Comprehensive Guide to International Registration of Medical Devices: Certification, European Representation, and Core Requirements Analysis

Against the backdrop of increasingly fierce competition in the global medical market, expanding into international markets has become an important strategy for medical device companies. This article will systematically review the key steps in international registration of medical devices, including the CE certification process, key registration points for the US FDA, selection criteria for EU authorized representatives (EUs), and special requirements for each country, providing a one-stop solution for enterprises.

1、 Overview of International Medical Device Certification System

The certification framework of the global mainstream market presents diversified characteristics, mainly divided into three types of regulatory models:

EU CE certification system: Based on risk level classification (Class I, IIa, IIb, III), it is required to comply with MDR (EU 2017/745) or IVDR (EU 2017/746) regulations

US FDA registration system: Implement product classification management (Class I, II, III), requiring completion of enterprise registration, product listing, and pre-market notifications such as 510 (k)/PMA

Other important markets: including China NMPA registration (classified management), Japan PMDA certification (with designated local agent), Canada Health Canada license, etc

Risk management is the common core of regulation in various countries, and the higher the product risk level, the stricter the approval requirements. For example, EU Class III implantable devices require a complete clinical evaluation report, while US Class III products typically require PMA approval.




2、 Analysis of the entire process of EU CE certification

1. Product classification and compliance path selection

According to MDR regulations, medical devices are divided into:

Class I (low-risk, such as tongue depressors): Self conformity declaration

IIa category (low to medium risk, such as hearing aids): requires review by a notified body

Class IIb (medium to high risk, such as ventilators): comprehensive technical document review

Class III (high-risk, such as heart stents): strictest review process




The key steps include:

Determine product classification and applicable regulations

Choose a conformity assessment path (11 different procedures)

Prepare technical documents (including design documents, risk analysis, clinical data, etc.)

Implement a quality management system (ISO 13485 certified as best practice)

Select and undergo review by the notified body (for IIa and above products)

Sign the conformity declaration and affix the CE mark




2. Clinical evaluation requirements

All CE certified devices must undergo clinical evaluation, including:

Existing clinical data evaluation

Conduct new clinical research when necessary

Continuously updated evaluation report (PSUR)




3、 Key points for the management of EU authorized representatives (EUs)

According to Article 11 of the MDR, non EU manufacturers must designate a European representative, whose core responsibilities include:

As a legal liaison within the European Union

Save technical documents and compliance statements

Cooperate with regulatory requirements of the competent authorities

Report serious incidents and on-site safety corrective measures




The selection criteria for European agents should pay attention to:

Professional qualifications (requiring expertise in medical device regulations)

Service capability (multilingual support, coverage of target market)

Compliance Record (No Regulatory Penalty History)

Emergency response mechanism (ability to quickly handle emergencies)

A typical service agreement should specify:

Service scope and division of responsibilities

File retention period (at least 10 years after product launch)

Cost structure and adjustment mechanism

Termination clauses and transitional arrangements




4、 Special Requirements for FDA Registration in the United States
1. Registration and Listing Process
Obtain DUNS Number
Complete enterprise registration (updated from October to December each year)
Submit device column name information
Submit 510 (k), De Novo, or PMA applications based on product classification

2. 510 (k) pre-market notification
Substantial equivalence proof is crucial and requires:
Detailed comparison of comparative instruments
Performance test data
Biocompatibility report (if applicable)
Sterilization validation (for sterile products)

3. Quality system requirements
21 CFR Part 820 specifies cGMP requirements, including:
Design control program
Process validation
Corrective and Preventive Action (CAPA) System
Device History Record (DHR) Management

5、 Suggestions for optimizing international registration strategies
Global Registration Roadmap Plan: Prioritize breaking through CE/FDA dual certification and utilizing this data to support applications in other markets
Modularization of technical documents: Establish core technical files and supplement specific content according to national requirements
Regulatory resource integration: utilizing the mutual recognition agreement (MDSAP) between the EU MDR and the US FDA to reduce duplicate audits
Lifecycle management: Establish a change control process to ensure continuous updates of registration information
Digital transformation is changing the registration process. Suggestions:
Submit technical documents in eCTD format
Using AI tools to monitor regulatory changes
Establish an electronic quality management system

With the end of the EU MDR transition period (fully implemented on May 26, 2027) and the increasing emphasis on real-world evidence (RWE) by the FDA, medical device companies need to establish forward-looking registration strategies and integrate compliance requirements into product lifecycle management in order to gain a competitive advantage in the global market.