Fees increase after years in Singapore HSA & Philippines FDA, and yearly approach increase by US


Singapore

The Health Sciences Authority (HSA) regulates health products to ensure that they meet the required standards of quality, safety and efficacy. There are fees in place to help cover the cost of registration, licensing, notification and permit issuance for therapeutic products, medical devices, Chinese proprietary medicines, cosmetic products, oral dental gums and retail pharmacies.

The majority of these fees have remained unchanged since 2006. With rising operating costs over the last decade, there will be a need to adjust the fees to cover part of the costs for the services rendered.

The fee increase averaging 3% will be implemented from 2 April 2019. A minimum increase of $1 applies for low fee items. For fee items requiring more complex regulatory review and work, the increase will be capped at $200 to minimise the impact on industry stakeholders.

For more information on revised fees, click here.

Philippines

Fees will be implemented targeted in end of year 2019.

The proposed fees are a significant increase and have impacted the local industry and overseas manufacturers penetrating the Philippines market.

For more information on revised fees, click here.

The fees are also in preparation for the recent news on the phase control of medical device. All currently registrable products for Classes B-D must be submitted by March 31, 2019, when Administrative Order (AO) 2018-0002 comes into force.

For more information on AO 2018-0002, click here.

United States

US Food Drug Administration (FDA) announces increased user fee rates and adjusted payment procedures for medical devices for the new fiscal year (FY) 2019. New fiscal year applies from October 1, 2018 through September 30, 2019. Adjusted rates to adjust for inflation and FY2019 revenue target of US$204m.

Revised fees information can be found here.

Australia

On 7 June 2018, the Australian Government approved an increase of 1.9 % to most TGA fees and charges. 2018 was also the year which shocked sponsors of Class I medical devices whereby the TGA introduced the introduction of an application fee of $530 for inclusion of Class I medical devices.

The revised fees and charges were in effect from 1 July 2018.

Schedule of fees and charges can be found here.

Contact us at info@arqon.com.


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