Medical device distribution in 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).
Who can distribute medical devices in the Philippines?
- Only Filipino companies that hold a valid License To Operate (LTO) as a Medical Device Manufacturer or Distributor (Importer/Exporter/Wholesaler) (MDDC) may distribute medical devices in the Philippines. The LTO can be applied for via the e-services system and once approved it will be issued by the FDA.
- What is important to remember is that multiple distributors may be appointed in the Philippines as long as the agreement between the manufacturer and the distributor is non-exclusive. However, this will increase your initial product registration costs as each distributor must register the medical device separately because only product license holders may import your medical device.
- Even though a company must have a valid LTO to distribute, this same company does not necessarily have to be the Product License Holder. So, to take full advantage of having multiple distributors at a lower cost, you can appoint a Local Authorized Representative (LAR) who will register, import and act as a master distributor for your medical devices, which means that you only need to register your medical devices once. As a master distributor, the LAR works alongside your final distribution channel partners to get your product to the end-user.
- If issues arise with your existing distributor who is also your product license holder, an option exists to change ownership or transfer the Product Approval License to the new company once the contract/deed of assignment is terminated, an agreement between the manufacturer and the new importer/distributor is in place and the original copy of Product Approval License is given to the new distributor license holder. For manufacturers, this can prove difficult and costly to obtain, should the existing product license holder not wish to relinquish their right to distribute the product in the Philippines. Hence the advantage of appointing an independent third party or Local Authorized Representative (LAR) as the Product License Holder.
- Choosing to work with an LAR rather than directly with an distributor gives you real flexibility in your distribution strategy. This means you can adapt quickly to changes in the market by adding new distributors, increase transfer pricing as well as ensuring rigorous quality and compliance controls continue post-market.
- It is vital to choose the correct partner as they are responsible for registering, importing and distributing your medical device to your customers or channel partners.
What are the requirements for distributing medical devices in the Philippines?
- In order to distribute a medical device in the Philippines, a company must have a valid License to Operate (LTO) as a Medical Device Distributor (MDDC)
- A company must have the product’s valid Certificate of Medical Device Registration (CMDR) / Certificate of Medical Device Notification (CMDN) / Certificate of Product Registration (CPR)
- The appointment of a distributor 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 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.
Advertising rules
Advertising, communication and promotion of medical device is part and parcel of distribution. In Philippines, promotion and marketing of medical devices should comply with AO 2015-0053: Implementing Guidelines on the Promotion and Marketing of Prescription Pharmaceutical Products and Medical Devices. For sales promotions involving prizes, a permit must be obtained from the FDA. The fees due depend on the value of the prizes available.
Distributor’s duties and obligations
It is mandatory for distributors of medical devices and IVDs in 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
- maintains a valid Distributor’s License (MDDC)
- be compliant to the standards of GDPMD even though this specific certification is not mandatory in the Philippines, the principles are expected to be complied with for any company issued with an LTO and will form part of the FDA audit
- audit 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)
- make sure that products are properly labelled and advertised according to the approved claims of FDA.
How Andaman Medical can help with distributing medical devices in the Philippines:
Andaman Medical holds a valid License To Operate as an Importer of medical devices, 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
- facilitate customs clearance
- 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.
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.