Medical Device Quality Frameworks in China, Japan, and Korea

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Introduction

In the fast-paced medical device industry, product quality is essential to guaranteeing patient safety and public confidence. Across the world, regulatory bodies have established stringent quality systems to manage and enforce standards throughout the life cycle of a device. In Asia, three major medical device markets – China, Japan, and Korea – have developed their own systems for managing medical device manufacturing quality. Whereas China and Korea have Good Manufacturing Practice (GMP) frameworks, Japan has a Quality Management System (QMS) system governed by a unique ordinance.

China: Medical Device GMP System

Regulatory Evolution and Alignment with Global Standards

China has, in recent years, made sweeping reforms to improve its medical device quality control framework to better align with international best practices. The foundation of the system is the Good Manufacturing Practice (GMP) system for medical devices, managed by China’s National Medical Products Administration (NMPA). In 2014, China released a new version of its GMP standard – a comprehensive overhaul of its strategy. Another significant revision was put forth in January 2025 with the release of a new draft called “Medical Device Manufacturing Quality Management Standards.”

The revised version added 49 new provisions, capturing lessons learned over a decade of experience. It adds more precise definitions and places more emphasis on risk-based principles similar to those used in ISO 13485, the international standard for medical device quality systems. The updated standards place more emphasis on risk management, post-market surveillance, and internal training.

Comprehensive Lifecycle Coverage

China’s GMP regulations cover all stages of the product lifecycle of a medical device. Manufacturers must show compliance from the initial R&D phase to production, packaging, labeling, storage, and distribution. More specifically, the areas of focus include:

  • Design control and validation
  • Raw material and supplier management
  • In-process quality control
  • Sterility assurance and labeling accuracy
  • Distribution record-keeping and recall readiness

Product Testing and Verification

A medical device needs to go through type testing at an NMPA-certified laboratory prior to being marketed in the China market. Medical devices are subjected to testing for conformity with Mandatory National Standards (GB standards) and Industry Standards (YY standards). Test requirements are dependent on the type of product and may include:

  • Biocompatibility and toxicology
  • Electrical safety of electronic devices
  • Sterilization process validation
  • Performance benchmarking

These tests represent an important step towards ensuring that products comply with China’s requirements for safety and effectiveness.

QMS Implementation and Integration with ISO Standards

In addition to GMP compliance, manufacturers are required to have a Quality Management System (QMS) complying with both Chinese requirements and ISO 13485. The QMS should contain the following components:

  • Document management systems
  • CAPA (Corrective and Preventive Actions)
  • Audits of suppliers and qualification protocols
  • Validation of production process
  • Risk management procedures in compliance with ISO 14971

Documentation needs to be comprehensive and current, with mandatory record retention periods to facilitate traceability and ease of inspection.

Post-Market Surveillance and Adverse Event Reporting

China mandates ongoing oversight even after a device has been marketed. Basic post-market requirements include:

  • Regular internal quality inspections
  • Participation in the National Adverse Event Monitoring System
  • Reporting of safety concerns or adverse events
  • Implementation of corrective actions and, if needed, product recalls

To ensure the quality of medical devices in China, the NMPA, in coordination with the National Institute for Food and Drug Control, announced in late 2024 that they would implement annual sampling inspection between June and August. 66 Categories of products, including hydrocolloid dressings, dental implants, and breast implants, etc. will be sampled from hospitals, clinics, warehouses, and other distribution channels. The testing will be implemented based on Technical Product Requirements and relevant device standards.

Testing will be performed by accredited organizations under provincial NMPA oversight, and test results will be made public. Manufacturers with a record of two consecutive years of non-compliance will be subject to a factory inspection.

In addition, provinces will implement their own yearly sampling plan, typically initiated 1–2 months following the national plan. Refusal to cooperate will result in listing in the Enterprise Credit File and possible re-inspection.

Maintaining Compliance Amid Regulatory Change

China’s regulatory environment is always evolving. Medical device manufacturers need to keep themselves updated on the most recent NMPA notices, engage with local regulatory experts, and attend industry conferences to stay current. Regular internal audits, training employees, and staying one step ahead of regulatory trends with proactive engagement are the key to maintaining market approval.

Japan: Quality Management System (QMS) Ordinance

Regulatory Authority and Scope

Japan has a different approach to medical device quality by enforcing a Quality Management System (QMS) overseen by the Pharmaceuticals and Medical Devices Agency (PMDA). Japan’s QMS Ordinance No. 169 is primarily derived from ISO 13485 but includes provisions specific to Japan.

