Expert Q&A – Page 14 – media

【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
- 273
- 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
- 218
- 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
- 260
- August 12, 2024
【EXPERT Q&A】FDA Approves new colorectal cancer Screening method, How will it be implemented?

Drugdu.com expert’s response: The Food and Drug Administration (FDA) in the United States has approved a novel screening method for colorectal cancer (CRC) known as Shield Blood Test, with the following specific implementation details: Ⅰ. Target Population The Shield Blood Test is approved for use in screening the average-risk population aged 45 or older for colorectal cancer. This is based on the high incidence of CRC within this age range and the importance of screening for early detection and treatment. Ⅱ. Detection Principle The Shield Blood Test is a qualitative in vitro diagnostic test designed to detect CRC-derived mutations in cell-free DNA (cfDNA) collected from blood samples using the Guardant Blood Collection Kit. This test assesses an individual’s risk of developing cancer by identifying specific biomarkers associated with CRC in the blood. III. Testing Process Sample Collection: Blood samples are collected from patients by physicians or other healthcare professionals using ...
- Source: drugdu
- 160
- August 9, 2024
【EXPERT Q&A】What do regulatory and non-regulatory markets mean?

Drugdu.com expert’s response: Drug regulatory market and non-regulatory market are two relative concepts, and they have significant differences in the regulation, production and sale of drugs. Ⅰ. Pharmaceutical Regulatory Market The pharmaceutical regulatory market can be understood as one that adheres to the standards and guidelines set forth by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). These markets typically operate under stringent legal and regulatory frameworks, imposing rigorous oversight on drug research and development, production, and sales. Specifically, the pharmaceutical regulatory market necessitates that drugs comply with relevant quality and safety standards and undergo rigorous approval processes before being marketed and sold. In such markets, government regulatory authorities rigorously supervise and manage drugs to ensure their quality and safety. Ⅱ. Unregulated Market The unregulated market, on the other hand, refers to markets that operate in violation of local laws and regulations. These markets ...
- Source: drugdu
- 216
- August 7, 2024
【EXPERT Q&A】Why should the medical device industry strengthen compliance management under the normalization of collection?

Drugdu.com expert’s response: The main reasons for medical device industry to strengthen compliance management under the normalization of centralized procurement can be summarized as follows: I. Policy Drives and Strengthened Regulation 1.Normalization of Centralized Procurement Policy: The normalization of centralized procurement in the pharmaceutical industry refers to the long-term, stable, and institutionalized practice of governments or relevant agencies to conduct bulk procurement of medical products and services such as drugs and medical devices. This model aims to reduce procurement costs, improve procurement efficiency, ensure the quality and supply of drugs and medical devices, thereby meeting the basic medical needs of the people. Under the centralized procurement policy, medical device companies need to pay more attention to compliance management. 2.Strengthened Regulatory Efforts: With the promotion of numerous national policies such as medical anti-corruption, centralized procurement, and joint procurement, medical reform has been fully integrated into the overall process of deepening reforms, and regulatory ...
- Source: drugdu
- 186
- August 5, 2024
【EXPERT Q&A】What are the FDA-approved Consensus Standards for medical devices?

Drugdu.com expert’s response: FDA-recognized consensus standards for medical devices are a set of standards recognized by the U.S. Food and Drug Administration (FDA). These standards are developed by standardization organizations such as ISO, IEC, ASTM, and others, aiming to ensure the safety, effectiveness, and quality of medical devices. These standards cover various aspects of medical devices, including design, manufacturing, testing, clinical evaluation, and risk management. Ⅰ.Source of Standards: Consensus standards are usually developed by professional standard organizations like the International Organization for Standardization (ISO), International Electrotechnical Commission (IEC), and American Society for Testing and Materials (ASTM). These organizations, with the participation of a wide range of industry experts and stakeholders, create internationally recognized technical requirements and guidelines. Ⅱ.FDA Recognition: The FDA reviews and recognizes these standards, considering them to meet the FDA’s regulatory requirements. Recognized standards are listed in the FDA’s “Recognized Standards” list. Manufacturers can refer to these standards ...
- Source: drugdu
- 251
- August 2, 2024
【EXPERT Q&A】How to build the quality management system of aseptic IVD for medical devices?

Drugdu.com expert’s response: The establishment of a quality management system (QMS) for sterile in vitro diagnostic (IVD) medical devices is a complex and systematic process aimed at ensuring product safety, effectiveness, and compliance with regulatory requirements. Below is a detailed, professional step-by-step approach, referencing the Medical Device Manufacturing Practice and relevant regulatory mandates: I. Define Quality Policy and Objectives 1.Establish Quality Policy: The enterprise shall articulate a quality policy that embodies its commitment to medical device quality and patient safety. 2.Set Quality Objectives: Based on the quality policy, set specific, measurable quality objectives, such as product conformity rates and customer satisfaction levels. II. Establish Organizational Structure and Responsibilities 1.Setup Management Organization: Create a management structure tailored to medical device production, clearly defining the responsibilities and authorities of each department. 2.Appoint Management Representative: The corporate leader should designate a management representative responsible for establishing, implementing, and maintaining the QMS. 3.Clarify Responsibilities and Authorities: ...
- Source: drugdu
- 163
- July 31, 2024
【EXPERT Q&A】What is the specific process of medical device product registration?

Drugdu.com expert’s response: The medical device product registration certificate is a necessary credential for legal marketing and sales of medical device products. Its application process involves multiple stages, aiming to ensure the safety, effectiveness, and compliance of the products. Below is a detailed breakdown of the specific process for obtaining a medical device product registration certificate, divided into six phases. I. Preparation Before applying for registration, applicants need to thoroughly understand relevant national regulations and policies, including the “Regulations on the Supervision and Administration of Medical Devices” and the “Measures for the Administration of Medical Device Registration,” to ensure product compliance. At the same time, prepare necessary application materials, which include but are not limited to: 1.Enterprise Qualification Certificates: such as business licenses, medical device production licenses, etc. 2.Product Technical Data: detailing technical specifications, performance parameters, production processes, quality standards, etc. 3.Product Instructions: comprehensively describing usage methods, precautions, warning information, ...
- Source: drugdu
- 235
- July 29, 2024
【EXPERT Q&A】What qualifications do foreign trade enterprises need to agent drug export?

Drugdu.com expert’s response: The qualifications required for foreign trade enterprises to act as agents for pharmaceutical exports primarily encompass the following aspects: I. Basic Qualifications 1.Foreign Trade Management Right: Foreign trade companies must possess general foreign trade import and export management rights, which serve as the fundamental prerequisite for acting as agents for pharmaceutical exports. This right permits the company to engage in or act as an agent for the import and export of various goods and technologies, except for those commodities and technologies whose import and export are restricted or prohibited by the state. 2.Registration: Foreign trade companies need to register with relevant government departments. For instance, they must register with the Ministry of Foreign Trade and Economic Cooperation to obtain import and export qualifications and with the Entry-Exit Inspection and Quarantine Bureau to acquire a quarantine registration code. These registrations are crucial steps to ensure compliance with regulations ...
- Source: drugdu
- 168
- July 26, 2024

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.