ISO13485 vs. GMP: Critical for Medical Device MAH Contract Manufacturing
Release Time:
2025-12-31
Per China’s Medical Devices Registration Administration Method, the Marketing Authorization Holder (MAH) system separates medical device registrants from manufacturers, boosting industry flexibility while raising demands on registrants’ responsibilities and management capabilities. For Medical OEM clients seeking Chinese MAH contract manufacturing partners, supply chain compliance is pivotal—and ISO13485 and GMP are the two core certification focus areas.
Per China’s Medical Devices Registration Administration Method, the Marketing Authorization Holder (MAH) system separates medical device registrants from manufacturers, boosting industry flexibility while raising demands on registrants’ responsibilities and management capabilities. For Medical OEM clients seeking Chinese MAH contract manufacturing partners, supply chain compliance is pivotal—and ISO13485 and GMP are the two core certification focus areas.
Many clients mistakenly equate ISO13485 certification with GMP compliance. In reality, while they share basic compliance logic, GMP imposes far stricter, mandatory requirements for medical device production—making it a non-negotiable threshold for MAH contract manufacturing. Clarifying their differences is key to accurate partner screening and risk mitigation.
I. Core Similarities: ISO13485 & GMP
As core medical device compliance systems, ISO13485 and GMP share three key commonalities, all aimed at ensuring product safety and effectiveness:
1. Risk management as core: Both require full-lifecycle risk management—from design and raw material procurement to production, inspection, and post-marketing surveillance—with risk identification, assessment, and control measures.
2. Emphasis on process control: Both shift focus from "result inspection" to production process control, using standardized operating procedures (SOPs) and parameter monitoring to ensure consistency and eliminate non-conforming products at the source.
3. Mandate for continuous improvement: Both require regular internal audits, management reviews, and data-driven corrective/preventive actions to optimize quality management systems.
II. Key Differences: Why GMP Is a Hard Threshold for MAH Contract Manufacturing?
ISO13485 is a general quality management guideline, while GMP is a mandatory regulation for Chinese medical device production. For MAH contract manufacturing, GMP’s stricter, more targeted requirements make it indispensable. Key differences:
1. Nature: Voluntary vs. Mandatory
ISO13485 is a voluntary ISO standard, certified by third parties, acting as a basic passport for global supply chains. GMP, a mandatory NMPA regulation, applies to all Chinese medical device manufacturers (including MAH-entrusted ones) with no voluntary certification—violations lead to production suspension, fines, or license revocation, invalidating MAH contract manufacturing compliance.
In contrast, GMP is a mandatory regulation formulated by China’s National Medical Products Administration (NMPA). All enterprises engaged in medical device production in China—including those entrusted by MAHs—must strictly comply. There is no requirement for active certification applications, but enterprises are subject to regular regulatory inspections (unannounced inspections, routine inspections, special inspections, etc.). Violations of GMP requirements result in penalties such as production suspension, fines, or revocation of production licenses, directly invalidating production qualifications. Critically, if a partner fails to meet GMP standards, the compliance of the entire MAH contract manufacturing arrangement is compromised.
2. Scope: Full Lifecycle vs. Production-Focused
ISO13485 covers the full medical device lifecycle (design, sales, maintenance, etc.), adaptable to various enterprise types. GMP focuses exclusively on production, with detailed mandatory requirements for environments, equipment, personnel, materials, process control, and inspection/release—directly targeting MAH contract manufacturing’s core quality risks.
3. Control Depth: Framework vs. Rigid Specifications
ISO13485 provides flexible framework-level requirements (e.g., no specific cleanroom parameters). GMP imposes rigid, detailed specs: e.g., Class 100,000+ cleanrooms for implants, mandatory monitoring/validation of environmental parameters, and strict batch record rules (no arbitrary alterations, 2-year retention post-expiration)—minimizing production risks.
4. Supervision: Market-Driven vs. Government-Mandated
ISO13485 is market-driven, supervised by third-party audits. GMP relies on government oversight (NMPA) via routine, special, and unannounced inspections. For MAH contract manufacturing, regulators audit both manufacturers’ GMP compliance and MAHs’ management responsibilities—violations penalize both, endangering product marketing qualifications.
III. Key Tips for OEM Clients: Prioritize GMP Compliance
For OEMs seeking Chinese MAH partners, clarify these three critical points:
1. Don’t equate ISO13485 with GMP. ISO13485 is basic, but GMP is mandatory. Request the "Medical Device Production License" and verify recent GMP inspection results/no violation history.
2. Verify production-stage GMP details. Focus on cleanroom control, equipment validation, batch records, and material traceability during on-site evaluations.
3. Clarify MAH-manufacturer responsibilities. MAHs bear ultimate quality liability, manufacturers for production quality—define this in agreements to ensure effective MAH supervision and GMP-compliant production.
In short, ISO13485 is the global medical device quality "common language," while GMP is China’s non-negotiable production bottom line. For OEMs, GMP compliance is key to mitigating MAH contract manufacturing risks. Choosing a regulator-verified GMP-compliant partner ensures product quality and project success.
It normally takes 1-2 years to get GMP certified, and every product need its own GMP certification, but chooseing a partner who already have GMP certification for other medical products will be much more easier as they already went through the process and it can greatly reduce the lead time you need to wait before your product is allowed to Go Market at China.
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