Japan’s QMS Ordinance No. 169 consists of several chapters, and Chapter 2 is the same as ISO 13485:2003. Compliance with Chapter 2 can be guaranteed through documentation if the manufacturer is already ISO 13485 certified. Compliance with chapters 3 to 5 usually requires on-site quality audits.

The scope of inspection depends on the classification of the device:

 

Class of Product QMS Audit Conducted By
Class I QMS Audit is not required
Class II Registered Certification Body (RCB) or PMDA
Class III RCB or PMDA
Class IV PMDA

Class II and III device manufacturers will be audited by either the RCB or PMDA, and audit results are accepted reciprocally.

QMS audits are required before a marketing approval is issued. Once approval is obtained, manufacturers must undergo an audit every 5 years to maintain their approval. These audits may cover:

  • The Marketing Authorization Holder’s (MAH) head office
  • All listed manufacturing locations
  • Unlisted facilities, if critical functions (e.g., management reviews or CAPA) are performed there

Inspection Outcomes

Upon a successful audit, the PMDA or RCB provides a “QMS Conformity Attestation” (Kijun Tekigo Sho). Similar to ISO audits, Japan’s QMS audits also have audit reports with findings and items for correction. The attestation from these reports is necessary for continued marketing of the device in Japan.

Manufacturers with multiple manufacturing sites or products can consolidate multiple QMS audits. Japan still maintains strict regulations and the right to audit any plant that is involved in important quality processes, even if it may not be officially listed. Since 2015, Japan has been a participant in the Medical Device Single Audit Program (MDSAP), an international agreement between Japan, the US, Australia, Brazil, Canada, and the EU. This program enables a single MDSAP report to be used across these countries, helping unite QMS standards internationally and reduce auditing efforts.  If the foreign medical device manufacturer has MDSAP, it is more likely that a paper audit, instead of an on-site audit, will be done.

Korea: Medical Device GMP System

Framework and Regulatory Body

Korea’s quality system for medical devices is GMP-oriented and regulated by the Ministry of Food and Drug Safety (MFDS). It is mandatory for manufacturers and importers interested in marketing their products in the Korean market to meet GMP compliance.

Scope of Application

The GMP audit is required for:

  • Initial product approval
  • Import registration
  • Device approval for use in a clinical trial
  • Recertification or updates to manufacturing processes

The Korean GMP system consists of various forms of audits, including:

  • Initial audits for new manufacturing or importing entities
  • Periodic recertification audits
  • Amendment audits when there is a change in facilities, processes, or suppliers

These audits evaluate whether products are manufactured consistently in a safe and effective manner.

Integration with Global Systems: MDSAP

In March 2025, MFDS declared its intention to integrate its GMP evaluations with the Medical Device Single Audit Program (MDSAP). This initiative will facilitate regulatory compliance for foreign manufacturers. Within this framework, applicants may apply for Korean GMP certification and MDSAP simultaneously, thus preventing duplication and accelerating market entry.

To further speed up the approval timelines for devices, Korea has recently licensed quality management review organizations to conduct GMP audits on Class III devices. This is meant to cut down MFDS bottlenecks and enhance regulatory review efficiency.

The MFDS also updates its standards periodically and invites public comment on draft updates. Industry response to such consultations is necessary to ensure transparency and fairness in quality requirements.

Conclusion

Medical device quality frameworks in China, Japan, and Korea all share the common goal of safeguarding the safety and effectiveness of medical device products. However, each program has its unique structure, audit procedures, and regulatory philosophies.

China continues to move its GMP toward better alignment with ISO practices while keep an emphasis on national standards for testing and lifecycle regulation. Japan’s QMS system is well-developed and heavily dependent on ISO 13485, with transparent timelines and responsibilities for audits. Korea offers a flexible, internationally harmonized GMP system that allows for simultaneous domestic and global compliance through MDSAP.

Manufacturers aiming to succeed in these markets must be educated on the nuanced requirements of each framework and employ comprehensive quality strategies that adhere to both local and international standards. Through investment in effective QMS implementation, proactive regulatory engagement, and collaboration with local experts, medical device manufacturers can ensure smoother market entry and continuous compliance in Asia’s largest medical device markets.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)

Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.