Expert Q&A – Page 4 – media

【EXPERT Q&A】Compliance Information to Be Displayed on Medical Device Product Pages

Drugdu.com expert’s response: In accordance with the Quality Management Specifications for Online Sales of Medical Devices which came into effect on October 1, 2025 and relevant regulatory requirements, the following compliance information must be continuously displayed in a prominent position on the medical device product page: ‌Core Product Qualification Information‌ Images of the Medical Device Registration Certificate (for Class II and Class III devices) or the Class I Medical Device Filing Information Form, or the link identifier of the corresponding electronic certificate. ‌General Warning Information‌ For all medical devices sold online in retail mode, the warning statement “Please carefully read the product manual before purchase and use, or purchase and use it under the guidance of medical personnel” must be displayed. ‌Exclusive Warnings for Special Categories‌ For selling contact lenses (contact lenses): The mandatory warning statement “Wearing this product must be fitted by an optometry professional” must be displayed. For selling hearing aids: The mandatory warning statement “Before fitting a ...
- Source: drugdu
- 131
- July 1, 2026
【EXPERT Q&A】Why Do Class III Medical Device Buyers Pay More Attention to Compliance Documents?

Drugdu.com expert’s response: In medical device procurement, communication around Class III products often takes longer than for Class I or Class II products. Many suppliers may feel that buyers are asking “too many details”: registration certificates, production licenses, ISO certificates, CE/FDA documentation, test reports, clinical data, authorization letters, quality system documents, after-sales service plans… Sometimes, the full set of documents has not even been provided before pricing discussions begin. But for Class III medical device buyers, compliance documents are not an extra requirement. They are the first threshold in procurement evaluation. According to China’s Regulations on the Supervision and Administration of Medical Devices, Class III medical devices refer to products with higher risks that require special measures for strict control and management to ensure their safety and effectiveness. Risk classification takes into account factors such as intended use, structural characteristics, and method of use. In other words, Class III products ...
- Source: drugdu
- 119
- June 29, 2026
【EXPERT Q&A】What certifications are required for medical devices to enter the Saudi market?

Drugdu.com expert’s response: The core of entering the Saudi market is mandatory registration and certification with the Saudi Food and Drug Authority (SFDA), along with a series of supporting requirements. The following breaks them down by priority. I. Core Certification That Must Be Completed: SFDA Medical Device Registration This is the only legal entry requirement for all medical devices. Unregistered products cannot clear customs or be sold. Registration Process: Submit registration application through the SFDA online system (MDMA / Saudi Drug Registration System) Submit complete technical documentation; SFDA conducts document review Medium-to-high risk products may be required to provide additional test reports or undergo on-site audits Upon approval, a registration certificate is issued (typically valid for 5 years, renewable upon expiry) II. Products Classified by Risk Level — Requirements Differ SFDA classifies medical devices into four classes. The higher the class, the stricter the review: Class I (Low Risk) — e.g., surgical blades, ...
- Source: drugdu
- 160
- June 22, 2026
【EXPERT Q&A】How to apply for a medical device business license?

Drugdu.com expert’s response: Obtaining a Medical Device Distribution License — the key is to first clarify which class of devices you intend to distribute, as the process for Class II and Class III is completely different. Clarify: Are you applying for a “License” or “Filing”? Class I (Low Risk) — e.g., surgical scalpels, gauze, stethoscopes: Filing during business registration is sufficient. No license required. Class II (Medium Risk) — e.g., blood pressure monitors, thermometers, nebulizers: File with the municipal drug regulatory authority. This is not called a license. Class III (High Risk) — e.g., cardiac stents, CT scanners, ventilators, contact lenses: You must apply for a Medical Device Distribution License from the municipal drug regulatory authority. When people ask about a “license,” they usually mean Class III. The following covers Class III. Application Requirements (Five Mandatory Criteria — All Must Be Met) Personnel: The quality manager must hold a college degree or higher (or intermediate professional ...
- Source: drugdu
- 130
- June 19, 2026
【EXPERT Q&A】What problems do pharmaceutical companies have in the quality management of drug production?

Drugdu.com expert’s response: Common issues in pharmaceutical production quality management are generally concentrated in the following areas: Personnel & Awareness Quality management in many companies remains at the level of “passing inspections” rather than being truly internalized into production habits. Frontline operators have high turnover, training is superficial, and SOP non-compliance is widespread. The quality department lacks authority and often yields to production when output and quality conflict. Data Integrity This is a key regulatory enforcement focus in recent years. Handwritten records are casually altered, electronic data lacks audit trails, abnormal data is deleted without trace, and shared login accounts are common — especially prevalent among small and mid-sized pharma companies. FDA and NMPA requirements on data integrity are tightening, yet many companies’ IT systems are still stuck at the Excel stage. Deviation & Change Control Out of Control When deviations occur, the first instinct is to find a workaround, ...
- Source: drugdu
- 128
- June 17, 2026
【EXPERT Q&A】How do the approval and supervision processes of medical devices ensure their safety?

