Drugdu.com expert's response:

 

The medical device industry is subject to a multi-tiered regulatory framework of laws and regulations and standards at both domestic and international levels, covering the entire product lifecycle management. The following provides an explanation from four perspectives: legal framework, international standards, domestic regulations, and key compliance considerations.

I. Legal Framework: Global and Regional Core Regulations

China's Regulations on the Supervision and Administration of Medical Devices

Core Positioning: The "basic law" for medical device supervision, clarifying classification management, registration/filing, production/operation/usage requirements, and legal liabilities.

Key Provisions:

Classification Rules: Products are categorized into Class I, II, and III based on risk levels, with differentiated regulatory oversight (e.g., stringent approval for Class III).

Registration and Filing: Class I devices undergo filing management, while Class II and III devices require technical evaluation and system verification, along with submission of clinical evaluation data (some Class II devices may be exempted).

Unique Device Identification (UDI): Mandates full lifecycle traceability covering production, distribution, and usage.

Adverse Event Monitoring: Enterprises must establish a monitoring system to promptly report and implement risk control measures.

EU's Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Medical Device Regulation (IVDR 2017/746)

Core Changes:

Classification Upgrades: Elevated risk classifications for certain products (e.g., implantable devices, drug-containing devices).

Strengthened Clinical Evidence: Requires more comprehensive clinical data to demonstrate safety and performance.

Economic Operator Responsibilities: Clarifies obligations for manufacturers, importers, and distributors, including UDI implementation and traceability.

Notified Body (NB) Role: Stricter review processes, requiring certification by designated bodies.

U.S. FDA Regulatory Framework

Core Requirements:

510(k) and PMA: Class II devices demonstrate substantial equivalence to predicate devices via 510(k), while Class III devices require Pre-Market Approval (PMA).

QSR 820: Quality System Regulation covering design, production, packaging, and storage.

UDI Rules: Requires product identification to include Device Identifier (DI) and Production Identifier (PI), submitted to the GUDID database.

II. International Standards: Full Lifecycle Quality Management Systems

ISO 13485 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes

Core Elements:

Risk Management: Integrated throughout the product lifecycle, from design to post-market, to identify and control risks.

Documented Controls: Establishment of quality manuals, procedural documents, and records to ensure traceability.

Regulatory Compliance: Explicit alignment with regulatory requirements, such as EU MDR and U.S. QSR 820.

Implementation Significance: Recognized by major global markets (EU, Canada, Australia, etc.), serving as a "passport" for internationalization.

IEC 62304 Medical Device Software – Software Life Cycle Processes

Scope: Applies to medical device software (e.g., AI diagnostic systems, wearable devices).

Core Requirements:

Software Development Process: Defines standards for requirement analysis, design, verification, and maintenance.

Risk Management: Assesses risks of software failures to users in conjunction with ISO 14971.

Documentation Management: Requires retention of development records and test reports to support regulatory reviews.

III. Domestic Regulations: Detailed Production and Operation Requirements

Good Manufacturing Practice (GMP) for Medical Devices and Appendices

Core Content:

Sterile Medical Devices: Requires controlled cleanroom environments, sterilization process validation, and sterile packaging seal testing.

Implantable Medical Devices: Emphasizes raw material traceability, biocompatibility evaluations, and surgical follow-up records.

In Vitro Diagnostic Reagents: Specifies raw material stability studies, reaction system validation, and calibrator traceability.

Implementation Methods: Ensures compliance through system verification (e.g., registration audits, unannounced inspections).

Good Supply Practice (GSP) for Medical Devices

Key Requirements:

Cold Chain Management: Mandates full-process temperature monitoring and recording for devices requiring low-temperature storage (e.g., vaccines, reagents).

Computerized Systems: Requires distribution enterprises to establish information management systems for electronic traceability of inventory.

Personnel Qualifications: Quality management personnel must possess relevant professional backgrounds or training.

Key Compliance Considerations: Enterprise Practice Guidelines

IV. Classification and Registration Strategies

Risk-Oriented Approach: Determine classification based on intended use, contact method, and duration.

Clinical Pathway Selection: Class II devices may be exempted from clinical trials (e.g., via predicate comparison), while Class III devices require trials.

International Registration Synergy: Leverage the Medical Device Single Audit Program (MDSAP) to meet requirements of multiple countries (U.S., Canada, Australia, Brazil, Japan) through a single audit.

UDI Implementation and Data Management

Coding Rules: Obtain UDI from FDA-authorized agencies (GS1, HIBCC, ICCBBA), including DI and PI.

Database Submission: Submit DI, model numbers, and enterprise information to GUDID (U.S.) or China’s NMPA UDI database.

Labeling Requirements: UDI must be directly printed on products (e.g., etching, laser marking); reusable devices may display it on packaging.

Supply Chain Compliance Management

Supplier Audits: Evaluate quality systems of raw material and component suppliers to ensure regulatory compliance.

Distributor Training: Provide technical product information, usage instructions, and adverse event reporting procedures to distribution enterprises.

Recall Mechanisms: Establish product recall procedures, clarifying recall levels, notification methods, and corrective actions.

Continuous Improvement and Regulatory Response

Internal Audits and Management Reviews: Conduct regular internal audits to assess system effectiveness and propose improvements.

Regulatory Engagement: Proactively participate in NMPA-organized training and seminars to stay informed of policy updates.

Digital Transformation: Utilize ERP and MES systems for real-time collection and analysis of production and quality data.

V. Compliance Recommendations

Build a "Regulations + Standards" Dual System: Use ISO 13485 as a framework, integrating domestic GMP and international regulations (e.g., MDR, QSR 820).

Establish a Dedicated Compliance Team: Equip with registration, quality, and clinical experts to ensure end-to-end compliance.

Engage in Industry Collaboration: Join medical device industry associations to share compliance experiences and best practices.

Invest in Smart Tools: Adopt UDI traceability systems and electronic quality manuals to enhance compliance efficiency.

By implementing systematic compliance management, enterprises can mitigate regulatory risks, enhance market competitiveness, and achieve sustainable development.

By editor