Expert Q&A – Page 3 – media

【EXPERT Q&A】What are the considerations to keep in mind when applying for EU CE certification?

Drugdu.com expert’s response: When applying for the EU CE certification, the following considerations should be taken into account to ensure a smooth process and compliance with regulatory requirements: I. Clarify the Scope of Certification and Applicability of Directives Confirm Whether the Product Requires CE Certification: Not all products require CE certification. Only those products that fall within the scope of the EU “CE Directives” or “Regulations” must undergo certification and affix the CE mark. Currently, the EU has issued more than 20 CE-related directives, covering common categories such as electronics and electrical appliances, machinery, medical devices, toys, and building materials. Determine Applicable Directives and Standards: Match the corresponding EU directives (such as the Low Voltage Directive, Electromagnetic Compatibility Directive, Medical Device Regulation, etc.) based on the product type, and verify the latest harmonized standards (such as EN 60335-1 for household appliance safety standards). Avoid invalid certification due to incorrect directive ...
- Source: drugdu
- 85
- December 26, 2025
【EXPERT Q&A】What are the requirements for the registration information of domestic active medical device products?

Drugdu.com expert’s response: The registration materials for domestically manufactured active medical device products need to meet various requirements, as detailed below: I. Basic Document Requirements Table of Contents: It should include all main and sub-headings, indicate the page numbers for each content in the table, and clarify applicability (e.g., whether the CR table of contents is applicable). Glossary of Terms and Abbreviations: Define terms or abbreviations that require clarification based on the actual situation of the registration application materials. Application Form: Fill out and upload the application form with a unified approval code exported from the application system (including the power of attorney), in accordance with the form-filling requirements. Product List: List the model numbers, specifications, structures and components, and accessories of the proposed products in tabular form, along with the identification (such as model or part numbers, unique device identifiers, etc.) and descriptive explanations (such as dimensions, materials, etc.) ...
- Source: drugdu
- 104
- December 24, 2025
【EXPERT Q&A】What are the differences between a ventilator and an oxygen generator?

Drugdu.com expert’s response: Respirators and oxygen concentrators exhibit significant differences in functional positioning, working principles, applicable scenarios, and usage methods. Here is a detailed comparative analysis: I. Core Functional Positioning A respirator is a “respiratory support device” whose core function is to replace or assist human breathing. It addresses two types of issues through mechanical ventilation: Insufficient respiratory drive: Such as respiratory failure or neuromuscular diseases (e.g., amyotrophic lateral sclerosis, spinal cord injuries) that render individuals unable to breathe autonomously. Airway obstruction: Such as sleep apnea syndrome (snoring with breathing pauses) or airway spasms during acute asthma attacks. Respirators not only deliver oxygen but also help expel carbon dioxide through positive pressure, maintaining overall gas exchange in the body. An oxygen concentrator is an “oxygen supplementation device” whose core function is to increase the concentration of inhaled oxygen. It extracts oxygen from the air (with oxygen concentrations reaching over 90%) ...
- Source: drugdu
- 128
- December 22, 2025
【EXPERT Q&A】How can I apply for Class II and Class III medical device certificates the fastest?

Drugdu.com expert’s response: To swiftly apply for Class II and Class III medical device certificates, it is essential to clarify the classification requirements, prepare complete materials, submit the application according to the process, and actively cooperate with the review. Additionally, leveraging professional agency services can enhance efficiency. Below is a detailed explanation: I. Clarify Classification and Requirements Class II Medical Devices: These pose moderate risks and require either business registration or production licensing. Class III Medical Devices: These carry higher risks and must obtain business licensing or production licensing. II. Prepare Application Materials Class II Medical Device Business Registration Materials Registration Application Form: Requires the signature of the legal representative and the company seal. Corporate Qualification Proof: Includes a copy of the business license, with the business scope including “Class II medical device sales” or similar wording. Personnel Qualification Proof: Identification documents and educational or professional title certificates of the ...
- Source: drugdu
- 110
- December 19, 2025
【EXPERT Q&A】What are the content and regulatory requirements for the registration materials of domestic non-active medical devices?

Drugdu.com expert’s response: Domestic Registration of Non-active Medical Devices: Required Submission Materials Covering Six Core Areas Including Enterprise Qualifications, Product Technology, Quality Systems, Clinical Evaluation, Packaging and Labeling, and After-sales Service. Specific Content and Regulatory Requirements Are as Follows: I. Enterprise Qualification Documents Basic Certificates: Provide a copy of the business license (stamped with the official seal and valid), organization code certificate, and tax registration certificate (some regions have merged these into a unified social credit code). If the enterprise already holds a Medical Device Business License, this must also be submitted. Personnel Qualifications: Include identity proofs, academic or professional title certificates for the legal representative, enterprise leader, and quality supervisor, along with work resumes of quality management personnel. Additionally, provide a list of professional and technical personnel with their qualifications (e.g., copies of ID cards, academic certificates, and professional title certificates). Special Qualifications: If the product involves innovative medical ...
- Source: drugdu
- 84
- December 17, 2025
【EXPERT Q&A】What is the process of FDA certification like?

