The Department of Health of the Republic of the Philippines has released a proposed Administrative Order, which aims to establish Good Manufacturing Practice (GMP) guidelines for local manufacturers of medical devices, including in vitro diagnostic (IVD) medical devices, to ensure that medical devices are manufactured in accordance with applicable quality standards.
Scope of the Proposed Guidelines
The proposed Order will apply to all local manufacturers of medical devices, including IVD medical devices. Packers, repackers, refurbishers, and toll manufacturers will also be considered manufacturers and will therefore be covered by the Order. However, although traders are categorized as manufacturers, traders of medical devices, including IVD medical devices, are excluded from the scope of the Order.
Adoption of PNS ISO 13485:2019 as the FDA GMP Guideline
One of the key provisions of the proposed Order is the adoption of Philippine National Standard (PNS) ISO 13485:2019 as the Philippine Food and Drug Administration (FDA)’s official guideline for the conduct of GMP.
Under the proposed guidelines, all local manufacturers of medical devices, including IVD medical devices, will be required to adhere to the relevant provisions of PNS ISO 13485:2019.
Requirements for Clean Rooms
Local manufacturers whose manufacturing activities require clean rooms will also be required to comply with the relevant provisions of the PNS ISO 14644 series adopted under the proposed Order.
The draft specifically identifies the following standards:
- PNS ISO 14644-1:2019 – Cleanrooms and associated controlled environments – Part 1: Classification of air cleanliness by particle concentration
- PNS ISO 14644-2:2019 – Cleanrooms and associated controlled environments – Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
- PNS ISO 14644-3:2021 – Cleanrooms and associated controlled environments – Part 3: Test methods
- PNS ISO 14644-5:2021 – Cleanrooms and associated controlled environment – Part 5: Operations
Any amendments and supplements to PNS ISO 13485:2019 and the PNS ISO 14644 series listed above will also be automatically adopted.
Compliance with PNS ISO 13485:2019 and, where applicable, the relevant parts of the adopted PNS ISO 14644 series will be verified during FDA-GMP-related inspections. The guidelines for the conduct of FDA-GMP inspections and the issuance of GMP certificates will be provided under a separate FDA issuance.
Accordingly, all local manufacturers will be required to secure a copy of PNS ISO 13485:2019 and, where applicable, the relevant parts of the PNS ISO 14644 series.
Two-Year Transitory Period
Upon effectivity of the proposed Order, local manufacturers of medical devices and IVD medical devices will be given a two-year transitory period to comply with the new GMP guidelines.
During this period, local manufacturers may continue applying their existing GMP standards for GMP inspections and GMP certificate applications. After the transitory period, compliance with the guidelines established under the Order will be required.
Key Takeaway
The proposed Administrative Order introduces a more standardized GMP framework for local medical device manufacturers through the adoption of PNS ISO 13485:2019 and applicable PNS ISO 14644 standards. Local manufacturers should assess their current GMP practices against the proposed requirements and prepare for compliance within the two-year transitory period once the Order takes effect.
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Reference
Draft Administrative Order – Guidelines on Good Manufacturing Practices (GMP) for Medical Devices