Drugdu.com expert's response:

International Regulatory Framework and Core Requirements for Medical Device Registration

I. Regulatory Systems in Major Target Markets

United States (FDA)

Legal Basis: Federal Food, Drug, and Cosmetic Act (FD&C Act).

Risk-Based Classification:

Class I (Low Risk): Examples include surgical blades and bandages. Typically requires enterprise registration and product listing; some products are exempt from 510(k).

Class II (Moderate Risk): Examples include ultrasound devices and infusion pumps. Requires 510(k) submission (demonstrating substantial equivalence to a predicate device) or De Novo classification request.

Class III (High Risk): Examples include cardiac pacemakers and artificial joints. Requires Pre-Market Approval (PMA) with clinical trial data and production facility inspection reports.

Quality System: Must comply with FDA QSR (21 CFR Part 820), covering design controls and production process validation.

Special Requirements: High-risk products require clinical trials to verify safety and efficacy; some products need animal testing data.

European Union (MDR/IVDR)

Legal Basis:

Medical Devices Regulation (MDR 2017/745): Covers general medical devices.

In Vitro Diagnostic Regulation (IVDR 2017/746): Covers in vitro diagnostic devices.

Risk-Based Classification:

Class I (Low Risk): Examples include medical masks and surgical gloves. Requires self-declaration of conformity and appointment of an EU Authorized Representative (EU AR).

Class IIa/IIb (Moderate-High Risk): Examples include X-ray machines and dialysis equipment. Requires review of technical documentation and clinical data by a Notified Body.

Class III (High Risk): Examples include artificial heart valves and HIV diagnostic reagents. Requires comprehensive assessment by a Notified Body and inclusion in the EUDAMED database.

Core Requirements:

Clinical Evaluation Report (CER) must include equivalence analysis or clinical trial data.

Unique Device Identification (UDI) system for full lifecycle traceability.

Post-Market Surveillance (PMS) plan with regular Periodic Safety Update Reports (PSURs).

China (NMPA)

Legal Basis: Regulation on the Supervision and Administration of Medical Devices (2021 Revision).

Risk-Based Classification:

Class I (Low Risk): Examples include medical cold compress patches. Subject to filing management.

Class II (Moderate Risk): Examples include ultrasound diagnostic instruments. Requires approval from provincial drug regulatory authorities.

Class III (High Risk): Examples include vascular stents and implantable brain pacemakers. Requires review and issuance of a registration certificate by the National Medical Products Administration (NMPA).

Core Requirements:

Clinical evaluation pathways include same-product comparison or clinical trials (mandatory for high-risk products).

UDI implementation will be phased in, covering all Class III medical devices by 2026.

Priority review channel for innovative products, with approval timelines shortened to within one year.

Other Markets

Australia (TGA):

Classification is similar to the EU, but some products (e.g., software-based medical devices) require additional cybersecurity assessment reports.

Japan (PMDA):

Requires review by a Recognized Certification Body (RCB); high-risk products must submit clinical trial data and ethics committee approval documents.

Canada (Health Canada):

Classification aligns with the FDA, but requires submission of Canadian agent information and bilingual (English/French) labeling.

II. International Standards and Harmonization Initiatives

ISO Standards

ISO 13485: Quality management system standard for medical devices, covering design, development, production, installation, and servicing.

ISO 14971: Risk management standard for medical devices, requiring systematic assessment of risks throughout the product lifecycle.

IEC Standards

IEC 60601 Series: Safety standards for medical electrical equipment, covering electrical safety and electromagnetic compatibility (EMC).

IEC 62304: Standard for the software lifecycle process of medical software, applicable to software-based medical devices.

Global Harmonization Task Force (GHTF) and IMDRF

Promote regulatory convergence across countries, such as:

Unique Device Identification (UDI): Mandated by major global markets.

Clinical Evaluation Technical Document (CTD): Unified format requirements to streamline multinational registration processes.

III. Key Compliance Considerations

Classification Accuracy: Incorrect classification may lead to registration failure or regulatory risks (e.g., low-risk products subjected to high-risk requirements).

Clinical Evidence Sufficiency: High-risk products require Randomized Controlled Trial (RCT) data; moderate-risk products may rely on literature reviews or same-product comparisons.

Quality System Alignment: Ensure consistency between quality manuals, procedural documents, and actual production processes to avoid "documentation-practice gaps."

Labeling and Instructions Compliance: Must include intended use, contraindications, and warnings, while complying with language requirements of target markets (e.g., 24 official EU languages).

Post-Market Regulatory Response: Establish adverse event reporting mechanisms and update risk assessment documents promptly (e.g., PSURs in the EU, PMA annual reports in the U.S.).