Drugdu.com expert’s response: The FDA certification process varies depending on product type (e.g., medical devices, drugs, food, cosmetics). Below is a detailed explanation of the certification process for medical devices as an example: I. Determine Product Classification Classification Basis: The FDA classifies medical devices into three risk-based categories: Class I (low risk), Class II (medium risk), and Class III (high risk). Classification Impact: The classification determines the subsequent certification pathway and requirements, such as whether a 510(k) submission or Premarket Approval (PMA) application is needed. II. Prepare Application Documents Document Content: Based on the product classification and characteristics, prepare relevant application documents, which may include product descriptions, performance data, clinical trial results (if applicable), manufacturing processes, and quality control information. Document Requirements: Ensure the documents are complete, accurate, and comply with FDA-specified formats and requirements. III. Submit the Application Submission Method: Applications are typically submitted online through the FDA’s electronic submission system ...
- Source: drugdu
- 87
- December 15, 2025
【EXPERT Q&A】How does the FDA of the United States classify medical devices?

Drugdu.com expert’s response: The U.S. Food and Drug Administration (FDA) classifies medical devices into three categories—Class I (low-risk), Class II (medium-risk), and Class III (high-risk)—based on their risk levels, and implements differentiated regulatory requirements for each category. Below is a detailed explanation of the classification logic and regulatory framework: I. Classification Basis: Risk Level and Regulatory Control The FDA’s classification system is grounded in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Medical Device Amendments (MDA), with the core principle that higher risk warrants stricter regulation. Specific classification criteria are as follows: Class I (Low-Risk) Risk Characteristics: Non-invasive, non-life-supporting, with minimal potential harm to the human body. Regulatory Requirements: Implementation of General Controls, including prohibiting the sale of non-compliant products, reporting adverse events, and restricting sales scope. Approximately 93% of Class I devices are exempt from 510(k) submissions, requiring only Enterprise Registration and Product Listing. A minority of Class I devices (e.g., medical gloves, surgical ...
- Source: drugdu
- 92
- December 12, 2025
【EXPERT Q&A】What certifications are required for the export of pharmaceutical products?

Drugdu.com expert’s response: Pharmaceutical products need to obtain four major types of certifications based on the regulatory requirements of the target markets for export: quality management system certification, regional market access certification, production specification certification, and special product-specific certifications, as detailed below: I. Quality Management System Certification (Internationally Recognized) ISO 13485 Certification Scope of Application: Applicable to all medical device companies exporting products. Certification Content: An international standard for the quality management system of medical devices, covering the entire process of design, production, installation, and service. Function: Demonstrates that the enterprise has the capability to consistently produce products that comply with international standards, serving as the “basic threshold” for entering most markets. Regional Market Access Certification (Select Based on Target Market) EU Market CE Certification: Applicable Products: All medical devices (Class I low-risk products require a Declaration of Conformity, while Classes IIa/IIb/III require a CE certificate). Regulatory Basis: Must comply ...
- Source: drugdu
- 111
- December 10, 2025
【EXPERT Q&A】What are the differences between medical device verification and medical device validation?

Drugdu.com expert’s response: Medical device verification and validation are two core aspects of quality management. They have fundamental differences in terms of purpose, scope, methods, and application scenarios, yet they complement each other to jointly ensure the safety and effectiveness of products. Here is a detailed comparative analysis: I. Core Purposes Verification: It answers the question “Has the product been made correctly?” by confirming whether the product strictly adheres to design specifications and technical requirements. Key Question: Do the product’s technical parameters, material properties, software functions, etc., align with the design documents? Example: Checking whether the X-ray dose of a CT scanner complies with the safety threshold specified in the design documents. Validation: It answers the question “Has the correct product been made?” by confirming whether the product can meet user needs and intended uses in real-world usage scenarios. Key Question: Is the product safe and effective under actual clinical, ...
- Source: drugdu
- 101
- December 8, 2025
【EXPERT Q&A】What certifications are required for the export of medical products to Malaysia?

Drugdu.com expert’s response: Medical products exported to Malaysia must primarily obtain certification from the Malaysian Medical Device Authority (MDA), with specific requirements varying based on the product’s risk classification (Classes A-D). Here is a detailed explanation: I. Basic Requirements for MDA Certification 1. Corporate Qualifications Local Registration: Companies must register with the Companies Commission of Malaysia (SSM) and obtain a business license. It is recommended to register as a private limited company (Sdn. Bhd.), which allows 100% foreign ownership, provided there is at least one Malaysian director (who does not need to hold shares). Authorized Representative (AR): If the manufacturer is a foreign enterprise, a local Authorized Representative (AR) in Malaysia must be appointed. The AR assists in communication with the MDA and submission of applications. The AR must obtain a Good Distribution Practice for Medical Devices (GDPMD) certificate, issued by an MDA-authorized Conformity Assessment Body (CAB). This certificate is ...
- Source: drugdu
- 128
- December 5, 2025

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