Expert Q&A – media

【EXPERT Q&A】What impacts will there be if pharmaceutical enterprises export without certification?

Drugdu.com expert’s response: If a pharmaceutical enterprise fails to complete necessary certifications for export, it will face severe consequences such as blocked market access, intensified legal risks, expanded economic losses, damaged brand reputation, and decreased supply chain stability. The specific impacts are as follows: I. Blocked Market Access: Products Unable to Enter Target Markets European Union Market Lack of CE Certification: EU law mandates that medical devices, pharmaceuticals, and other products must pass CE certification. Otherwise, products will be seized or confiscated by customs, and enterprises may face hefty fines, market withdrawals, and recalls of in-use products. For example, medical devices without CE certification cannot be sold in the 27 EU member states, directly losing access to the European market. Upgraded MDR Regulations: The EU’s new Medical Device Regulation (MDR) significantly raises certification standards, requiring enterprises to invest more resources to ensure product compliance, further increasing market access difficulties for ...
- Source: drugdu
- 34
- July 21, 2025
【EXPERT Q&A】What are the document requirements for the registration of Class II medical devices in China?

Drugdu.com expert’s response: I. Enterprise Qualifications and Basic Documents Medical Device Registration Application Form Must include detailed information such as product name, model, specifications, intended use, manufacturing process, and quality control methods, accompanied by product photographs. Enterprise Qualification Certificates Business license. Medical Device Manufacturing License (if already obtained). Identity certificates and educational/professional qualification certificates of the legal representative, enterprise person in charge, and quality manager. Power of Attorney Required if the registration is handled by someone other than the legal representative or enterprise person in charge, with an authorized signature and official seal. II. Technical Documentation and Product Information Product Technical Files Design principles, structural features, and performance specifications: Detailed descriptions of technical parameters, functional characteristics, and testing methods. Bill of materials: Includes specifications, models, quality standards, and supplier qualification documents for raw materials, components, and assemblies. Manufacturing process flowchart: Must annotate key and special processes, accompanied by process descriptions. ...
- Source: drugdu
- 83
- July 18, 2025
【EXPERT Q&A】How many types of EU CE certification are there?

Drugdu.com expert’s response: The EU CE certification is primarily classified into three types based on certification modes (COC, AOC, DOC) and multiple types based on product directives, while the certification path also involves different module combinations. Here is a detailed classification and explanation: I. Three Types Based on Certification Modes COC (Certificate of Compliance) Issuing Authority: Third-party organizations (e.g., intermediaries or testing and certification bodies). Content: Typically accompanied by technical documentation (TCF) such as test reports, and enterprises are also required to sign a Declaration of Conformity. Applicable Scenarios: Applicable to a variety of situations, whether for AOC or other products requiring certification under specific modes (e.g., B+D, B+E, H, etc.), a COC certificate may ultimately be obtained. AOC (EC Attestation of Conformity) Issuing Authority: EU Notified Bodies (NB). Content: According to EU regulations, only NB organizations are qualified to issue such certificates. Applicable Scenarios: Typically arises when product certification ...
- Source: drugdu
- 81
- July 16, 2025
【EXPERT Q&A】How to standardize drug information?

Drugdu.com expert’s response: Standardizing drug information is a critical step in enhancing medical data quality, facilitating information sharing, and ensuring medication safety. Below are the specific methods and steps to achieve drug information standardization: I. Clarify Standardization Objectives and Scope Define Core Objectives Improve Data Consistency: Ensure consistent naming and dosage representations of the same drug across different systems. Support Cross-System Interoperability: Enable data exchange among hospitals, pharmacies, and regulatory agencies. Ensure Medication Safety: Avoid medication errors caused by information confusion. Meet Regulatory Requirements: Comply with national drug coding standards, electronic health record (EHR) specifications, etc. II. Define Standardization Scope Basic Information: Drug names, ingredients, dosage forms, specifications, manufacturers, etc. Clinical Information: Indications, usage and dosage, contraindications, adverse reactions, etc. Administrative Information: Drug codes, classifications, prices, inventory, etc. Research Information: Pharmacokinetic parameters, clinical trial data, etc. Establish a Unified Drug Information Standard System Adopt International/National Standards Drug Coding: Utilize internationally ...
- Source: drugdu
- 85
- July 14, 2025
【EXPERT Q&A】What are the standards and procedures for compliance review?

Drugdu.com expert’s response: I. Standards for Compliance Review The standards for compliance review serve as benchmarks to ensure that the actions of enterprises or organizations are lawful and compliant, primarily covering the following three aspects: Legal and Regulatory Requirements National Laws and Regulations: These include the Constitution, laws, administrative regulations, departmental rules, and local regulations, such as the Company Law, Labor Law, and Cybersecurity Law. International Treaties and Regulatory Provisions: For foreign-involved enterprises, compliance with the laws and regulations of the host country where investments are made, international conventions (e.g., GDPR), and bilateral treaty agreements is required. Industry Regulatory Requirements: Examples include capital adequacy ratios and risk management regulations in the financial sector, as well as medical device approval processes in the healthcare industry. Industry Standards and Best Practices Industry Codes: Examples include the Basel Accords in the financial sector and ISO 13485, the quality management system standard for medical devices. Social Responsibility ...
- Source: drugdu
- 93
- July 11, 2025
【EXPERT Q&A】How effective is Dula peptide in lowering blood sugar?

