PMDA Class II vs Class III: GI Endoscopy Device Classification Examples

One of the first — and most consequential — decisions in any Japan PMDA submission is determining your device's regulatory classification. Get it right, and you're on the fastest path to approval. Get it wrong, and you may face unexpected clinical data requirements, longer review timelines, or a complete restart.

This article focuses on GI endoscopy devices and explains the practical differences between Class II and Class III classification, with real-world examples.

Japan's Medical Device Classification System

Under Japan's Pharmaceutical and Medical Device Act (PMD Act), medical devices are classified into four classes based on risk:

Class	Risk Level	Submission Type	Review Body
Class I	Lowest risk	Notification (self-certification)	Prefecture
Class II	Low-moderate risk	Third-party certification or Ministerial approval	RCB or PMDA
Class III	Moderate-high risk	Ministerial approval	PMDA
Class IV	Highest risk	Ministerial approval	PMDA

For most GI endoscopy accessories, the critical distinction is between Class II and Class III.

Class II GI Endoscopy Devices: Examples

Class II devices are considered low-to-moderate risk. For GI endoscopy accessories, Class II typically includes:

Biopsy Forceps

Standard single-use or reusable biopsy forceps for tissue sampling are generally classified as Class II. The key factors:

• Well-established clinical use with extensive safety data
• No energy delivery (not electrosurgical)
• Intended for diagnostic use

Submission route: Third-party certification by a Registered Certification Body (RCB) — faster and less expensive than PMDA direct review.

Hemostatic Clips

Standard through-the-scope (TTS) hemostatic clips for bleeding control are typically Class II:

• Mechanical action only (no energy)
• Established clinical evidence base
• Predicate devices widely approved in Japan

Polypectomy Snares (Cold Snare)

Cold snares for polyp removal without electrosurgical current are generally Class II.

Class III GI Endoscopy Devices: Examples

Class III devices carry higher risk and require direct PMDA review. For GI endoscopy, Class III typically includes:

Electrosurgical Accessories

Any device that delivers electrical energy — including:

• Hot biopsy forceps
• Electrosurgical snares (hot snare polypectomy)
• Needle knives for ESD (endoscopic submucosal dissection)
• APC (argon plasma coagulation) probes

The energy delivery element elevates these to Class III due to the risk of perforation, bleeding, and thermal injury.

ESD/EMR Devices

Devices specifically designed for endoscopic submucosal dissection (ESD) or endoscopic mucosal resection (EMR) are typically Class III:

• Insulation-tip (IT) knives
• Hook knives
• Injection needles with specific ESD indications

Stents with Active Components

Self-expandable metallic stents (SEMS) for biliary or colonic use may be Class III depending on design and indication.

The Classification Decision Process

Determining the correct classification involves:

1. Identifying the applicable classification code in the MHLW classification list (医療機器の分類表)
2. Reviewing PMDA guidance documents specific to your device type
3. Checking for designated controlled medical devices (特定保守管理医療機器) — these have additional requirements
4. Confirming with PMDA via a pre-submission consultation if classification is ambiguous

Why Classification Matters for Your Submission Strategy

The classification directly determines:

• Submission route: RCB certification (faster) vs. PMDA direct approval (longer)
• Clinical data requirements: Class III typically requires more robust clinical evidence
• Timeline: Class II RCB certification can be completed in 6–12 months; Class III PMDA approval typically takes 12–24 months
• Cost: PMDA review fees are significantly higher than RCB certification fees

Common Classification Pitfalls

Underclassifying: Submitting a Class III device as Class II leads to rejection and significant delays. PMDA reviewers are experienced in identifying misclassified devices.

Overlooking combination products: A device that combines a drug or biological component may be subject to different classification rules.

Ignoring Japanese-specific classifications: Some devices classified as Class II in the EU or US are Class III in Japan due to different risk assessment approaches.

How MK Consulting Can Help

At MK Consulting, GI endoscopy device classification is one of our core competencies. We have classified and submitted numerous endoscopy accessories — from biopsy forceps to ESD knives — and have deep familiarity with PMDA's classification guidance and review standards.

Our classification support includes:

• Review of your device against the MHLW classification list
• Analysis of applicable PMDA guidance documents
• Recommendation of the optimal submission route
• Support for PMDA pre-submission consultation if needed

Contact us for a free classification assessment →