Expert Q&A – Page 6 – media

【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
- 115
- 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
- 86
- 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
- 104
- 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
- 89
- 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
- 81
- 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
- 82
- September 13, 2024
【EXPERT Q&A】Which countries’ certificates can be converted after CB certification?

Drugdu.com expert’s response: After obtaining CB certification, manufacturers can convert it into certification for multiple countries. The CB Scheme is based on International Electrotechnical Commission (IEC) standards, through which manufacturers can use a CB Test Certificate issued by a National Certification Body (NCB) to obtain national certifications from other member countries of the CB Scheme. Here are some of the national certifications that can be converted from CB certification: Ⅰ. Countries Where CB Certification Can Be Converted Europe: Germany (VDE, GS, etc.) / France / United Kingdom / Netherlands / Spain / Italy / Austria / Sweden / Switzerland, etc. Americas: United States (UL, ETL, etc.) / Canada (CSA, ULC, etc.) / Mexico / Brazil. Asia-Pacific: Australia (RCM, SAA, etc.) / New Zealand / Japan / South Korea (KC Mark) / Singapore / India / Thailand. Other Regions: South Africa / Turkey / Russia / Ukraine / Argentina / Brazil (Note: Listed twice as Brazil is mentioned in both Americas and Other ...
- Source: drugdu
- 91
- September 11, 2024
【EXPERT Q&A】Why domestic medical device bidding needs CE certification?

Drugdu.com expert’s response: The reasons for requiring CE certification in domestic medical device tenders can be elaborated from multiple perspectives: Ⅰ. International Recognition and Market Access of CE Certification International Recognition: CE certification is a prerequisite for market access in Europe. Medical devices with CE certification must comply with European standards such as EN60601 and EN45545. This signifies that CE certification not only enjoys a high level of recognition in the European market but is also globally recognized as an important indicator of product quality and safety. Market Access: For medical device manufacturers aiming to enter the European market, CE certification is indispensable. Without the CE mark, it is illegal to sell or distribute medical devices within the European Economic Area. Therefore, requiring CE certification for domestic medical devices in tenders helps enhance their competitiveness in international markets. Ⅱ. Enhancing Product Quality and Safety Quality Improvement: To obtain CE certification, ...
- Source: drugdu
- 74
- September 9, 2024
【EXPERT Q&A】What are the six bases for the classification of import and export commodities?

Drugdu.com expert’s response: The six major bases for the classification of import and export commodities mainly include the following aspects: Ⅰ. The Harmonized System Convention on Commodity Nomenclature and Coding (HS Convention) Commodity Classification System: The classification of import and export commodities is first and foremost conducted under the commodity classification system of the Harmonized System Convention (abbreviated as HS Convention). This is an internationally recognized standard for commodity classification, used for coding and categorizing commodities in global trade. Ⅱ. Customs Tariff of the People’s Republic of China: The Customs Tariff serves as the fundamental document for China’s customs authorities to classify and levy taxes on import and export commodities. It provides detailed listings of tariff numbers and rates for various commodities, serving as a crucial basis for determining the coding and tariff rates of import and export commodities. Ⅲ. Explanatory Notes to the Customs Tariff of the People’s Republic ...
- Source: drugdu
- 87
- September 6, 2024
【EXPERT Q&A】Where to check pharmacovigilance data?

Drugdu.com expert’s response: Regarding the inquiry of pharmacovigilance data, you can access the following specific agencies: Ⅰ. National Medical Products Administration (NMPA) and Its Subsidiaries NMPA Official Website: Each year, the NMPA releases the “Annual Report on National Adverse Drug Reaction Monitoring,” which informs the public of the annual status of adverse drug reaction monitoring in China. These reports and related pharmacovigilance information can be found on the NMPA’s official website (nmpa.gov.cn). National Center for Adverse Drug Reaction Monitoring (NCADR): The NCADR regularly compiles and publishes domestic pharmacovigilance information, as well as international pharmacovigilance alerts. This information can also be accessed on the NMPA’s official website or the NCADR’s official website (cdr-adr.org.cn). Ⅱ. Local Governments and Agencies Some local governments or drug regulatory agencies may have established their own pharmacovigilance databases or information platforms. For instance, Shandong Province has the “Medication ‘Alert’ Platform,” which utilizes information technology to provide channels ...
- Source: drugdu
- 97
- September 5, 2024

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