Elevate your medical device business in the Philippines with ISO 13485 certification

Gearing up to launch a new medical device product? You know that quality, regulatory compliance, and market trust are key. What if there is a proven framework that ties all these together? Well, ISO 13485 certification is the solution to your query…

 

ISO 13485 certification stands for…

ISO 13485:2016 certification is a worldwide standard for quality management systems, specifically for medical devices. It creates a system for designing, making, storing, and keeping up products that meet what customers need and follow the rules

In the Philippines, more companies are getting this certification to stay competitive and meet international standards.

Why do medical device companies in the Philippines bother with this certification?

Well, customers and regulators prefer companies that have ISO 13485 certification. It gives them an advantage. Businesses need ISO 13485 to be part of programs like the Medical Device Single Audit Program or to get the UK Conformity Assessed mark. for manufacturers who want to export and follow global regulations.

 

The ISO 13485 certification process in the Philippines

To get ISO certification, manufacturers must follow these steps: So, it’s super important

  • Check the current Quality Management System through a gap analysis to identify areas for improvement.
  • Write down and put into action procedures, policies, work instructions, and plans to manage risk. These should cover design control, traceability, and product post-sale monitoring.
  • Do an in-house check to make sure the system works well and identify any issues to fix.
  • Certification audit by an external expert through Stage 1, i.e., Documentation review and readiness assessment, and Stage 2, i.e., on-site audit to confirm operational implementation of QMS.
  • Once successful, receive the 13485 certification, which is valid for three years, subject to surveillance audits.

 

ISO 13485 risk management in the Philippines for medical devices

ISO 14971 goes hand in hand with ISO 13485 as the standard for managing risk. It’s often mentioned in ISO 13485 when it comes to identifying, assessing, and controlling hazards. A well-organized risk process makes products safer and meets the expectations of Philippine regulators.

 

Following the Philippine rules about ISO 13485 certification

Health and tech firms working in the Philippines must meet the tough standards set by the Philippine Food and Drug Administration. They also need to follow the advice from the Centre for Device Regulation, Radiation Health, and Research.

For medical devices classified under Classes B, C, and D, the submission of a Certificate of Medical Device Registration (CMDR) is mandatory, including a valid ISO 13485:2016 certificate, which supports the requirements under FDA Circulars and the ASEAN Medical Device Directive (AMDD) framework.

 

How Global Quality Services can help?

Achieving ISO 13485 certification in the Philippines is a strategic move for medical device companies seeking quality excellence and regulatory recognition. And this is where Global Quality Services comes in with proven experience in the Philippine market.

GQS provides end-to-end support, from ISO 13485 transition requirements in the Philippines and gap analysis to training, documentation, internal audit, and audit readiness. Supporting regulatory alignment and export-readiness is an addition here.

Partner with GQS to make your ISO 13485 journey compliant, efficient, and globally market-ready.