Expert Q&A – Page 16 – media

【EXPERT Q&A】How does the law regulate the production and sale of medical devices?

Drugdu.com expert’s response: In the production and sales of medical devices, countries have strict laws and regulations to regulate them. Taking China as an example, the Measures for the Supervision and Administration of Medical Device Production are formulated to strengthen the supervision and administration of medical device production, standardize medical device production activities, and ensure the safety and effectiveness of medical devices. The measures clarify the laws, regulations, rules, mandatory standards and quality management specifications that should be observed in medical device production activities, and require medical device registrants and filers to be responsible for the safety and effectiveness of listed medical devices. At the same time, according to the different levels of medical device risks, China also implements classified management for medical device production, requiring enterprises engaged in different types of medical device production to obtain corresponding production licenses or make filings according to law. In addition, the country ...
- Source: drugdu
- 292
- June 21, 2024
【EXPERT Q&A】What is the application and reliability of flexible circuit boards in medical devices?

Drugdu.com expert’s response: Flexible circuit boards (FPC) are widely used in medical devices, especially in scenarios that require high precision, high reliability, and high stability. Due to their strong flexibility and adaptability, FPC can be designed and manufactured according to the shape and size of the product, making them ideal for applications such as electrocardiographs, medical probes, and medical imaging devices. In addition, FPC also has characteristics such as vibration resistance, impact resistance, and anti-aging, further improving its reliability in medical devices.
- Source: drugdu
- 356
- June 19, 2024
【EXPERT Q&A】What is a medical device traceability system?

Drugdu.com expert’s response: The medical device traceability system is a full-process traceability management platform system that connects all aspects of medical device production materials, processing, and consumers, making the entire chain visible and transparent. The system consists of raw material and processing plant traceability management, production traceability management system, logistics distribution scanning system, sales market medical device traceability system, and consumer query system. Its main functions include the collection and tracking of production raw material information, medical device life cycle management, pre-event prevention, in-process control, and post-event traceability. Through this system, enterprises can improve the quality of medical devices, facilitate tracking management, and also provide consumers with a channel for query and traceability.
- Source: drugdu
- 242
- June 18, 2024
【EXPERT Q&A】The requirement of an EU Representative for CE certification brings several benefits and impacts?

Drugdu.com expert’s response: The benefits and impacts of requiring an EU Representative for CE certification can be summarized as follows: Benefits : 1.Communication Bridge: An EU Representative serves as an intermediary between manufacturers and EU authorities, effectively communicating and handling technical, regulatory, and after-sales issues related to products. This bridging role significantly simplifies the communication process between manufacturers and EU authorities, improving the efficiency of problem-solving. 2.Compliance Assurance: Through an EU Representative, manufacturers can ensure their products meet EU regulatory requirements, mitigating the risk of compliance violations due to unfamiliarity with local regulations. The EU Representative’s familiarity and understanding of EU regulations can provide manufacturers with guidance and support in terms of compliance. 3.Clear Responsibility: In the event of product issues, EU authorities can directly contact the EU Representative to take prompt action, such as product recalls. This clear responsibility approach enhances the efficiency of problem resolution, reducing delays ...
- Source: drugdu
- 144
- June 14, 2024
【EXPERT Q&A】What is FDA certification, and why is it necessary?

Drugdu.com expert’s response: FDA certification refers to the process in which the Food and Drug Administration of the United States reviews a product and recognizes that the product meets its qualification requirements. This certification is based on rigorous scientific evaluation and regulatory review to ensure that the safety, effectiveness, and quality of the product meet standards. The importance and reasons of FDA certification： 1.Ensuring product safety: FDA certification requires products to meet strict safety and effectiveness standards to ensure that consumers are purchasing safe and reliable products that do not pose a risk to human health. 2.Promote public trust: FDA certification is an important recognition of product quality and safety by the public, which can improve consumer trust and recognition of products and increase market competitiveness. 3.Encourage enterprises to operate in compliance with regulations: By obtaining FDA certification, enterprises need to strictly comply with relevant regulations and quality standards, which ...
- Source: drugdu
- 269
- June 12, 2024
【EXPERT Q&A】How to apply for a medical device class III business license?

