Expert Q&A – Page 2 – media

【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
- 88
- 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
- 107
- 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
- 88
- 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
- 79
- 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
- 74
- June 5, 2026
【EXPERT Q&A】What certifications are required for the export of medical device products to Russia? How to do it?

Drugdu.com expert’s response: Core Conclusion: To export medical devices to Russia, you must obtain two things — a Medical Device Registration Certificate issued by Roszdravnadzor (Federal Service for Surveillance in Healthcare), and an EAC Certificate of Conformity (COC or DOC). The registration certificate is the prerequisite to sell; the EAC is the customs clearance pass. Both are mandatory. I. What Certifications Are Required 1. National Medical Device Registration Certificate (Most Critical — Must Have) This is a registration certificate issued by Roszdravnadzor (Federal Service for Surveillance in Healthcare). All medical devices (Class 1, 2a, 2b, 3) must have this certificate to be sold in Russia. Without it, import and sale are prohibited. The certificate is typically valid permanently but requires periodic maintenance. 2. EAC Certificate of Conformity (Mandatory for Customs Clearance) Medical devices are high-risk products, so they follow the EAC Certificate of Conformity (COC) pathway, not DOC. Samples must ...
- Source: drugdu
- 94
- June 3, 2026
【EXPERT Q&A】Is INMETRO certification required for the export of civilian masks to Brazil?

Drugdu.com expert’s response: In general, ordinary “civilian masks / non-medical masks” exported to Brazil are usually not regulated as medical devices or subject to INMETRO certification in the same way. It should also not be simply assumed that “all masks must obtain INMETRO certification.” The key is to first determine how the product is positioned in Brazil: I. If it is a civilian protective mask / non-medical mask This type of mask is generally closer to a consumer product or textile-based protective product. It should not claim medical use, surgical use, antiviral treatment, disease prevention, or other medical functions. The main compliance focus is usually on labeling, Portuguese instructions, materials, product safety, and the responsibility of the importer. Whether specific testing is required depends on the Brazilian importer and local regulatory requirements. II. If it is a medical surgical mask Then it is no longer an ordinary civilian mask. It ...
- Source: drugdu
- 84
- June 1, 2026
【EXPERT Q&A】What testing and certification are required for the export of medical device products?

Drugdu.com expert’s response: Medical device export testing and certification requirements are not determined by “export” as a general concept. They mainly depend on the target market + product category + risk classification. The same product may face very different requirements when exported to the EU, the United States, the UK, or Southeast Asia. Generally, the requirements can be assessed from the following aspects: I. Basic General Requirements 1. ISO 13485 Quality Management System Certification ISO 13485 is one of the most common quality management system certifications for medical device companies. It is often recognized by overseas customers, registration authorities, and procurement channels. It is not a “market access certificate” for every country, but it is usually an important basic document for medical device export. ISO 13485 focuses on whether the company has established a quality management system that meets medical device regulatory requirements, including design and development, production control, risk ...
- Source: drugdu
- 92
- May 29, 2026
【EXPERT Q&A】What certifications are required for the export of active pharmaceutical ingredients to Japan?

Drugdu.com expert’s response: I. Mandatory Core Certifications MF (Master File) Registration Authority: Japan PMDA / Ministry of Health, Labour and Welfare (MHLW) Purpose: Full API technical dossier registration, linked review with Japanese pharmaceutical companies Requirement: Must be submitted through a domestic Japanese agent; valid for 5 years AFM (Approved Foreign Manufacturer) Designation Basis: Japan Pharmaceutical and Medical Device Act (PMD Act) Purpose: Legal export qualification for overseas API manufacturers Requirement: Renewed every 5 years; export prohibited without AFM Japan GMP Compliance (MHLW Ordinance No. 179) Basis: ICH Q7 + Japan GMP Method: PMDA on-site inspection Outcome: GMP Compliance Certificate, valid for 5 years II. Required Supporting Documents (Per Batch / Ongoing) Japanese domestic agent (responsible for submission, communication, and handling inquiries) GQP (Good Quality Practice) Quality Agreement (signed with Japanese MAH) Per-batch CoC (Certificate of Compliance) — batch number / specifications / test results / expiry date Certificate of Origin ...
- Source: drugdu
- 98
- May 27, 2026
【EXPERT Q&A】The Difference Between a Ventilator and an Oxygen Concentrator

Drugdu.com expert’s response: Although both contain the word “breathing” in their names, ventilators and oxygen concentrators are two completely different categories of medical devices that solve different problems. In one sentence: A ventilator helps you breathe — when stop working, it does the job for them. An oxygen concentrator helps you get more oxygen — your lungs still work, but the air you breathe in doesn’t contain enough oxygen, so it raises the oxygen concentration for you. Their working principles are completely different. A ventilator uses positive pressure to force gas (air or an air-oxygen mix) into your lungs, or applies pressure during exhalation to help push the air out. It replaces or assists your respiratory muscles (diaphragm, intercostal muscles) and the entire ventilation process. An oxygen concentrator, on the other hand, filters nitrogen out of the air, enriches the oxygen, and outputs high-concentration oxygen (usually above 90%). It does not participate in your breathing ...
- Source: drugdu
- 99
- May 25, 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.