Drugdu.com expert’s response: Dulaglutide is a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist with significant glucose-lowering effects, particularly suitable for patients with type 2 diabetes mellitus. Its specific manifestations are as follows: I. Core Glucose-Lowering Mechanisms Promotion of Insulin Secretion: By mimicking the body’s natural GLP-1, dulaglutide activates GLP-1 receptors, increasing cyclic adenosine monophosphate (cAMP) levels in pancreatic β-cells. This precisely stimulates insulin secretion when blood glucose levels rise (e.g., after meals), thereby lowering blood glucose. Inhibition of Glucagon Release: Glucagon is a hormone that raises blood glucose. Dulaglutide suppresses its secretion, further reducing hepatic glucose output and aiding in glycemic control. Delay of Gastric Emptying: By slowing the passage of gastric contents into the small intestine, dulaglutide prolongs carbohydrate absorption time, preventing sharp postprandial blood glucose spikes and achieving stable glycemic control. II. Clinical Efficacy Data Significant Reduction in Glycated Hemoglobin (HbA1c): Multiple studies demonstrate that after 24 weeks of dulaglutide treatment, HbA1c levels decrease by ...
- Source: drugdu
- 89
- July 9, 2025
【EXPERT Q&A】Can large-scale equipment that has exceeded its service life continue to be used?

Drugdu.com expert’s response: Whether overdue large-scale equipment can continue to be used requires discussion based on equipment type. Medical devices are strictly prohibited from being used beyond their expiration dates, special equipment can be extended for use only after passing inspection or assessment and undergoing registration changes, while other equipment should be decided upon after a comprehensive evaluation of safety risks. The specific analysis is as follows: Medical Devices: Strictly Prohibited from Being Used Beyond Expiration Dates Legal Basis: According to Article 39 of the Regulations on the Supervision and Administration of Medical Devices and Article 10 of the Provisions on the Management of Instructions and Labels for Medical Devices, the instructions and labels of medical devices must indicate the production date, service life, or expiration date. Continuing to use medical devices beyond their marked expiration dates will result in administrative penalties, including confiscation of illegally produced, operated, or used medical devices, fines, ...
- Source: drugdu
- 65
- July 7, 2025
【EXPERT Q&A】Why do we need CE certification?

Drugdu.com expert’s response: The CE certification serves as a “passport” for products to enter the European market, with its core purpose being to ensure that products comply with the EU’s fundamental requirements for safety, health, and environmental protection, while also facilitating the free flow of goods within the EU internal market. The following are the main reasons and specific values for enterprises to pursue CE certification: I. Legal Compliance: Avoiding Market Access Barriers EU Mandatory Requirement: The CE mark is a mandatory certification symbol for product safety, health, and environmental protection in the EU. According to EU regulations (such as the Low Voltage Directive, Electromagnetic Compatibility Directive, and Machinery Directive), products without the CE mark are prohibited from being sold in the EU market. Avoiding Legal Risks: Products that fail to pass CE certification may face customs seizure, mandatory recalls, hefty fines, or even criminal penalties. For example, electronic and ...
- Source: drugdu
- 64
- July 4, 2025
【EXPERT Q&A】How is medical device software recognized and classified in the European Union?

Drugdu.com expert’s response: I. How to Determine if a Software is Medical Device Software? In simple terms, for the European Union (EU), a software is considered medical device software (MDSW) when it meets three conditions simultaneously: It Performs Medical Tasks For example, diagnosing diseases, monitoring conditions, treating patients, or assisting in surgeries. If it merely records exercise steps, reminds users to drink water, or sends notifications to doctors (without involving medical decision-making), it doesn’t qualify. Examples: A software that analyzes electrocardiogram (ECG) data to assess heart disease risk is medical device software; a fitness app that records daily step counts is not. It Processes Data The software should not just store or display data (such as an electronic medical record system). It must analyze, calculate, modify the data, and then generate medical-related results. Examples: A software that automatically marks tumor locations based on computed tomography (CT) images is medical device ...
- Source: drugdu
- 64
- July 2, 2025
【EXPERT Q&A】Why do drugs need to have a patent protection period?

Drugdu.com expert’s response: The reasons for setting a patent protection period for pharmaceuticals mainly include the following aspects: I. Encouraging Innovation and Research Investment High Risks and Costs: Pharmaceutical research and development (R&D) is a lengthy, complex, and costly process. It often takes several years or even decades from drug discovery, preclinical research, clinical trials to eventual market launch, and involves substantial financial investment. For instance, data indicates that the cost of developing a new drug can amount to hundreds of millions of US dollars or more. Patent Incentives: The patent protection period grants pharmaceutical developers exclusive market rights, enabling them to recoup R&D costs and generate profits through drug sales within a specified timeframe. This incentive mechanism encourages enterprises to invest more resources in new drug R&D, thereby driving innovation and development in the pharmaceutical industry. II. Ensuring Drug Quality and Safety Stringent Regulation: The R&D, production, and sale ...
- Source: drugdu
- 110
- June 30, 2025

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.