 of the newly approved drugs in China were developed domestically, constituting 37% of the overall approvals. Furthermore, Chinese scholars’ publications in authoritative journals indicate a significant increase in the total number of innovative products in China’s pipeline, with FIC products growing from ...
- Source: drugdu
- 79
- September 30, 2024
【EXPERT Q&A】What is the difference between medical devices and non-medical devices?

Drugdu.com expert’s response: The differences between medical devices and non-medical devices are primarily manifested in the following six aspects: Ⅰ. Definition and Purpose Medical Devices: Refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials, and other similar or related articles, including the necessary computer software, that are directly or indirectly used on the human body. Their efficacy is primarily obtained through physical means rather than through pharmacology, immunology, or metabolism, or if these means are involved, they only play an auxiliary role. The primary purposes include diagnosis, prevention, monitoring, treatment, or alleviation of diseases, as well as diagnosis, monitoring, treatment, alleviation, or functional compensation of injuries. Non-Medical Devices: Generally refer to products that are not directly used on the human body or, even if in contact with the human body, do not have a medical purpose. They may be daily necessities, industrial products, consumer goods, such as ...
- Source: drugdu
- 77
- September 27, 2024
【EXPERT Q&A】What is the process of exporting drugs to Mexico?

Drugdu.com expert’s response: The process of exporting pharmaceuticals to Mexico involves multiple stages, which can be outlined in detail as follows: I. Pre-Export Preparation （1）Understanding Regulations and Policies: Conduct thorough research on Mexican laws and regulations pertaining to pharmaceutical imports, including import permit requirements, quality standards, prohibited and restricted medicinal ingredients. Verify the legality of the drugs in Mexico and assess market demand. （2）Selecting Partners: Identify logistics companies with expertise in pharmaceutical exports to Mexico, ensuring they possess the necessary qualifications and capabilities. Communicate with the logistics partner to clarify responsibilities and benefits, finalizing a cooperation agreement. （3）Preparing Necessary Documentation: Assemble essential export documents such as export permits, inspection reports, and certificates of origin. Prepare Mexican-required import documents, including import permits, health certificates, and others. II. Pharmaceutical Preparation and Packaging （1）Pharmaceutical Preparation: Ensure drug quality adheres to Mexican import standards. Prepare related materials like drug formulas, instructions, and production batch ...
- Source: drugdu
- 93
- September 25, 2024
【EXPERT Q&A】Why should medical device companies make full use of data value under the normalization of collection?

Drugdu.com expert’s response: In the context of normalized centralized procurement, the importance of medical device enterprises leveraging data value has become increasingly prominent. This primarily stems from the following considerations: Ⅰ. Market Trend Insight and Precise Positioning Market Analysis Reports: CRM systems or other data analytics tools can provide detailed market analysis reports, enabling enterprises to promptly understand market size, competitive landscape, and trend changes. This aids enterprises in precisely positioning themselves in the market under centralized procurement policies, adjusting product portfolios and marketing strategies to better align with market demands. Competitive Landscape Analysis: Through data analysis, enterprises can grasp competitors’ dynamics, including their product layouts, market shares, pricing strategies, etc., thereby formulating more targeted competitive strategies. Ⅱ. Customer Demand Response and Satisfaction Enhancement Customer Analysis Reports: Enterprises can gain deep insights into customer preferences, purchasing behaviors, and satisfaction levels, providing data support for product design, customized services, and after-sales ...
- Source: drugdu
- 76
- September 23, 2024
【EXPERT Q&A】What are the roles of cnas certification?

Drugdu.com expert’s response: The role of CNAS (China National Accreditation Service for Conformity Assessment) certification is primarily manifested in the following six aspects: Ⅰ. Recognition of Technical Capabilities and Management Levels Technical Capability Verification: CNAS certification demonstrates that an organization possesses the technical capability to conduct testing and calibration services in accordance with the corresponding accreditation criteria. This serves as an authoritative recognition of the organization’s technical strength. Management System Establishment: By obtaining CNAS certification, organizations are required to establish quality management systems that comply with international standards, thereby comprehensively enhancing their quality management levels and ensuring the stability and reliability of their products or services. Ⅱ. Enhancing Market Competitiveness and Social Trust Boosting Competitiveness: Attaining CNAS certification can strengthen an organization’s competitiveness in both domestic and international markets, earning their trust from government departments and various sectors of society. For third-party software testing enterprises, CNAS certification is a manifestation ...
- Source: drugdu
- 76
- September 20, 2024
【EXPERT Q&A】Do Mexican apis need to be registered separately or in conjunction with preparations?

Drugdu.com expert’s response: The registration requirements for Active Pharmaceutical Ingredients (APIs) in Mexico typically involve a separate registration process, rather than simply being associated with the registration of the final dosage form. This is because APIs, as the essential components of dosage forms, have a direct impact on the quality, safety, and efficacy of the final product. Registration Requirements for APIs in Mexico Approval from the Mexican Ministry of Health: The export of APIs to Mexico requires approval from the Mexican Ministry of Health. This signifies that APIs must comply with Mexico’s local pharmaceutical regulations and standards. COFEPRIS Registration: Manufacturers of APIs need to register with the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), which is the primary agency under the Mexican Ministry of Health responsible for regulating drugs, medical devices, cosmetics, and hygiene products. During the registration process, companies must submit a range of documents, including but not limited ...
- Source: drugdu
- 65
- September 18, 2024
【EXPERT Q&A】How to prepare for AEO certification?

Drugdu.com expert’s response: AEO certification (Authorized Economic Operator) is a system implemented by customs authorities to certify enterprises with good credit standing, compliance, and security management, granting them customs clearance facilitation. Before embarking on the AEO certification process, enterprises need to prepare thoroughly as follows: Ⅰ. Understanding AEO Certification Standards and Requirements Familiarize with Certification Standards: Enterprises should thoroughly read and comprehend the “Customs High-Level Certified Enterprise Standards,” which encompass general standards and specific standards tailored to different types of enterprises, such as importers/exporters of goods and customs brokers. Clarify Application Conditions: Ensure that the enterprise meets the basic conditions for AEO certification, including registration and filing, sound financial status, and lawful operations. Ⅱ. Internal Preparation Comprehensive Review and Self-Assessment: Conduct a comprehensive review of the enterprise’s production and operation, import and export activities, financial data, etc., ensuring their authenticity, accuracy, and completeness. Examine whether the enterprise’s internal control system, ...
- Source: drugdu
- 67
- September 16, 2024
【EXPERT Q&A】What certification is required for medical device export clearance to the United States?

Drugdu.com expert’s response: Exporting medical devices to the United States for customs clearance involves fulfilling a series of certifications and requirements, primarily encompassing the following aspects: Ⅰ. FDA Registration and Certification FDA Registration: Manufacturers or exporters need to register with the Food and Drug Administration (FDA) in the United States to legally sell medical devices in the American market. This process is typically completed through FDA’s Electronic Registration System (FURLS). 510(k) Premarket Notification: For medical devices classified as “Class II” (Premarket Notification), a 510(k) submission is generally required. This application demonstrates that the device is technologically similar to a legally marketed device and meets FDA requirements. The review period typically takes 90 days. PMA Application: For high-risk medical devices classified as “Class III” (Premarket Approval), a PMA (Premarket Approval Application) may be necessary. This is a more rigorous application requiring substantial clinical data and evidence to prove the safety and ...
- Source: drugdu
- 67
- September 13, 2024

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