Philippines Medical Device Registration: 20 Questions on CMDN vs CMDR, LTO, Fees and Timelines

The Philippines has more than 110 million people and imports over 90% of its medical devices, with demand still expanding as the Universal Health Care Act (RA 11223) equips primary care facilities. It is also a market where outdated assumptions are expensive: the transitional route that once let Class B/C/D devices in on a simple notification closed on 31 March 2023, and the fee schedule has been raised and then suspended again. These 20 questions summarise the current rules under RA 9711, AO 2018-0002, AO 2024-0015 and related circulars.

1. Regulatory framework (Q1-Q3)

Q1. Which authority regulates medical devices?

The Food and Drug Administration of the Philippines (FDA Philippines), specifically its Center for Device Regulation, Radiation Health and Research (CDRRHR).

Q2. Which regulations govern registration?

Q3. How are devices classified?

Into four risk classes A to D, using GHTF/AMDD rules based on intended use, invasiveness, duration of contact, whether the device is active, and whether it incorporates software. Classification drives both the certificate type and the depth of review.

2. Market access pathways (Q4-Q8)

Q4. Which certificate does each class need?

Class A requires a CMDN (Certificate of Medical Device Notification), a notification rather than an approval. Class B, C and D require a CMDR (Certificate of Medical Device Registration), which involves substantive technical review by CDRRHR.

Q5. What is the practical difference between CMDN and CMDR?

Q6. Can Class B/C/D devices still use CMDN?

No. During the transition, Class B/C/D devices not listed in FC 2020-001-A could file a CMDN as a stopgap. FC 2021-002-A ended that: acceptance of CMDN applications for Class B/C/D closed on 31 March 2023, and since 1 April 2023 all such devices must apply for CMDR. CMDNs already issued remain valid until expiry but must be converted to CMDR three months before that date. For any new Class B/C/D filing today, CMDR is the only route.

Q7. Can a Chinese manufacturer file directly with the Philippine FDA?

No. Applications must be submitted by a local entity holding a valid LTO. A foreign manufacturer must appoint a Philippine company as local authorised representative and marketing authorisation holder (MAH), which then carries registration, import and post-market vigilance responsibilities. Because the certificate is tied to that local holder, the choice of holder is the single most important commercial decision in a Philippine project: it determines distributor flexibility, transferability and control of the registration.

Q8. What is an LTO and how long is it valid?

The License to Operate is FDA’s licence for local companies manufacturing, importing, exporting or wholesale-distributing devices, and it is a precondition for CMDN/CMDR applications. Under AO 2024-0015 the validity depends on company size:

Applications go through the FDA eServices Portal with SEC/DTI registration documents, proof of premises, details of the qualified person (such as a licensed pharmacist), floor plans and product lists. Renewal should be filed within 90 days before expiry; late renewal attracts doubled fees plus monthly surcharges.

3. The dossier (Q9-Q14)

Q9. What documents does a CMDR application require?

Administrative documents: notarised application form, copy of the LTO, manufacturer letter of authorisation (LOA) and proof of payment. Technical documents: a full ASEAN CSDT dossier covering device description and intended use, essential principles checklist, risk analysis, verification and validation, biocompatibility, sterilisation where applicable, clinical evidence and English labelling.

Q10. Is home-country approval required, and is a Chinese certificate acceptable?

Yes – either the country-of-origin approval (for a Chinese manufacturer, the NMPA registration certificate, with a notarised declaration of authenticity and normally an English translation) or an approval from one of the five recognised reference markets: Australia, Canada, the EU, Japan or the United States.

On the free sale certificate: in implementing AO 2018-0002, FDA dropped the mandatory CFS in favour of a copy of the home-country registration plus a notarised authenticity declaration. A CFS can supplement the file but is no longer essential. Note that holding a US, EU, Japanese, Canadian or Australian approval supports a standard application but does not by itself trigger the fast track in Q16.

Q11. Is ISO 13485 mandatory?

Yes, for all classes A to D: the legal manufacturer and the actual production site must both be covered by ISO 13485 certification.

Q12. Are clinical data required?

