How to Use the ASEAN Reliance Pathway: FC 2022-008 and Its 30-Working-Day Mechanism

1. Key takeaways

Yes, it is available. Under FDA Circular No. 2022-008 (FC No. 2022-008) of 27 September 2022, a Class B, Class C or Class D medical device that has already been approved for marketing by the national regulatory authority of any ASEAN member state, against the AMDD-CSDT requirements, may use Abridged Processing in the Philippines, with a target review period of about 30 working days. The pathway is not available to IVDs or refurbished devices, and it is not available to products whose only basis is an abbreviated approval granted outside ASEAN.

• The pathway is a reliance mechanism, not an automatic recognition mechanism: the FDA keeps its own decision-making power and may still request additional information or refuse the application.
• Two conditions must be met together: an approval by an ASEAN member state NRA, and that approval having been made against the AMDD-CSDT requirements.
• A US 510(k) clearance or an EU CE certificate does not create eligibility on its own. This is the most common misunderstanding in Chinese-language material on the subject.
• IVDs and refurbished devices are expressly excluded, consistent with the exclusions in AO No. 2018-0002, Section III.
• The pathway is worth planning around strategically: one CSDT, properly sequenced across markets, can shorten the Philippine review phase to roughly 30 working days.

2. Legal basis

The instrument is FDA Circular No. 2022-008, issued on 27 September 2022 under the full title Abridged Processing of Application for Registration of Medical Devices Approved by the National Regulatory Authority of Any ASEAN Member Country. Its parent laws are RA No. 9711 and RA No. 11032, the Ease of Doing Business Act of 2018, and it operates on top of AO No. 2018-0002 of 26 January 2018. Section III sets the scope: Class B, C and D devices that already hold a product approval issued by an ASEAN member state NRA against AMDD-CSDT requirements. The same section excludes IVDs and refurbished devices, and CPRs resting on abbreviated approvals from non-ASEAN countries do not qualify. The legal rationale is the WHO Good Reliance Practices framework, Annex 10 to the 55th report of the WHO Expert Committee.

3. Expert insights

Reliance is not the same as automatic acceptance, and the FDA retains independent judgement. The definition in FC No. 2022-008 is precise: a regulatory authority in one jurisdiction, when reaching its own decision, refers to and gives weight to the assessment carried out by another authority or trusted institution, while the relying authority remains independent, responsible and accountable for its own decision. In practical terms, an approval elsewhere in ASEAN does not bind the FDA. It may still ask for additional information, and it may still refuse the application. Teams that read the pathway as a rubber stamp are usually the ones that receive a deficiency notice.

There are two eligibility thresholds, and both have to be satisfied. The first is that the product has been approved by an ASEAN member state NRA, meaning the regulator of a country inside ASEAN such as Singapore HSA, Malaysia MDA, Thailand FDA, Indonesia Kemenkes or Vietnam MOH. The second is that the approval was made against AMDD-CSDT requirements. Holding a US FDA 510(k) clearance or an EU CE certificate does not establish eligibility for the Abridged pathway. Those certificates are useful evidence in other contexts, but they are not an ASEAN NRA approval and they are not issued against the AMDD-CSDT.

IVDs are expressly excluded, and for IVD programmes this is a hard constraint. Section III of FC No. 2022-008 excludes both IVDs and refurbished devices, which keeps it consistent with the exclusions in Section III of AO No. 2018-0002. An IVD programme should therefore not be scheduled against a 30 working day review assumption. The planning baseline for IVDs remains the ordinary CMDR route, and an IVD programme should be scheduled against that route rather than against the fast track.

The pathway is the institutional basis for a one CSDT, many markets strategy. Its real value appears when a company is entering several Southeast Asian markets. By sequencing filings and reusing the same CSDT, the Philippines can be positioned as a follow-on market rather than a first market. GRZAN’s recommended order is to obtain approval first in a market with strong review capability and high recognition, such as Singapore, using a complete CSDT, and then use that approval as the basis for the Philippine fast track. One variable has to be reserved for: CSDT versions and the format expectations of each market at the time of filing may differ, so reuse does not mean copying the file unchanged.

4. Practical recommendations

• Run a three-question eligibility self-check before committing to the pathway. Has the product been approved by an ASEAN member state NRA? Was that approval based on the AMDD-CSDT? Is the product neither an IVD nor a refurbished device? Only a clean pass on all three justifies Abridged processing.
• Keep the full evidence of the foreign approval. That includes the approval certificate, the record of the CSDT version that was approved, and a statement of the approved scope covering models and indications. The approved scope has to cover the scope being filed in the Philippines.
• Manage CSDT versions deliberately. Record the version number and content used in the other market, and explain any differences when filing in the Philippines, rather than leaving the reviewer to discover them.
• Do not treat the foreign approval as a substitute for local requirements. Labelling, English-language documentation and LOA authentication still apply. Abridged processing shortens the review, it does not waive localisation.
• Document the sequencing decision. Where several ASEAN markets are planned, record why the reference market was chosen first, because that choice determines the critical path for every later filing.

5. Verification checklist

• □ Product is Class B, C or D under the AMDD classification rules.
• □ Product is not an IVD and not a refurbished device (FC No. 2022-008, Section III).
• □ An ASEAN member state NRA approval is held, with the original certificate available.
• □ The approval was granted against the AMDD-CSDT; submission records and CSDT version are retrievable.
• □ The approved scope covers the models and indications being filed in the Philippines.
• □ Target review period is confirmed as 30 working days under FC No. 2022-008.
• □ Localisation requirements are still met: English labelling and a completed LOA authentication.

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