Expert Q&A – Page 21 – media

【EXPERT Q&A】What are the advantages of MDSAP medical device system certificate?

Drugdu.com expert’s response: The MDSAP (Medical Device Single Audit Program), also known as the “Medical Device Single Audit Program,” is an audit process recognized and joined by five medical device regulatory agencies from the United States FDA, Australia TGA, Brazil ANVISA, Canada HC, and Japan MHLW. This system certification brings numerous benefits and advantages to medical device manufacturers, primarily in the following aspects: I. Streamlining the Audit Process Reducing Redundant Audits: MDSAP employs a one-time audit process that encompasses the regulatory requirements of multiple countries. Manufacturers need to undergo a single audit to meet market access requirements across participating nations, eliminating the duplication of effort and time waste associated with multiple audits. Unifying Audit Standards: MDSAP certification ensures that a manufacturer’s quality management system and products align with the audit standards and requirements of the five participating countries and regions, facilitating consistency in quality and compliance and simplifying audit procedures ...
- Source: drugdu
- 261
- August 28, 2024
【EXPERT Q&A】Do I need to apply for Import License in Germany when exporting insulin apis to Germany?

Drugdu.com expert’s response: Regarding the question of whether an Import License is required for exporting insulin Active Pharmaceutical Ingredients (APIs) to Germany, I will address this from both international trade and pharmaceutical regulatory perspectives. Hopefully, this will provide you with valuable insights. Firstly, it is crucial to note that Germany, as a member of the European Union (EU), subjects the import and sale of pharmaceutical products, including APIs, to stringent regulatory frameworks. Typically, the import of pharmaceuticals (APIs included) must comply with the relevant EU and German laws and regulations. Whether an Import License is necessary for insulin APIs exported to Germany depends on several factors: I. EU and German Pharmaceutical Regulatory Policies: The EU’s pharmaceutical regulatory system may require prior import authorization or certification for certain pharmaceuticals or APIs. Therefore, it is essential to consult the latest EU and German pharmaceutical regulations to determine if insulin APIs are subject ...
- Source: drugdu
- 356
- August 26, 2024
【EXPERT Q&A】What is a passive medical device?

Drugdu.com expert’s response: Passive medical devices refer to those that do not rely on external energy sources (such as electricity or batteries) to perform their intended functions. These devices typically utilize physical principles like mechanics, optics, acoustics, and thermodynamics to achieve their functions, with their energy primarily derived from the human body itself or gravitational forces. I. Characteristics of Passive Medical Devices Energy Source: Passive medical devices do not depend on external power sources or other forms of energy. Instead, they operate directly using natural forces such as the human body or gravity. Function Realization: They achieve their intended medical functions through physical principles like mechanical force, pressure, optical properties, etc. Safety: Since they do not rely on external power, these devices generally do not generate electromagnetic interference or radiation during use, making them safer for the human body. II. Classification of Passive Medical Devices Passive medical devices can be ...
- Source: drugdu
- 322
- August 26, 2024
【EXPERT Q&A】Can veterinary drug API companies succeed in CDMO transformation?

Drugdu.com expert’s response: I agree that the success of a veterinary API (Active Pharmaceutical Ingredient) company’s transition to CDMO (Contract Development and Manufacturing Organization) hinges on both the potential for success and the crucial factors that contribute to it. Here’s a translation of your points into English: I. Potential for Successful Transition Market Demand: With the rapid development of the global pharmaceutical industry, the veterinary drug market has also shown a steady growth trend. The transition of veterinary API companies to CDMO can cater to the outsourcing needs in veterinary drug R&D and production, particularly for those lacking in-house R&D and manufacturing capabilities, making CDMO services all the more crucial. Technical Accumulation: Veterinary API companies have accumulated substantial technical experience and production capabilities through their manufacturing processes, which can be effectively leveraged during the transition to CDMO. By enhancing their R&D capabilities and service standards, these companies can offer higher-quality, ...
- Source: drugdu
- 331
- August 23, 2024
【EXPERT Q&A】What is the export procedure of proprietary Chinese medicine?

Drugdu.com expert’s response: To successfully export proprietary Chinese medicines, the following processes are required: I. Preliminary Preparations Understanding Target Market Regulations: Prior to exporting traditional Chinese medicines (TCMs), enterprises must conduct thorough research on the relevant regulations of the target market, including import registration requirements, quality standards, and certification systems. This information is crucial for ensuring the smooth entry of TCMs into the target market. Product Preparation: a. Ensure that the exported TCMs comply with relevant quality standards and possess valid drug production licenses and drug registration certificates issued by the national drug regulatory authority. b. Prepare product specifications, labels, packaging, etc., ensuring they comply with the regulatory requirements of the target market. Finding Partners: Identify suitable partners, such as importers, agents, or distributors. Selecting the right partners can help enterprises better understand the target market and reduce export risks. II. Preparation of Application Materials Basic Information of Medicines: Detailed information on the TCMs ...
- Source: drugdu
- 411
- August 20, 2024
【EXPERT Q&A】Why do import and export enterprises have to do AEO certification?

