License maintenance is an important consideration for manufacturers selling medical devices in the Philippines as failures to comply could lead to loss of market access and significantly affect sales. License Maintenance in the Philippines consists of paying an Annual Retention Fee, maintaining advertising compliance and obtaining approval prior to importing products that have changed from the original Registration Certificate.
The FDA does permit License Variations and are typically approved within 3 months.
Permitted Variations include:
Change of legal manufacturer, exporter, and manufacturer
Change of importer of distributor
Change of manufacturer, importer, or distributor’s addresses
Change and/or addition of sterilization site
Change of label design
Some changes of Instructions for Use (IFU)
Annual Retention Fees and Additional Requirements
The Philippines FDA now requires annual retention fees and will be due on the anniversary of the approval date.
The FDA may also include additional stipulations when approving a product, including restrictions on where a product is sold and information that needs to be on the labeling.
Changes – Interpretations of permissible modifications can vary and it’s important to always check with your License Holder or Regulatory Professionals when considering new changes to maintain compliance and avoid losing market access.
Contact Asia Actual with any medical device license amendment questions in the Philippines. Our local, bi-lingual regulatory experts are well positioned to assist.