Who Needs to Comply?
Overview
All entities in the Philippines medical device supply chain must hold a License to Operate (LTO) from CDRRHR. For Class A devices, a CMDN is required. For Class B/C/D devices, a CMDR is required.
Local Manufacturers
Philippines-based manufacturers of Class A, B, C, and D devices must:
- Hold an LTO as a manufacturer
- Obtain CMDN (Class A) or CMDR (Class B/C/D) before market placement
- Comply with GMP requirements
- Maintain post-market obligations
Importers
All commercial importers of medical devices must:
- Hold an LTO as an importer
- Import only devices with valid CMDN or CMDR (non-IVD devices)
- Ensure devices comply with Philippine labelling requirements
- Maintain distribution records
Distributors, Traders and Wholesalers
Entities that distribute, trade, or wholesale medical devices must hold an LTO. The specific LTO category depends on the activity (wholesale, retail, etc.).
Re-packers
Entities that repackage registered medical devices into smaller units must hold an LTO as a re-packer. The re-packed device must retain its CMDN/CMDR validity.
Local Representative / License Holder — PH-Unique
For foreign-manufactured devices, the CDRRHR requires a local license holder — a Philippines-registered entity that holds the CMDN or CMDR:
| Obligation | Local Representative / License Holder |
|---|---|
| Holds CMDN/CMDR certificate | ✅ Yes |
| Submits registration application | ✅ Yes |
| Provides Letter of Authorization from manufacturer | ✅ Yes (notarised declaration required) |
| Post-market obligations | ✅ Yes |
| LTO as importer | ✅ Yes (or separate importer entity) |
Lifecycle of a Device in the Philippines
| Stage | Action |
|---|---|
| 1 | Classify device (ASEAN AMDD Class A/B/C/D) |
| 2 | Confirm not an IVD (currently exempt) or check current IVD status |
| 3 | Obtain LTO (manufacturer / importer / distributor as applicable) |
| 4 | Prepare CMDN application (Class A) or CMDR application (Class B/C/D) |
| 5 | Submit to CDRRHR |
| 6 | Address deficiencies within 90 calendar days if raised |
| 7 | CMDN / CMDR certificate issued |
| 8 | Commercial distribution |
| 9 | Post-market: vigilance, eReport system, maintenance |
| 10 | Certificate renewal before expiry |