Philippines IVD Registration: Separate Pathway, Risk Tiers and NRL

1. Key takeaways

In vitro diagnostic devices are expressly excluded from the scope of AO No. 2018-0002 by Section III of that order. As a result, IVDs do not use the CMDN or CMDR system. They follow a separate pathway, in which the CPR, or Certificate of Product Registration, is the certificate type generally used in practice, while the dedicated CIVDN and CIVDR system continues to evolve. IVDs are also graded A to D, and some products must complete a performance evaluation at the National Reference Laboratory (NRL).

The practical consequence is that an IVD programme cannot be planned by adapting a device programme. The dossier content is different, the reviewer is examining analytical and clinical performance rather than general safety and performance, and the fast-track mechanism available to devices is closed. Each of these differences changes the schedule, and a plan built on device assumptions typically understates the timeline by the whole of the NRL block.

• IVDs are outside AO No. 2018-0002 by Section III and are governed by separate rules.
• CPR is the certificate type used in current practice; the CIVDN and CIVDR system remains under development.
• IVDs are graded A to D on intended use and risk.
• Selected IVDs must complete performance evaluation at the National Reference Laboratory.
• The abridged fast track in FC No. 2022-008 does not apply to IVDs, even where another ASEAN authority has cleared the product.

2. Legal basis

Two provisions define the position. Section III of AO No. 2018-0002 removes IVDs and refurbished devices from the general device rules and states that separate administrative orders govern them. Section III of FC No. 2022-008 removes the same two categories from the abridged pathway. The definition of an IVD in AO No. 2018-0002 Section IV, item 11 is what determines whether a product is caught by these exclusions at all.

3. Expert insights

Insight one: exclusion does not mean absence of regulation, it means a different rule set.

AO 2018-0002 excludes IVDs and refurbished devices because both product families carry separate technical requirements and review logic within the ASEAN system. IVDs are assessed on analytical and clinical performance, refurbished devices on remanufacturing and equivalence. Neither fits comfortably into a common CSDT template built around general device safety. The result is that IVD manufacturers cannot reuse device filing experience as a template. The working assumption should be that the file is being built for a different reviewer with a different checklist.

Insight two: the exclusion from the ASEAN reliance fast track is a hard constraint in planning.

Section III of FC No. 2022-008 states plainly that the Circular does not apply to IVDs or refurbished devices. This means that even where an IVD has been approved by the HSA in Singapore or the MDA in Malaysia, that approval cannot be used to enter the 30 working day abridged pathway. The restriction is rarely mentioned in Chinese-language material, yet it is the key variable in any IVD timeline estimate, because it removes the single mechanism that most compresses review time for device submissions.

Insight three: NRL performance evaluation is the block most often left out of the schedule.

Certain IVDs, including pregnancy test reagents and infectious disease test reagents, must complete performance evaluation at the Philippine National Reference Laboratory. That step sits outside technical review and adds time of its own. Our practice is to run the NRL step in parallel with dossier preparation rather than waiting for an FDA notification to start it, because the laboratory slot is the least flexible element in the chain and cannot be accelerated by better paperwork.

Insight four: IVD risk logic differs because indirect harm counts as harm.

The risk of an IVD does not arise only from the device itself but also from the delay or the wrong treatment that follows an incorrect reading. This matters particularly in post-market vigilance. Under the AO No. 2025-0030 framework, indirect harm caused by an IVD is an expressly reportable adverse event. The general device vigilance system has no direct equivalent, so an IVD manufacturer needs its own reporting criteria rather than a borrowed device procedure.

4. Practical recommendations

• Confirm the current pathway with CDRRHR before filing. Because the dedicated IVD order is still evolving, CPR and CIVDR terminology coexist in practice. We recommend a written confirmation of the applicable pathway and document list before the project starts, rather than relying on lists circulating online.
• Move NRL testing to the front. Determine early whether the product falls into a category requiring NRL evaluation. If it does, book the sample submission during dossier preparation so that the laboratory step overlaps with document work.
• Do not schedule an IVD on a fast-track assumption. Build the timeline on standard review duration. The reliance pathway is unavailable, and a plan that assumes it will slip at the point where the submission meets the queue.

5. Verification checklist

• □ Confirm that the product meets the IVD definition in AO No. 2018-0002, Section IV, item 11.
• □ Confirm the applicable pathway in writing with CDRRHR, including whether the current certificate type is CPR or CIVDR.
• □ Confirm the risk grade under the IVD grading rules, A to D.
• □ Confirm whether NRL performance evaluation is required for the product category, with the FDA.
• □ Confirm that the abridged route is unavailable, per Section III of FC No. 2022-008.
• □ Confirm the vigilance position: IVD indirect harm is a reportable event under the AO No. 2025-0030 framework.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including the Philippines. Our team prepares CMDN/CMDR dossiers to ASEAN CSDT structure, manages submissions and deficiency responses with the FDA Philippines, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com