Expert Q&A – media

【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
- 62
- 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
- 63
- 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
- 70
- 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
- 62
- 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
- 81
- 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
- 88
- November 21, 2025
【EXPERT Q&A】What are the requirements for the registration of Class III in vitro diagnostic reagents?

Drugdu.com expert’s response: As high-risk medical devices, Class III in vitro diagnostic reagents have registration requirements covering multiple aspects, as detailed below: I. Management Category and Registration Pathway Management Category: Class III in vitro diagnostic reagents are subject to registration management and are directly approved by the National Medical Products Administration (NMPA). Registration Pathway: For newly developed products not yet listed in the classification catalog of in vitro diagnostic reagents, applicants may directly apply for the registration of Class III in vitro diagnostic reagents or determine the product category in accordance with classification rules, apply to the NMPA for category confirmation, and then apply for product registration or handle product filing. For direct applications for the registration of Class III in vitro diagnostic reagents, the NMPA will determine the category based on the risk level. II. Product Technical Requirements and Registration Inspection Product Technical Requirements: Applicants or filers should formulate ...
- Source: drugdu
- 96
- November 19, 2025
【EXPERT Q&A】How long is the validity period of the ce certification certificate?

Drugdu.com expert’s response: The validity period of a CE certification certificate typically ranges from 1 to 10 years, with the specific duration depending on factors such as the product’s risk level, regulatory updates, and design modifications. Below is a detailed summary of the validity period of CE certification certificates: I. Validity Period Based on Product Risk Level Low-Risk Products: For products such as ordinary toys and general machinery, CE certificates usually have a validity period of 5 years. These products have relatively stable technical standards and lower safety risks, prompting certification bodies to issue long-term valid certificates. Medium-Risk Products: For products like construction products and personal protective equipment, CE certificates generally have a validity period of 3 years. These products require regular reviews of design documentation and production consistency to ensure compliance with new EU standards. High-Risk Products: For products such as implantable medical devices, dangerous machinery, boilers, pressure vessels, ...
- Source: drugdu
- 107
- November 17, 2025
【EXPERT Q&A】What are the differences between domestic generic targeted drugs and those from India?

Drugdu.com expert’s response: There are significant differences between domestically produced generic targeted drugs and Indian-produced generic targeted drugs in terms of research and development foundations, production standards, market regulation, pricing strategies, quality risks, and international recognition. A detailed analysis is as follows: I. Research and Development Foundations and Adaptability to Indications Domestically Produced Generic Drugs: These are typically developed based on extensive domestic clinical data and patient needs, enabling them to more precisely adapt to the genetic characteristics, disease spectra, and medication habits of Chinese patients. For example, domestically produced Gefitinib (Iressa) was optimized during the research and development phase to target the high-incidence mutation types in Chinese patients with non-small cell lung cancer, ensuring efficacy and safety. Indian-Produced Generic Drugs: These rely on global research and development experience, particularly excelling in the field of biosimilars. However, they may not fully consider the specific needs of Chinese patients. For instance, ...
- Source: drugdu
- 114
- November 14, 2025
【EXPERT Q&A】How to apply for a business license for Class I medical devices?

Drugdu.com expert’s response: Class I medical devices do not require a license for business operations, but if production or specific sales activities are involved, a filing certificate is required. The specific application process is as follows: I. Filing Requirements for Business Operations of Class I Medical Devices Situations Requiring No License or Filing If an enterprise is solely engaged in the sales of Class I medical devices (without involvement in production), it only needs to explicitly include “sales of Class I medical devices” in its business scope on the business license, without the need for additional licenses or filings. Situations Requiring Filing Product Filing: If an enterprise sells self-produced Class I medical devices, it needs to submit filing materials to the local municipal drug regulatory authority (drug administration bureau) before the product is marketed, in order to obtain a “Filing Certificate for Class I Medical Devices”. Production Filing: If an ...
- Source: drugdu
- 70
- November 12, 2025

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