Usually not in the sense of a dedicated clinical trial. Performance verification and published literature are the norm, with clinical evidence scaled to the risk class and the claims made.

Q13. What are the labelling requirements?

Labels and instructions must be in English, or English plus Filipino. Chinese-only labelling is not accepted, so artwork needs to be localised before filing rather than after.

Q14. Does the LOA need legalisation?

It needs an apostille, and this has become much simpler: the Philippines joined the Hague Convention in 2019 and China acceded with effect from November 2023, so Chinese-issued LOAs and similar documents can now be apostilled directly instead of going through consular legalisation at the Philippine embassy.

4. Timelines and fees (Q15-Q18)

Q15. How long does review take?

Q16. Is there a faster route?

Yes. FDA offers an abridged or reliance pathway for products already approved in another ASEAN member state using the ASEAN CSDT: the existing regional review is leveraged and the target timeline is about 30 working days. For companies filing across Southeast Asia, sequencing matters – a Singapore or Malaysian approval obtained first can shorten the Philippine stage considerably, using one CSDT dossier throughout.

Q17. How long are certificates valid, and how does renewal work?

Both CMDN and CMDR are valid for five years. Renewal must be filed within 90 days before expiry. Late filing is penalised under FC 2011-004 with doubled renewal fees plus monthly surcharges. A CMDR renewed more than 120 days after expiry is not accepted at all: a fresh initial application is required and sales must stop until the new certificate issues, though the original registration number can be retained on request. Under FDA Advisory No. 2026-1007, a certificate whose renewal was filed on time remains valid while FDA reviews it. Renewal submissions include post-market surveillance and adverse event summaries, so start preparation about six months ahead.

Q18. What are the official fees?

The fees are in transition and this is a genuine budgeting trap. AO 2024-0016 raised them sharply – roughly PHP 81,000 for Class A, PHP 108,000 for Class B, PHP 111,000 for Class C and PHP 117,000 for Class D, plus a 1% Legal Research Fund. That schedule is suspended: DOH Department Circular No. 2026-0329 extended the suspension by a further 120 working days from 9 June 2026, during which the old AO 50 s. 2001 rates apply, amounting to only a few thousand pesos. Do not budget from figures circulating online – rely on the Order of Payment generated by the FDA eServices Portal at the time of filing, and allow separately for local holder fees, notarisation and translation.

5. Special cases and post-market duties (Q19-Q20)

Q19. Do IVDs follow the same rules?

Not entirely – most IVDs currently do not require product registration in the Philippines. AO 2018-0002 expressly excludes IVDs and refurbished devices from its scope; IVDs have their own registration pathway (CPR) with separate A-D classification rules. Some IVDs also need performance evaluation at a National Reference Laboratory, which can add two to four months and should be planned for early. Devices intended only for research, clinical trials, exhibition or donation – not for sale – are exempt from CMDN/CMDR but still need a CMDL (Certificate of Medical Device Listing).

Q20. What obligations continue after approval?

1. Adverse event reporting to FDA for deaths, serious injuries and potential risk events;
2. Recalls and field safety corrective actions, with a traceable mechanism and retained records;
3. Change management: variations to product name, labelling, manufacturing site or manufacturer must be filed;
4. Certificate maintenance: renewal tracking for both the LTO and the CMDN/CMDR, since any lapse can take the product off the market;
5. Record keeping: import, distribution and complaint records retained for inspection.

FDA is also developing UDI traceability and strengthened post-market surveillance guidance, so obligations will tighten rather than relax.

GRZAN’s wholly owned Philippine entity, GRZAN PHILIPPINES INC., holds the local LTO and acts as an independent MAH: certificates sit with a neutral third party rather than a distributor, so manufacturers keep full freedom to appoint or change downstream dealers. Our scope covers classification, CSDT authoring and review, ISO 13485 readiness, apostille guidance, LTO processing, submission, deficiency responses, vigilance and renewals, coordinated with filings elsewhere in ASEAN.

Compiled from Philippine FDA regulations and circulars current as of October 2026. The AO 2024-0016 fee schedule is suspended at the time of writing; always confirm the amount on the Order of Payment issued at filing.