Quality System Overview
CDRRHR · DOH AO 2018-0002 · ISO 13485 · GDP
Who Needs a QMS
All entities involved in the Philippines medical device supply chain are expected to operate quality and distribution management systems:
| Entity | QMS Requirement |
|---|---|
| Foreign manufacturer (Class B/C/D) | ISO 13485 certification — mandatory for CMDR |
| Foreign manufacturer (Class A) | QMS recommended; ISO 13485 not mandated at CMDN stage |
| Local importer / distributor | GDP-aligned quality system for storage and distribution |
| Local manufacturer | ISO 13485 or equivalent QMS; GMP compliance expected |
ISO 13485 — Core QMS Standard
ISO 13485 is the internationally recognised QMS standard for medical device manufacturers. For Class B/C/D CMDR applications, an ISO 13485 certificate is mandatory.
Requirements:
- Certificate must be issued by an internationally accredited certification body (accredited by a member of the International Accreditation Forum — IAF)
- Certificate must cover the relevant product scope (the certified scope must include the device type being registered)
- Certificate must be current at time of CMDR submission and throughout the registration validity period
- An expired or suspended certificate must be replaced with a current one before renewal
See ISO 13485 Requirements for detail on what the standard covers and how to maintain compliance.
Key QMS Elements — Philippines Requirements
Regardless of whether ISO 13485 is formally required, all entities are expected to have systems covering:
| QMS Element | Applies To |
|---|---|
| Risk Management Plan (RMP) | All entities |
| Standard Operating Procedures (SOPs) | All entities |
| Good Storage and Distribution practices | Importers / distributors |
| Complaint handling system | All entities |
| Product recall procedures | All entities |
| Medical device disposal / destruction procedures | Importers / distributors |
| Document and record control | All entities |
These elements are reviewed by CDRRHR during inspections of licensed establishments.
GDP — Good Distribution Practice
Good Distribution Practice for Medical Devices (GDPMD) is not yet formally mandated as a standalone requirement in the Philippines, but CDRRHR expects importers and distributors to maintain distribution quality systems covering:
- Appropriate storage conditions (temperature, humidity, handling)
- Segregation of quarantined, approved, and rejected stock
- Traceability of received and distributed products
- Chain-of-custody documentation for each device
GDPMD is expected to become a formal regulatory requirement. Monitor CDRRHR circulars for implementation dates.
QMS for the LTO
The License to Operate (LTO) is a pre-condition for all CMDN/CMDR applications. As part of the LTO application, the establishment must demonstrate it has systems in place for:
- Receiving, storing, and distributing devices under controlled conditions
- Complaint handling and adverse event reporting
- Recall management
See LTO Requirements.
Post-Registration QMS Maintenance
Once a CMDN or CMDR is issued, the license holder must:
- Maintain the ISO 13485 certificate in scope and valid throughout the registration period
- Provide updated certificates at renewal
- Notify CDRRHR if the manufacturer's ISO 13485 certification is suspended or withdrawn
- Ensure the manufacturer's QMS continues to cover the registered product
Loss of ISO 13485 certification by the manufacturer during the registration period is a material change that must be reported and may lead to suspension of the CMDN/CMDR.