Advanced Change Assessment in Technical Documentation for Regulatory Experts

Change is constant throughout the lifecycle of a medical device, but not all changes are created equal. While many global regulations provide guidance on change assessment, they often overlook one crucial area: how revisions in submitted technical documentation (TD) impact regulatory pathways.

In this article, we draw on extensive international experience—spanning the EU MDR, U.S. FDA, MDSAP, ASEAN, and China NMPA—to clarify which technical changes demand new registration, re-testing, or regulatory notification.

Why Not Every TD Update Matters

Medical device manufacturers routinely revise technical documents across a product’s lifecycle. However, only key changes—those that alter safety, performance, or regulatory compliance—require notification or re-approval. The idea that every update to the 100+ files submitted during initial registration needs to be re-submitted is simply unmanageable and not supported by most competent authorities.

🌍 Where Home Country Approval Is Required

In many ASEAN markets, a Free Sales Certificate (FSC) serves as evidence of home country approval. While the EU and US do not require an FSC, most Southeast Asian regulatory bodies mandate it. Any change in product certification—like updates to the FSC—usually requires at least a change notification, or in case of significant modifications, a change registration.

🧪 Where Local Testing Is Mandated

Certain markets require testing in local certified labs, regardless of international data:

China

Local Testing Requirement, Type testing at NMPA labs

USA

Usability testing per FDA guidance

Brazil

ANATEL and INMETRO certification

Russia

GOST-R type testing

Japan

Functional testing by PMDA

Korea

KTL/KTC for electrical safety and EMC

Key Change Factors That May Trigger Re-Testing

Change in Intended Use or Indications for Use
- Triggers reassessment in FDA 510(k) and EU MDR Article 120.
- Affects classification, labeling, and risk profile.
Introduction of New Models or Variants
- Even minor design changes may require verification of worst-case configuration (per IMDRF principles).
Updates in Critical Specifications
- Alterations in voltage, precision, or performance range may invalidate prior IEC 60601 test reports.
Change in Materials or Critical Components
- Can lead to retesting under ISO 10993 for biocompatibility or renewed electrical testing.
Deviations from Localized Standards
- IEC/ISO tests may not be sufficient; localized versions (e.g., GB in China, NBR in Brazil) prevail.
Connectivity and Wireless Features
- Adding Wi-Fi, Bluetooth, or RFID mandates ANATEL (Brazil) or SRRC (China) certification.
Software Updates and Cybersecurity Patches
- Major releases affecting functionality, control algorithms, or interface require revalidation under IEC 62304 and possibly FDA cybersecurity guidance.
Power Supply or EMC-Related Changes
- Triggers full retesting for INMETRO, KTL, or GOST-R standards.

Special Note on China: Product Technical Requirements (PTR)

PTRs are unique to China NMPA and serve as the design output for type testing. Updates to PTRs must be handled with caution.

Key triggers for PTR-based retesting:

Changes in critical specifications
New or modified references to Chinese standards or pharmacopoeia
Updates to visible performance features documented in the original testing report

General rewriting or formatting changes to PTR do not require notification unless they affect compliance testing.

When Labelling Triggers a New Registration

Changes to labeling—including Instructions for Use (IFU), UDI-DI, or product codes—can be regulatory sensitive depending on the market:

Region of Labelling Change Sensitivity

China

High – IFU triggers seperate registration, comparison table is needed

Brazil

High – Label and IFU are integral to INMETRO approval

Japan

Medium – Product code and intended use tied to Shonin approval

USA

Medium – FDA watches for implied changes in indications or target users

Low to moderate – Unless intended use or safety-related labeling changes

Note: UDI-DI changes typically require database updates (e.g., GUDID, EUDAMED) but may not necessitate full re-registration unless tied to a functional change.

Verification & Validation Retesting Frequency (Best Practices)

While not always required by regulation, manufacturers should adopt these lifecycle-based V&V timelines:

Test summary: every 2–4 years
Re-validation (biocompatibility, EMC, etc.): every 5–10 years
Software verification: upon major version release, or if cybersecurity vulnerabilities are identified

e.g. Human Factors and Usability Engineering (FDA Guidance)

According to the FDA’s Human Factors guidance, a new usability test is triggered by:

New or modified critical tasks
UI design changes
Past use errors
Revised training or labeling
New user groups, environments, or use scenarios
Introduction of use-related hazards

This aligns with standards such as ANSI/AAMI HE75 and FDA-recognized usability design controls.

Where No Change Assessment Guidance Exists

Some lower-risk markets or legacy registration systems offer limited change assessment rules. Here, internal Design Control (per ISO 13485:2016) is key. Manufacturers may conduct internal assessments without external submission—but documentation must remain audit-ready.

Smart Change Assessment Strategy

Knowing which changes affect regulatory status helps avoid unnecessary re-submissions. Here’s how to stay proactive:

🧠 Bundle minor changes into one registration cycle
🧊 Use model freezing to stabilize documentation per market
🛠️ Plan multiple variants with tiered specs to accommodate future changes
🤖 Deploy AI-supported decision trees or consulting tools for smarter evaluations

Need Support?

Our consulting service provides:

📋 Change matrices comparing pre- and post-change documentation
📢 Clear change justifications and letter for authorities and distributors
🔧 Custom decision trees based on local guidance (FDA, NMPA, PMDA, ANVISA, etc.)
📈 Optimized product strategies across markets