Medical device importation to the Philippines
Only registered medical devices may be imported into the Philippines, that means they must be registered with the Food and Drug Administration’s (FDA) Center for Device Regulation, Radiation, Health and Research (CDRRHR) and been issued with a Certificate of Medical Device Notification (CMDN), a Certificate of Medical Device Registration (CMDR) or a Certificate of Product Registration (CPR) unless exempted from registration (see below). All medical devices and in-vitro diagnostics that are in circulation in the Philippines as well as those that are exported are listed in the FDA Verification Portal System.
What are the requirements for importing medical devices into the Philippines?
- In order to import a medical device into the Philippines, a company must first obtain a License to Operate (LTO) as a Medical Device Distributor (MDDC); distributor status includes importers, exporters and wholesalers. The LTO can be applied for via the e-services system and once approved it will be issued by the FDA
- The importer must also hold a valid Bureau of Customs (BOC) Accreditation
- Products registration approval certificates such as Certificate of Medical Device Registration (CMDR), Certificate of Medical Device Notification (CMDN), Certificate of Product Registration (CPR) or other permits from other regulatory agency that is applicable to the medical device being imported (eg. CFCR, NTC import permit, DDB/PDEA exemption, DENR SQI clearance etc.)
- Currently, only local Filipino companies can apply for a License To Operate and BOC accreditation
- Multiple registrations of medical devices with different distributor license holders (MDDC) are allowed in the Philippines if the agreement between the manufacturer/supplier and the licensed distributor (importer/exporter/wholesaler) is non-exclusive
- The appointment of a distributor (importer/exporter/wholesaler) is carried out by issuing a notarized/authenticated/apostilled Distributorship Agreement or Letter of Authorization (LoA) by the foreign manufacturer
- The length of validity of the LoA depends on the manufacturer but usually validity is given for 5 years. A revalidated notarized/authenticated/apostilled LoA shall be issued again 3 months before expiry. Hence, if a distributor (importer/exporter/wholesaler) insists on exclusivity you could be locked into a 5-year contract. Therefore, it can prove judicious to appoint an independent local authorized representative to register and import your medical device giving you freedom in your distribution strategy; you may even appoint multiple distributors.
Are there any exemptions or exclusions?
- Certain products may be imported using Special Access Routes (see below).
Special Access Routes for importing medical devices into the Philippines
Special cases where special permits/certifications/exemptions are issued for unregistered medical devices:
- Certificate of Medical Device Listing (CMDL)
- Compassionate Special Permit (CSP)
- Emergency use such as during the COVID-10 pandemic:
- Special Certification for In-vitro diagnostic test kits for Covid-19 (FDA Memorandum 2020-006) currently applicable
Importer's duties and obligations
It is mandatory for importers of medical devices and IVDs to the Philippines to:
- have a Quality Management System (QMS) and relevant documentation in place. This is checked and audited by the Philippines FDA during its routine inspections. The QMS must include an established Risk Management Plan (RMP) and Standard Operating Procedures (SOPs) together with their related forms for Good Storage and Distribution, Complaint Handling, Product Recalls, Medical Device Disposal/Destruction
- employ a Qualified Person who is a registered allied health professional or holds a relevant qualification from an allied science courses relevant to the medical device being distributed or imported
- maintain a valid Importer’s Licence (MDDC)
- provide appropriate storage conditions to maintain the safety and quality of imported products
- maintain importation and distribution records (which is required as part of the FDA audit)
- maintain valid product registration certificates (CMDR, CMDN, CPR)
How Andaman Medical can help with importing medical devices to the Philippines:
Andaman Medical holds a valid License To Operate as an Importer of medical devices and in-vitro diagnostics in the Philippines. We remain independent from any final distribution channel partner you choose to appoint ensuring you freedom in your distribution strategy, you may even appoint multiple distributors. Our regulatory affairs specialists and logistics executives will help you to:
- register and import your medical device
- ensure that your product registrations are valid at all times
- ensure your product is correctly labelled
- keep you abreast on the recent changes or new regulations pertaining to medical devices and
- maintain post-market surveillance of your registered product
- liaise with your appointed distributors and the Philippines FDA concerning the mandatory reporting of Adverse Events and Field Safety Corrective Actions
- facilitate customs clearance
We also offer additional support services such as:
- Online regulatory training
- Regulatory intelligence reports giving you insight into the best routes for market access and the latest on the regulatory landscape in your target market