ISO 13485 Requirements

Class B/C/D mandatory · CDRRHR · CMDR prerequisite

What Is ISO 13485

ISO 13485:2016 is the international standard for quality management systems specific to the medical device industry. It is mandatory evidence for all Class B, C, and D CMDR applications in the Philippines — the manufacturer's ISO 13485 certificate is submitted in Section 9 of the ASEAN CSDT.

Certificate Requirements

Requirement	Detail
Issuing body	Accredited by an IAF (International Accreditation Forum) member body
Scope	Must cover the specific device type / product category being registered
Status	Must be current — not expired, suspended, or withdrawn
Language	English or with certified translation

What ISO 13485 Covers

The standard requires documented processes across the device lifecycle:

Area	Key Requirements
Management responsibility	Quality policy, quality objectives, management review
Resource management	Competence, training, infrastructure, work environment
Product realisation	Design controls, purchasing controls, production and process controls
Design and development	Planning, inputs, outputs, review, verification, validation, changes
Purchasing controls	Supplier evaluation, verification of purchased products
Production controls	Process validation (for sterile / implantable devices), identification and traceability
Monitoring and measurement	Feedback, complaint handling, reporting to authorities, internal audit, CAPA
Analysis and improvement	CAPA system, preventive action

Sterile and Implantable Device Additional Requirements

ISO 13485 includes specific additional requirements for:

• Sterile devices: Sterilisation process validation and revalidation; records of sterilisation parameters for each batch
• Implantable devices: Unique device identification and traceability to component level; enhanced inspection and testing records
• Software: Software development life cycle documented per IEC 62304 where applicable

Certification Process

Manufacturers achieve ISO 13485 certification through a third-party audit by an accredited certification body:

1. Stage 1 audit — documentation review and readiness assessment
2. Stage 2 audit — on-site assessment of QMS implementation
3. Certification decision and certificate issuance
4. Surveillance audits — typically annually
5. Recertification audit — every 3 years

Maintaining Certification

The QMS certificate must remain valid throughout the CMDN/CMDR validity period:

• Monitor certificate expiry date and plan recertification well in advance
• Surveillance audit non-conformances must be resolved; major non-conformances may lead to certificate suspension
• Any change in certification body must be managed to avoid a gap in valid certification
• Updated certificates must be submitted at CMDN/CMDR renewal

When Certification Is Suspended or Withdrawn

If the manufacturer's ISO 13485 certificate is suspended or withdrawn:

• The CDRRHR must be notified promptly
• The CMDN/CMDR may be suspended pending restoration of certification
• The license holder must work with the manufacturer to resolve the non-conformances and restore certification
• Do not allow the certificate to lapse without a plan — gaps create regulatory risk for the Philippines registration