Drugdu.com expert’s response: To obtain a Class III Medical Device Operating License, you would need to follow a specific process and meet certain requirements. Here is a general outline of the steps in English: 1.Prepare Application Materials: Gather all necessary documents, including the “Application Form for Medical Device Operating License” (signed by the legal representative or stamped with the company seal), proof of identity, education, and appointment documents for the legal representative. Also, provide copies of the “Pre-Approval Notice for Enterprise Name” or “Business License” issued by the Administration for Industry and Commerce. Additionally, submit proof of property or lease agreements with the lessor’s property certificate, as well as layout plans of the business premises and warehouse. 2.Submit Application Materials: Submit the prepared application materials to the local Food and Drug Administration or Market Regulatory Department. 3.Review and Onsite Inspection: The local Food and Drug Administration or Market Regulatory Department ...
- Source: drugdu
- 261
- May 22, 2024
【EXPERT Q&A】What does the 4-digit number next to the CE mark on medical devices mean?

Drugdu.com expert’s response: The 4-digit number next to the CE mark on medical devices indicates the Notified Body identification number (or Module D number). These digits identify the Notified Body that has certified the device’s quality management system. It signifies the registration number of the certifying body, indicating that it has assessed the quality management system of the medical device and confirmed its compliance with the relevant European Union directive requirements. This number is crucial for tracking the validity of the certification and for regulatory purposes.
- Source: drugdu
- 269
- May 16, 2024
【EXPERT Q&A】What does FDACFR21 in the United States refer to?

Drugdu.com expert’s response: The U.S. FDACFR21 regulations refer to Title 21 of the Code of Federal Regulations (CFR), which encompasses regulations established under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This set of regulations, overseen by the U.S. Food and Drug Administration (FDA), governs various aspects of the production, distribution, labeling, advertising, and safety of food, drugs, medical devices, cosmetics, and other related products. CFR Title 21 includes provisions covering: 1.Drug Quality and Manufacturing Practices: Regulations concerning quality control, processes, equipment, raw materials, packaging, and other aspects of drug manufacturing. 2.Food Labeling and Ingredients: Requirements for information on food labels, ingredient lists, nutrition labeling, etc., ensuring consumers receive accurate information. 3.Medical Device Registration and Reporting: Mandates for medical device manufacturers to register and report, as well as comply with relevant quality management system requirements. 4.Cosmetic Safety and Labeling: Standards for cosmetic safety, ingredient restrictions, and labeling requirements to ...
- Source: drugdu
- 301
- May 13, 2024
【EXPERT Q&A】What is OTC? What products do FDA need to apply for OTC?

Drugdu.com expert’s response: OTC stands for “Over-the-Counter,” referring to medications that can be purchased without a prescription from a healthcare professional. These medications are typically used to treat common health issues such as headaches, colds, fevers, and mild pains. In the United States, the Food and Drug Administration (FDA) regulates OTC drugs, and certain products require an application for OTC status before they can be sold on the market. Products that need to apply for OTC status according to the FDA include: 1.New Drugs: Drugs that have not been previously marketed require FDA approval before being sold as OTC products, regardless of their composition or effects. 2.Prescription Drugs: Some prescription drugs can apply for OTC status after undergoing clinical studies and safety assessments to demonstrate their safety and effectiveness. 3.Previously OTC Products with Safety Concerns: Certain OTC products may be required by the FDA to halt sales or undergo further ...
- Source: drugdu
- 371
- May 8, 2024
【EXPERT Q&A】What is CAPA for Medical Devices?

Drugdu.com expert’s response: Corrective and Preventive Actions (CAPA) in medical devices refer to a series of measures taken in response to identified issues or defects. CAPA aims to ensure the safety and effectiveness of medical devices and compliance with regulatory requirements. These measures include: 1.Corrective Actions: Steps taken to address existing issues or defects, aimed at eliminating or correcting their root causes to prevent recurrence. This may involve repairs, improvements to product design, or enhancements to manufacturing processes. 2.Preventive Actions: Measures taken to address potential issues or defects, intended to prevent future quality problems. This may include improving product design, updating manufacturing processes, or enhancing training. CAPA is an essential component of the quality management system for medical devices, often detailed in standards such as ISO 13485. Implementing CAPA helps ensure the safety, effectiveness, and quality of medical devices, while also ensuring compliance with regulatory requirements.
- Source: drugdu
- 304
- May 6, 2024

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