Expert Q&A – media

【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
- 37
- 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
- 45
- 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
- 52
- 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
- 65
- December 5, 2025
【EXPERT Q&A】When should the continuation registration process for medical devices be initiated?

Drugdu.com expert’s response: The continuation registration of medical devices should generally be applied for with the original registration authority six months before the expiration of the medical device registration certificate. Here is a detailed explanation: I. Legal Basis Regulations on the Supervision and Administration of Medical Devices: It explicitly stipulates that the validity period of a medical device registration certificate is five years. If continuation registration is required upon expiration, an application for continuation registration should be submitted to the original registration authority six months before the expiration date. Measures for the Registration and Filing of Medical Devices: It further refines the application process and requirements for continuation registration, emphasizing that enterprises need to submit applications within the specified time to ensure the validity of the registration certificate. II. Application Time Requirements Apply six months in advance: Enterprises should submit an application for continuation registration to the original registration authority ...
- Source: drugdu
- 83
- December 3, 2025
【EXPERT Q&A】What is the development trend of the veterinary diagnostic reagent industry? Market Size Continues to Grow

Drugdu.com expert’s response: The market size of China’s veterinary diagnostic reagent industry has expanded from 2.2 billion yuan in 2018 to 4.84 billion yuan in 2024, with a compound annual growth rate of 14.04%. It is expected to maintain a growth trend in the coming years. With the rapid development of the breeding industry, the demand for veterinary diagnostic reagents has been on the rise. Meanwhile, the emergence of the pet market has also brought new growth momentum to the industry. For instance, in 2024, there were 71.53 million pet cats and 52.58 million pet dogs in China, and the consumption scale of urban pets (cats and dogs) reached 300.2 billion yuan. The increasing demand for pet medical care has driven the development of the diagnostic reagent market. Continuous Technological Upgrades Detection Technology Iteration: Detection technology has been continuously advancing. For example, CRISPR gene-editing technology has reduced the detection limit ...
- Source: drugdu
- 83
- December 1, 2025
【EXPERT Q&A】What are the requirements of the General Safety and Performance Requirements (GSPR) under the EU medical Device MDR and IVDR regulations?

Drugdu.com expert’s response: The General Safety and Performance Requirements (GSPR) in the EU Medical Device Regulation (MDR) (2017/745) and In Vitro Diagnostic Regulation (IVDR) (2017/746) constitute the core framework for ensuring the safety and effectiveness of medical devices and in vitro diagnostic medical devices. The GSPR requirements permeate the entire lifecycle of medical devices, encompassing design, manufacturing, clinical evaluation, labeling, and post-market surveillance. The specific content is as follows: I. Chapter Division of GSPR The GSPR requirements are detailed in Annex I of the MDR and IVDR and are divided into three chapters: Chapter 1: General Requirements for Risk-Based Management Medical devices must operate in accordance with their intended design and must not endanger the health or safety of patients, users, or third parties. Risks must be minimized as much as possible, and the degree of reduction must not negatively impact the risk-benefit ratio. Manufacturers are required to establish, ...
- Source: drugdu
- 86
- November 28, 2025
【EXPERT Q&A】Is it difficult to obtain a medical device business license? How can one apply for it?

Drugdu.com expert’s response: The handling of medical device business licenses presents certain difficulties, but with systematic preparation and standardized operations, it can be completed successfully. The main challenges lie in complex policies and regulations, stringent technical requirements, cumbersome material preparation, a lengthy approval process, and a scarcity of professional talent. However, enterprises can reduce these difficulties through advance planning, standardized operations, and seeking professional support. The following is a detailed analysis: Difficulties in Handling Complex Policies and Regulations: The handling of medical device business licenses involves numerous regulations such as the “Regulations on the Supervision and Administration of Medical Devices” and the “Measures for the Administration of Medical Device Registration.” These regulations are complex and frequently updated, requiring enterprises to continuously learn and adapt. Otherwise, they may easily fail in their applications due to non-compliant operations. Stringent Technical Requirements: During the handling process, sufficient technical materials and proofs must be ...
- Source: drugdu
- 81
- November 26, 2025
【EXPERT Q&A】What is the development trend of the high-end medical equipment industry?

Drugdu.com expert’s response: I. Continuous Market Expansion Driven by Domestic Production and Globalization Global Market Growth Steady In 2023, the global high-end medical equipment market reached USD 345.4 billion, marking a 6.64% year-on-year increase. By 2030, China’s market size is projected to exceed RMB 300 billion, accounting for 28% of the global share. The United States, Europe, and China are the three core markets, collectively representing over 86% of the total, with China’s growth rate significantly outpacing the global average (CAGR of 27.8% from 2015 to 2023). Accelerated Localization Rate Technological Breakthroughs: Domestic carbon-ion therapy systems, ECMO devices, artificial hearts, and other cutting-edge equipment have achieved localization. Examples include United Imaging Healthcare’s world-first 5T whole-body MRI, Mindray Medical’s clinical-grade photoacoustic imaging system, and MicroPort Robotics’ laparoscopic surgical robot, all breaking foreign monopolies. Policy Support: The National Medical Products Administration (NMPA) has implemented a “proactive intervention, full-cycle guidance” policy for innovative ...
- Source: drugdu
- 94
- November 24, 2025
【EXPERT Q&A】What are active medical devices?

Drugdu.com expert’s response: Active medical devices refer to any medical devices that rely on electrical energy or other forms of energy (such as chemical energy, mechanical energy, etc.) to function, rather than energy directly generated by the human body or gravity. These devices typically require an external power source or built-in energy supply to fulfill their intended purposes and are widely used in various medical fields, including diagnosis, treatment, monitoring, and rehabilitation. I. Core Characteristics Energy Dependency: They must rely on external or internal energy sources (such as batteries, power adapters, chemical cells, etc.) to operate normally. Functional Complexity: They usually incorporate electronic, mechanical, or software components, enabling them to perform precise operations or data processing. Risk Level: According to the “Classification Rules for Medical Devices,” active medical devices are classified as having a higher risk level. They may involve direct electrical stimulation, energy release, or complex control mechanisms that ...
- Source: drugdu
- 99
- November 21, 2025

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