Philippines FDA, Introduction of Updated Regulations for Health Product Establishments

 

On November 27, 2024, the Philippine Food and Drug Administration (FDA) issued Administrative Order No. 2024-0015, introducing updated regulation on the License to Operate (LTO) requirements for health product facilities.

 

This administrative order sets forth the updated rules, requirements, and procedures for the initial, renewal and change of the LTO application through the FDA eServices Portal System.

 

The scope of the regulations includes manufacturers (packaging, repacking, and reprocessing companies), traders, distributors (importers, exporters, and wholesalers), and others. The regulations pertaining to medical device facilities are as follows.

 

1. For Medical Device establishments

 The following establishments are considered medical device manufactures and must apply for and maintain a License to Operate (LTO):

 - All hospitals and establishments engaged in the 3D printing of medical devices

 - Optical establishments engaged in the assembly of optical lenses and frames; and

 - Dental laboratories engage in the manufacture of custom-made dental devices

 

2. Application for License to Operate (LTO)

 - The application for an LTO for medical device manufacturers includes initial, renewal, and change applications. The application, along with the required documents, must be submitted through the FDA eServices System.

 

3. Regulatory Inspection

 - the FDA has the right to inspect all documents, equipment, finished products or components, materials, containers, and labels associated with approved activities for all establishments to reduce risks posed by products sold or being sold.

 

4. Renewal

 - Renewal applications must be made within 90 days prior to the expiration of the LTO.

 - If the renewal application is submitted after the expiration date (up to a maximum of 120 days), the renewal fee will be doubled, plus an additional 10% monthly late fee.

 

5. Validity of the LTO

	Micro and Small Enterprises	Medium and Large Enterprises
Initial LTO	3 years	6 years
Renewal LTO	6 years	12 years

 

Please refer to the link below. 

https://www.fda.gov.ph/administrative-order-no-2024-0015-prescribing-the-rules-requirements-and-procedures-in-the-application-for-license-to-operate-of-covered-health-product-establishments-with-the-food-and-drug-adm/

 

 

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