License to Operate (LTO)
PH-Unique · Mandatory for all device operators · CDRRHR / FDA Philippines
What Is the LTO?
The License to Operate (LTO) is a mandatory FDA Philippines licence that every entity operating in the medical device supply chain must hold before any product registration can be applied for or any commercial activity can begin.
The LTO confirms that the entity meets the operational, quality, and facility requirements to handle medical devices in the Philippines.
Who Must Hold an LTO?
| Entity Type | LTO Required |
|---|---|
| Philippines manufacturer of any medical device | ✅ Yes |
| Commercial importer of any medical device | ✅ Yes |
| Wholesale distributor | ✅ Yes |
| Retail distributor (in most cases) | ✅ Yes |
| Trader / re-packer | ✅ Yes |
| Entity holding CMDN/CMDR certificate | ✅ Yes |
| IVD importer / distributor | ✅ Yes (even though IVDs don't require CMDN/CMDR) |
A CMDN or CMDR application cannot be submitted without a valid LTO.
LTO Application Requirements
Submit to CDRRHR / FDA Philippines:
| Document | Detail |
|---|---|
| Application form | FDA Philippines LTO application form |
| SEC / DTI registration | Proof of Philippines business registration |
| Mayor's permit / business permit | Local government business permit |
| Tax identification documents | BIR registration |
| Facility details | Address, floor plan, storage capacity, conditions |
| Responsible person details | Name, qualifications |
| List of products/activities | Categories of devices to be handled |
Facility Requirements
The LTO applicant's facility must meet standards for:
- Storage conditions: Temperature, humidity, and light conditions appropriate for the device categories handled
- Cold chain: For temperature-sensitive devices
- Security: Controlled access to prevent theft or tampering
- Cleanliness: Clean, orderly facility
LTO Categories
LTO categories correspond to activities:
| Category | Activity |
|---|---|
| Manufacturer | Manufacturing devices in Philippines |
| Importer | Commercial importation into Philippines |
| Wholesaler | Distribution to other regulated entities |
| Retailer | Distribution directly to end users |
| Trader | Buying and selling without direct importation |
| Re-packer | Repackaging of registered devices |
An entity may hold LTOs in multiple categories.
Product Classification Inquiry Process — PH-Unique
A distinctive CDRRHR service is the formal product classification inquiry process, enabling manufacturers and importers to obtain a written CDRRHR determination on:
- Whether a product is a medical device
- What class it should be assigned
- Whether CMDN or CMDR is required
How to Submit a Classification Inquiry
- Prepare a written inquiry letter with: full product description, intended purpose, materials, manufacturer details
- Submit to CDRRHR at FDA Philippines (in person, or check for online submission option)
- Food and Drug Action Center — walk-in assistance available for classification queries
- Receive written classification determination from CDRRHR
Always obtain a classification determination before investing in full registration preparation for borderline or uncertain products.
LTO Renewal and Maintenance
LTOs are valid for a defined period and must be renewed. Key points:
- Submit renewal application before expiry — a lapsed LTO invalidates the ability to submit new registration applications
- Notify CDRRHR of significant changes to the facility or operations
- Keep the LTO renewal in sync with CMDN/CMDR renewal planning
One-Time Compliance Period — 90-Day Rule — PH-Unique
Both LTO and product registration applications are subject to the one-time compliance period:
- If CDRRHR identifies deficiencies, the applicant has 90 calendar days to submit a complete response
- The 90-day period is a single opportunity — partial responses do not restart the clock for unaddressed items
- If no response or incomplete response within 90 days: application is deemed abandoned
Plan your compliance responses carefully. Address all deficiency items completely in one comprehensive response package.