Expert Q&A – media

【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
- 27
- 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
- 51
- 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
- 51
- 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
- 63
- 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
- 60
- 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
- 59
- 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
- 65
- 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
- 68
- May 25, 2026
【EXPERT Q&A】What Are the Specific Requirements for Equivalence Demonstration Under the EU MDR?

Drugdu.com expert’s response: EU MDR stipulates in Annex XIV that if a manufacturer wishes to cite the clinical data of a marketed device (predicate device) to support its own clinical evaluation, it must first prove equivalence between the two devices. MDR assesses this on a dimension-by-dimension basis across technical characteristics, biological characteristics, and clinical characteristics, and the overall requirements are significantly stricter than the old MDD regulation. The core principle is: the two devices must be “used under similar conditions”, meaning there are no significant clinical differences in safety and clinical performance. I. Technical Characteristics MDR requires the manufacturer to prove that the two devices are highly similar in terms of technology, with the core being “used under similar conditions.” The specific items to compare include: Design and specification performance: The design principles and physical/chemical properties should be similar. Key performance parameters such as energy intensity, tensile strength, viscosity, surface characteristics, wavelength, ...
- Source: drugdu
- 77
- May 22, 2026
【EXPERT Q&A】What standards are there for quality management in medical device enterprises?

Drugdu.com expert’s response: Quality management is the one thing you simply cannot avoid in the medical device industry. From domestic to international, from production to distribution, from risk to software — every link is governed by its own set of standards. Let’s walk through them by actual business scenarios, not by boring categories. First, the Two Hardest Rules in China The one for manufacturing is called GMP (Good Manufacturing Practice). The latest version is NMPA Announcement No. 107 of 2025, effective November 1, 2026. It nearly doubles the number of clauses compared to the old version — expanded from 8 chapters to 15. The core message in one sentence: from R&D to the factory gate, every step must be monitored, documented, and traceable. The management representative and quality head must be full-time, and the quality department holds a veto right. The one for distribution is called GSP (Good Supply Practice). The latest version is NMPA ...
- Source: drugdu
- 75
- May 20, 2026

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