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Expedited Market Access Now Available in Philippines
Published on: October 4th, 2022
Certain Class B, C, and D Medical Devices Eligible for Reliance Route in Philippines
On September 27th 2022, the Philippines FDA published Circular No. 2022-008 announcing that Class B, C, and D medical devices that have been already approved by a member country of the Association of Southeast Asian Nations (ASEAN) will be eligible for the Reliance registration route, allowing for a quicker review and expedited market access.
ASEAN member countries includes Singapore, Thailand, Vietnam, Indonesia, Brunei, Cambodia, Laos, Malaysia, Myanmar and the Philippines.
To qualify, the products must currently require a Certificate of Medical Device Registration (CMDR), as outlined in AO No. 2018-0002 and the manufacturer must have used the Common Submission Dossier (CSDT) for the approved application of said products in the ASEAN reference country. Additionally, the manufacturer must attest that the device itself is the same as represented in the previous documents filed, or it will not be eligible for Reliance registration with the Philippines FDA.
The expansion of the device review process will allow for a turnaround time of thirty (30) working days after receipt of proof of payment to the Center for Device Regulation, Radiation Health and Research (CDRRHR). This is a substantial decrease of the previous review time of one hundred and eighty (180) working days or more.
How to Utilize the Reliance Route
When submitting the technical and legal requirements required by the Philippines FDA, the applicant will need to work with an authorized representative in the country, such as Asia Actual, to submit proper documentation. These documents include:
- Certificate of Product Registration from ASEAN reference country,
- Compliance evaluation attesting that the product details and the technical documentation formatted to the Common Submission Dossier Template (CSDT) are both the exact same as the documents submitted in the ASEAN reference country,
- All technical requirements and labeling materials.
If these guidelines are not followed correctly and there is an unauthorized change in the product details, the applicant must voluntarily recall the product from the market as well as indemnify the FDA of responsibility from any third-party claims concerning said product detail discrepancies.
Though the Philippines FDA will be strict in auditing and enforcing these regulations, the intention is to provide a more expeditious review and easier market access for medical devices in the Philippines.
Expedited Market Access Options for the Philippines
Manufacturers wishing to utilize this new Reliance route will have a few different options available to them depending on their regional strategy. While many manufacturers typically register in Singapore, if the Philippines is a crucial market and expedited market access is the foremost priority, it may be wise to register in Indonesia or Vietnam first so their Reliance route application can be submitted in the Philippines in a month or two and save up to 6 months time.
Manufacturers seeking expedited market access to the Philippines may choose from the following options to leverage via the new Reliance route:
- Indonesia is currently the best option for all products as the Indonesian MOH approves devices with Reference country approval in thirty (30) days for Class B and C and forty-five (45) days for Class D.
- Singapore: Immediate Registration Route:
- Class B products with 2 Reference country approvals or 1 Reference country approval and 3 years of safe marketing history are immediately approved by the HSA in Singapore. Few class B products require a CMDR in the Philippines currently.
- Class C standalone mobile software applications with 1 Reference country and safe marketing history. HSA’s eligibility required are found here.
- Vietnam approves A and B products in 5 days while Class C and D should be approved in 30 days with a Reference Country approval. However, the Vietnamese MOH has yet to issue any C or D Market Authorization licenses since the new regulations were put in place on January 1, 2022. Recently, a seminar took place which outlined a plan to address the backlog. As some of Asia Actual’s clients have now received feedback on their C/D applications, it’s believed that the new plan may be to begin issuing MA licenses in Q4 of 2022.
Come Grow with Us
Asia Actual has an office in the Philippines located in Metro Manila which is staffed by experienced, bilingual regulatory and commercial professionals that will address any questions or provide support. Please contact us to explore if this new program is appropriate for your devices.
Asia Actual is a regulatory consulting company specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services.