Medical Device Approval Philippines

The Philippines medical device market is valued at US $300 million with a growth rate of 9% CAGR. Majority of the patients are form the private healthcare sector. The government has enforced the FDA Act of 2009 to strengthen the regulations of medical products in the Philippines.

There are two key documents that are required for registration:

  1. License To Operate (LTO)
  2. Product Registration

1. License to Operate (LTO)

Any establishment in the Philippines from single proprietorship to public and private limited companies can apply for the LTO as long as they are engaged in the healthcare field as importers/ distributors/wholesalers/manufacturers/traders etc.

The documents required to get an LTO for a medical device importer / distributor are:

  • Business Registration Certificate
  • Location Plan
  • Contract of lease of Space
  • Pharmacist Information
  • Product Listing
  • Floor Plan
  • Agreement with Medical Device Manufacturer for Distribution

Time frame to obtain the LTO is between 1 – 3 months.

2. Product Registration

A company that has a LTO can apply for the registration certificate. Philippines FDA classifies instruments, apparatus, machines, appliances, implants, in-vitro diagnostics, software and any material or article which is used in the diagnosis, prevention, monitoring, treatment or alleviation of diseases and does not achieve its primary function in or on the human body by pharmacological, immunological or metabolic means.

The classification of medical devices in the Philippines is of two types:

  • Registerable
  • Non- Registerable – A Certificate of Exemption will be issued by the CDRRHR for non-registerable devices after the evaluation of your documents.

Key Documents required to get the medical device registration certificate in the Philippines:

  • ISO 13485
  • Free Sale Certificate from Country of Origin
  • Device description, features, indications
  • Instructions for Use
  • Pre-clinical Studies
  • Clinical Studies
  • Shelf Life and Biocompatibility
  • Label
  • Risk Analysis
  • Manufacturing Process

Time taken to obtain approval on submission of dossier is 6-9 months with a validity of 1 or 5 years.

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