Pre-Market Overview

CDRRHR · DOH AO 2018-0002 · ASEAN AMDD · CMDN / CMDR

Choosing the Right Pathway

Pre-market market access in the Philippines follows a risk-class-based dual-certificate model:

Device Class	Risk Level	Certificate	Route
Class A	Low	CMDN — Certificate of Medical Device Notification	Notification
Class B	Low-moderate	CMDR — Certificate of Medical Device Registration	Full registration
Class C	Moderate-high	CMDR	Full registration
Class D	High	CMDR	Full registration

Both CMDN and CMDR are valid for 5 years and must be renewed before expiry.

Pre-Market Checklist — All Classes

Before submitting any application, ensure:

• Device is correctly classified under ASEAN AMDD rules — see Classification
• Applicant holds a valid License to Operate (LTO) — see LTO
• Technical documentation is prepared in the correct format (CSDT for Class B/C/D)
• Clinical/performance evidence meets the class-specific threshold
• Philippines-compliant labelling is ready
• QMS evidence (ISO 13485 certificate) is current — Class B/C/D

Abridged (Reliance) Pathway

For Class B/C/D devices already approved by an ASEAN National Regulatory Authority (NRA), an expedited pathway is available under FDA Circular 2022-008:

• Target review time: 30 working days
• Requires CSDT documents used in the reference NRA submission
• See Abridged Pathway

eServices Portal

FDA Philippines processes CMDN and CMDR applications through the FDA eServices Portal. Account registration and document upload are completed online. See eServices Portal.

Section Guide

Section	Content
Classification	Class A–D rules, ASEAN AMDD, IVD status
CMDN — Class A	Notification process, required documents
CMDR — Class B/C/D	Full registration, CSDT, review process
Abridged Pathway	30-day reliance route via ASEAN NRA
Technical Documentation	CSDT structure, dossier requirements
Clinical Evidence	Requirements by device class
Special Device Types	SAMD, combination products, IVDs