Drugdu.com expert’s response: The necessity for import-export enterprises to undergo AEO (Authorized Economic Operator) certification primarily stems from the following aspects: I. Enhancing International Competitiveness 1.High International Recognition: AEO certification, a globally recognized standard formulated by the World Customs Organization (WCO), carries international mutual recognition. Enterprises with AEO certification are regarded as secure and reliable trading partners in international trade, thereby enhancing their international credibility and reputation. 2.Priority Customs Clearance: AEO-certified enterprises enjoy preferential treatment such as priority processing and reduced inspections, including diminished time and procedures for customs inspections, border controls, and logistics security. This expedites cargo clearance, shortens the dwell time at customs, and improves both export and import efficiency. II. Reducing Costs and Improving Efficiency 1.Lower Inspection and Audit Frequencies: AEO-certified enterprises benefit from reduced inspection rates and audit frequencies during import-export activities, minimizing unnecessary inconveniences and additional expenses. This helps to lower international trade costs, encompassing ...
- Source: drugdu
- 279
- August 19, 2024
【EXPERT Q&A】

Drugdu.com expert’s response: The export of Class I medical devices to South Africa primarily requires certification from the South African Health Products Regulatory Authority (SAHPRA). Below is a detailed analysis of the certifications needed for exporting Class I medical devices to South Africa: I. ISO Certification Many medical devices may require ISO quality management system certification before being exported to South Africa, particularly ISO 13485 certification. ISO 13485 is an international standard for medical device quality management and a global quality management system certification standard specifically for medical device manufacturers. By obtaining ISO 13485 certification, manufacturers can demonstrate that their quality management systems comply with international standards, thereby enhancing the competitiveness of their products in the South African market. II. SAHPRA Certification Product Classification and Requirements: SAHPRA classifies medical devices into four categories from Class A (lowest risk) to Class D (highest risk). Class I medical devices typically refer to products ...
- Source: drugdu
- 258
- August 18, 2024
【EXPERT Q&A】Do foreign trade without import and export rights are there other ways to export?

Drugdu.com expert’s response: When foreign trade enterprises do not possess import and export rights, there are indeed alternative methods to achieve exports. These methods primarily encompass: I. Export Under Billing This refers to units without import and export rights using the name of another import and export company for export purposes. The specific operational process is as follows: 1.Purchase of Export Documents: Acquire a set of export customs declaration documents, which will be used for customs clearance procedures. 2.Submission of Customs Declaration Materials: Submit the purchased customs declaration materials to a customs broker or freight forwarder for customs clearance. Once the goods are successfully declared and released, the process of export under billing is completed. 3.Handling of Customs Clearance Documents: The information used for customs declaration may differ from the header company for customs clearance documents provided to the recipient at the destination port, but documents must be consistent, meaning ...
- Source: drugdu
- 448
- August 16, 2024
【EXPERT Q&A】How to apply for the management record of Class II medical devices?

Drugdu.com expert’s response: The application process for the Class II medical device operation registration mainly involves the following steps: Ⅰ. Prepare Registration Materials 1.Enterprise Qualification Documents: Copy of the enterprise’s business license, certifying its legal business qualifications. 2.Organization code certificate (if applicable), verifying the enterprise’s organization code. 3.dentity cards, educational background, or professional title certificates of the enterprise’s legal representative or person in charge, and quality managers, to verify the identity and qualifications of relevant personnel. 4.Quality Management Personnel and Professional Technical Personnel Information: Work resumes of quality management personnel. 5.A list of professional technical personnel, along with their identity cards, educational certificates, and professional title certificates, to demonstrate the enterprise’s quality management capabilities and professional technical proficiency. 6.Business Premises and Warehouse Information: Geographical location maps and floor plans of the enterprise’s business premises and warehouse addresses, as well as commercial property ownership certificates, red lease contracts, or site usage certificates, to prove ...
- Source: drugdu
- 395
- August 14, 2024
【EXPERT Q&A】What are Indonesia SAS certification, SNI certification and LS certification respectively?

Drugdu.com expert’s response: The Indonesian SAS, SNI, and LS certifications are different certification systems in Indonesia that cater to various industries and product types. Below is a detailed introduction to each: Ⅰ. Indonesian SAS Certification 1.Definition and Background: The SAS certification is a “Special Access Scheme” established by the Indonesian government in response to emergencies such as the COVID-19 pandemic. It allows the government to directly import urgently needed medical devices without first obtaining an import distribution license. This policy was announced by the Indonesian Ministry of Health through its official website, aiming to expedite the registration and approval process for critical medical equipment during emergencies such as pandemics. 2.Applicable Products: The SAS certification primarily targets medical devices that are urgently needed in Indonesia, including surgical gowns (including masks, personal protective equipment, medical goggles), liquid chemical disinfectants (including disinfectants, hand sanitizers), surgical gloves, patient examination gloves, clinical electronic thermometers, respirators, etc. 3.Application ...
- Source: drugdu
- 471
- August 12, 2024

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