Expert Q&A – Page 2 – media

【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
- 102
- 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
- 114
- 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
- 119
- 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
- 75
- November 12, 2025
【EXPERT Q&A】How to apply for a medical device production license?

Drugdu.com expert’s response: To apply for a Medical Device Manufacturing License, enterprises need to follow a systematic process that covers material preparation, review stages, and key compliance points, as outlined below: Pre-Application Core Condition Self-Check Qualification Foundations Medical Device Registration: Possession of a valid Medical Device Registration Certificate and product technical requirement documents for the intended medical device production. Business License Scope: The business license must explicitly include medical device manufacturing within its scope of operations. Production Conditions Facilities: Adequate production facilities matching the scale of operations, including cleanrooms (compliant with ISO 14644 standards for sterile medical devices) and storage areas. Provide property ownership certificates or lease agreements. Equipment: Equipped with primary production equipment (e.g., injection molding machines, sterilization equipment) and inspection instruments (e.g., microbiological testers, mechanical testers). A detailed equipment list should be provided. Personnel: Production, quality, and technical leaders must possess relevant professional qualifications (e.g., degrees in biomedical ...
- Source: drugdu
- 80
- November 10, 2025
【EXPERT Q&A】Which laws, regulations and system standards must medical devices comply with?

Drugdu.com expert’s response: The medical device industry is subject to a multi-tiered regulatory framework of laws and regulations and standards at both domestic and international levels, covering the entire product lifecycle management. The following provides an explanation from four perspectives: legal framework, international standards, domestic regulations, and key compliance considerations. I. Legal Framework: Global and Regional Core Regulations China’s Regulations on the Supervision and Administration of Medical Devices Core Positioning: The “basic law” for medical device supervision, clarifying classification management, registration/filing, production/operation/usage requirements, and legal liabilities. Key Provisions: Classification Rules: Products are categorized into Class I, II, and III based on risk levels, with differentiated regulatory oversight (e.g., stringent approval for Class III). Registration and Filing: Class I devices undergo filing management, while Class II and III devices require technical evaluation and system verification, along with submission of clinical evaluation data (some Class II devices may be exempted). Unique Device Identification ...
- Source: drugdu
- 135
- November 7, 2025
【EXPERT Q&A】What requirements does the FDA have for the unique identification (UDI) of medical combination products?

Drugdu.com expert’s response: I. Which combination products does the FDA regulate? First, clarify the scope The FDA’s UDI rules primarily target medical device components, but combination products (such as drug – device combinations or device – drug co – packaged products) need to be treated differently based on their types. In simple terms: If the device is the main function in a combination product (for example, a drug – eluting stent, where the core is the stent): It must be labeled with a UDI, and the drug’s NDC code cannot be used as a substitute. If the drug is the main function (for example, a prefilled syringe, where the core is the drug inside): If it has already been labeled with an NDC code, the device part does not need to be additionally labeled with a UDI (but if the device components are sold separately, they still need to be ...
- Source: drugdu
- 145
- November 5, 2025
【EXPERT Q&A】Why do Class II and Class III medical devices need to be registered?

Drugdu.com expert’s response: Class II and Class III medical devices require registration, primarily for the following reasons: I. Regulatory Requirements The Regulations on the Supervision and Administration of Medical Devices explicitly stipulate that Class II and Class III medical devices must undergo registration management. Medical devices that have not been registered are prohibited from being sold and used in the market. This is a fundamental principle for the standardized operation of the medical device industry, which enterprises must adhere to in order to ensure lawful business operations. II. Risk Control Class II medical devices carry moderate risks: Examples include thermometers, sphygmomanometers, and electrocardiographs. If there are issues with the product quality or safety, it may lead to misdiagnosis, mistreatment, or certain harm to the patient’s body. Class III medical devices pose higher risks: These include devices such as cardiac pacemakers, artificial joints, and implantable cardiac stents. These products are typically used to ...
- Source: drugdu
- 89
- October 29, 2025
【EXPERT Q&A】What is the Unique Device Identifier (UDI) for medical devices?

Drugdu.com expert’s response: The Unique Device Identifier (UDI) is a core tool in the international regulatory landscape for medical devices, designed to enable precise traceability and management throughout the entire lifecycle of medical devices via standardized coding. Its core components, implementation logic, and value are outlined below: I. UDI Composition: Dual-Code Synergy for Precise Identification The UDI consists of two parts—the Device Identifier (DI) and the Production Identifier (PI)—forming a “static + dynamic” dual-recognition system: Device Identifier (DI): Serves as the foundational identity code for medical devices, encompassing registrant/filing entity information, model specifications, and packaging hierarchy. For example, the DI of a specific brand of cardiac stent uniquely identifies its manufacturer, product model, and packaging format (e.g., single unit or boxed). The DI remains stable once assigned, ensuring traceability of basic product information. Production Identifier (PI): Acts as the dynamic information code for medical devices, covering production batch numbers, serial numbers, manufacturing ...
- Source: drugdu
- 155
- October 27, 2025
【EXPERT Q&A】Is it mandatory to have a stability test protocol and report for stress testing during the pharmaceutical R&D process?

Drugdu.com expert’s response Yes, stability test protocols and reports are mandatory for stress testing in the pharmaceutical R&D process. The reasons are as follows: I. Regulatory Requirements Consistency in International and Domestic Regulations: Whether it is China’s NMPA, the U.S. FDA, or the international ICH guidelines, all explicitly mandate that stress testing must be conducted for active pharmaceutical ingredients (APIs), accompanied by comprehensive stability test protocols and reports. These documents are essential prerequisites for drug marketing authorization, and their absence will directly result in application rejection. Essential Materials for Marketing Authorization: Stability test protocols and reports constitute core documentation for drug registration submissions. Regulatory authorities review these files to assess the quality controllability and safety of pharmaceutical products. II. Logical Imperatives in R&D Guiding Subsequent R&D Stages: Stability test protocols meticulously document critical information such as test methods, conditions, and sampling points, providing a foundation for subsequent accelerated and long-term ...
- Source: drugdu
- 145
- October 24, 2025

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