Drugdu.com expert’s response: The core logic is: risk-based classification → strict pre-market review → continuous post-market surveillance, forming a full lifecycle closed loop. I. Classification: Risk Determines Regulatory Intensity Under the Regulation on the Supervision and Administration of Medical Devices, devices are divided into three classes: Class I (Low Risk): Filing system, formal review only. Examples: medical cotton swabs, surgical gowns. Class II (Moderate Risk): Registration system, reviewed and approved by provincial drug administration. Examples: blood pressure monitors, CT scanners. Class III (High Risk): Registration system, reviewed and approved by the National Medical Products Administration (NMPA). Examples: cardiac stents, artificial joints. Higher risk means stricter review — classification itself is the first safety filter. II. Pre-Market Approval: Four Core Gates Taking Class II and III as examples: Gate 1: Product Technical Requirements & Testing Must complete biological evaluation, electrical safety, performance testing, etc., to prove the product itself is qualified. Class III ...
- Source: drugdu
- 136
- June 15, 2026
【EXPERT Q&A】Do Class II medical device operations require a “license”?

Drugdu.com expert’s response: No. You don’t need a “license” for Class II medical devices — you only need to file a record . To be precise, the term “Class II Medical Device Operation License” itself is incorrect. According to Article 30 of the Medical Device Supervision and Administration Regulations: Class I: No license required, no filing required Class II: No license required, but filing is mandatory. You obtain a Class II Medical Device Operation Filing Certificate Class III: License required. You apply for a Medical Device Operation License So the correct procedure for Class II is: submit filing materials to the municipal-level drug administration department where the enterprise is located. If materials are complete and meet requirements, the certificate is issued on the spot. The filing certificate has no fixed expiry date. When enterprise information changes, a change filing must be processed. When operations cease, the filing must be actively cancelled.
- Source: drugdu
- 151
- June 12, 2026
【EXPERT Q&A】How long does it take to obtain a medical device registration certificate for exporting Chinese medical devices to Malaysia?

Drugdu.com expert’s response: The time required to obtain an MDA medical device registration certificate for exporting Chinese medical devices to Malaysia mainly depends on the product risk class and whether an expedited pathway is used. Standard Processing Time (No Expedited Pathway) Under Malaysia’s Medical Device Act 2012, products are classified into four risk categories: Class A (Low Risk): e.g., gauze bandages, medical rubber plaster, cooling oil → 6–9 months Class B (Moderate-Low Risk): e.g., povidone-iodine solution, disposable sterile obstetric surgical pack → 9–12 months Class C (Moderate-High Risk): 12–18 months Class D (High Risk): 18–24 months Expedited Pathway: As Fast As 30 Working Days This is currently the most notable channel. Malaysia and China have launched a regulatory cooperation program. Products holding a China NMPA registration certificate can apply through the MDA Verification Pathway via a CAB (Conformity Assessment Body) assessment, shortening the approval time to approximately 30 working days. Eligibility: hold NMPA / CE / FDA / TGA registration from ...
- Source: drugdu
- 153
- June 10, 2026
【EXPERT Q&A】What are the document requirements and review difficulties for applying for CE in in vitro diagnostic (IVD) self-testing?

Drugdu.com expert’s response: IVD Self-testing products are classified as Class C under IVDR by default (except for urine glucose/red blood cell/white blood cell/bacteria tests, which are Class B). About 80% of IVD products require Notified Body (NB) review, and self-testing products are almost all in this category. The documentation volume is large, the review cycle is long (Class D can take 18–24 months), and the core difficulties focus on usability studies, clinical performance evidence, and IFU label compliance. I. Mandatory Documentation Checklist 1. Technical Documentation (core, approximately 20+ items) Table of contents (version status, cross-references); manufacturer name and address, product name (all models/specifications), product description (intended use, model list, photos, drawings); device sample identification, declaration of conformity; list of applicable standards, essential requirements checklist (Annex I); risk management report (EN ISO 14971); product history (sales, complaints, change records); manufacturing method (production flowchart); quality control process description (incoming/in-process/final inspection, batch release ...
- Source: drugdu
- 149
- June 8, 2026
【EXPERT Q&A】What is the process for obtaining a medical device business license?

Drugdu.com expert’s response: Key Point: Only Class III medical devices require a Medical Device Business License. Class I needs no license, Class II only requires filing. Here is the complete process: Step 1: Confirm which class you need Class I (low risk): No license needed, e.g., surgical scalpels, gauze, stethoscopes Class II (medium risk): Business filing only, e.g., thermometers, blood pressure monitors, nebulizers Class III (high risk): License required, e.g., cardiac stents, contact lenses, syringes, CT scanners Note: Starting April 2026, new regulations: individual businesses can no longer apply for Class II or Class III licenses/filings. Applications must be made under a corporate entity (except for individual businesses dealing with 13 specific low-risk Class II products). Step 2: Corporate qualification preparation Register a company. The business scope of the business license must include “Class III medical device distribution.” Statutory processing time: 45 working days; in practice, most regions take 15–20 ...
- Source: drugdu
- 129
- June 5, 2026

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.