The Philippine Food and Drug Administration (FDA) has released a draft circular proposing the adoption of Philippine National Standard (PNS) ISO 13485:2019 as the official Good Manufacturing Practices (GMP) guideline for medical device and in-vitro diagnostic (IVD) manufacturing establishments in the Philippines.
The proposed requirements would apply to manufacturers, packers, repackers, refurbishers, toll manufacturers, and other covered establishments engaged in medical device manufacturing.
Traders are excluded from the scope of the draft.
The draft aims to align local GMP requirements with internationally recognized medical device quality management standards and proposes a two-year transition period from the circular’s effectivity to allow covered establishments to comply with the new requirements.
Read the draft circular here:
Adoption of Good Manufacturing Practices (GMP)
Guidelines for Medical Devices Under the Philippine National Standard (PNS) ISO 13485:2019 [PDF]
Purpose of the Draft Circular
To propose the adoption of PNS ISO 13485:2019 as the GMP guideline for medical device and IVD manufacturing establishments in the Philippines.
The draft also aims to provide a transition period for covered establishments to align their quality management systems with the proposed requirements.
Scope of Application
The proposed requirements would apply to covered medical device manufacturing establishments, including:
- Manufacturers
- Packers
- Repackers
- Refurbishers
- Toll manufacturers
- Other covered establishments engaged in medical device manufacturing
Traders are excluded from the scope of this draft circular.
Key Updates
1. Proposed Adoption of PNS ISO 13485:2019
The FDA proposes adopting PNS ISO 13485:2019 as the official GMP guideline for medical device and IVD manufacturing establishments.
The proposed framework would align local GMP expectations with internationally recognized medical device quality management system requirements.
2. GMP Compliance to Be Assessed During FDA Inspections
Compliance with the proposed GMP requirements would be assessed during FDA GMP-related inspections.
Covered establishments would therefore be expected to demonstrate that their quality management systems and manufacturing controls comply with the applicable requirements once the circular becomes effective.
3. Proposed Two-Year Transition Period
The draft proposes a two-year transition period from the date of effectivity.
This transition period is intended to allow covered establishments time to align their existing systems and processes with the proposed GMP requirements.
Public Consultation
Stakeholders may submit comments and recommendations on the draft using the prescribed commenting template.
Submission deadline: 11 November 2026
Comments should be submitted to:
Commenting template:
Companies affected by the proposed requirements may wish to review the draft and provide feedback where clarification or industry input may be beneficial.
Implications to Clients
Covered establishments should consider reviewing their existing quality management systems against the proposed ISO 13485 requirements.
Areas for review may include:
- Quality management system documentation
- Process controls
- Validation activities
- Traceability procedures
- Complaint handling
- Corrective and Preventive Action (CAPA) processes
Companies are also encouraged to review the draft carefully and submit comments to the FDA before the consultation deadline where appropriate.
As the circular remains in draft form, organizations should not implement changes solely on the basis of the proposed requirements until the final circular has been issued.
Proposed Effective Date
The effective date has not yet been established.
The draft proposes that the circular would take effect 15 days after publication and filing with the University of the Philippines Law Center’s Office of the National Administrative Register (ONAR).
A two-year transition period would then apply from the date of effectivity.
For Inquiries
For inquiries or support regarding medical device regulatory requirements in the Philippines, please contact sales@andamanmed.com.