No.1
The Philippines meets RWLIANCE ROUTED MOUXIE Category B and C medical devices
On September 27, 2022, the Philippine Food and Drug Administration issued Circular No. 2022-008 announcing that Class B, C, and D medical devices approved by members of the Association of Southeast Asian Nations will be eligible for Reliance Route registration, thus expediting review and accelerating market access. Asean members include Singapore, Thailand, Vietnam, Indonesia, Brunei, Cambodia, Laos, Malaysia, Myanmar and the Philippines.
As stated in AO 2018-0002, these products are currently required to be approved by the manufacturer of the medical device Registration certificate for use in the ASEAN reference countries using the Common Submission Document (CSDT). In addition, the manufacturer must prove that the device itself is consistent with the documents previously submitted, otherwise it will not be eligible for registration with the Philippine Food and Drug Administration.
The extension of all equipment review processes will allow thirty business days after receipt of proof of payment from the Center for Equipment Regulation and Radiological Health and Research (CDRRHR). This significantly reduces the previous review time of one hundred and eighty (180) business days or more.
No.2
How to use RELIANCE ROUTE
When submitting technical documentation required by the Philippine Food and Drug Administration, the applicant must work with an authorized representative in the Philippines to submit the appropriate documentation. These documents include:
The technical documents to be prepared in the Common Submission Template (CSDT) format for the ASEAN reference country’s product registration certificate, compliance assessment, certification product details, all technical requirements and labelling materials are exactly the same as those submitted in the ASEAN reference country.
If these guidelines are not properly followed and the product details are not changed with authorization, the applicant must voluntarily recall the product from the market and indemnify the FDA against third-party claims for discrepancies in the product details.
While the Philippine Food and Drug Administration will strictly review and enforce these regulations, it aims to provide more rapid review and easier market access for medical devices in the Philippines.
No.3
Philippines fast entry to market choice
Manufacturers who wish to take advantage of this new Reliance route offer many different options depending on their regional strategy. Although many manufacturers will register in Singapore, if the Philippines is a key market and speeding up market access is a priority, it is better to register in Indonesia or Vietnam first so that their Reliance route application can be submitted to the Philippines in one or two months, saving up to six months.
Manufacturers looking for quick access to the Philippine market can also leverage through the new Reliance route from the following options:
①．Indonesia is currently the best choice for all products, as devices approved by the Indonesian Ministry of Health are approved for reference country Class B and C within 30 days and Class D within 45 days.
②. Singapore: Instant Registration Route:
Category B products with 2 reference country approvals or 1 reference country approval and 3 years of safety marketing history will be immediately approved by the Singapore HSA.
Very few Category B products in the Philippines currently require CMDR.
Vietnam approves Category A and B products within 5 days, while Category C and D products should be approved by the reference country within 30 days. However, Vietnam’s Ministry of Health has not issued any C or D market authorization licenses since the implementation of the new regulations on January 1, 2022.
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Post time: Jun-16-2023