In June 2013, the National Health Insurance Act was signed into law, making national healthcare coverage available to all Filipinos. Currently, more than 80% of Filipinos are covered under the scheme. However, the coverage provided is very limited. In late September 2014, the Philippines releaseddraftdevice registration document requirements based on the ASEAN Medical Device Directive (AMDD).
With the help of Pacific Bridge Medical’s registration consultants, your medical device can be approved quickly in the Philippines. We will help you achieve compliance with Philippine regulations so you can import and register your medical devices in the Philippines as soon as possible.
To find out more information on the proposed outline for Philippines medical device registration, click on the questions below.
Which regulatory bodies in the Philippine government are responsible for medical device registration in the Philippines?
The Philippines’Food and Drug Administration (FDA),formerly the Bureau of Food and Drugs (BFAD), was created under the Department of Health to license, monitor, and regulate the flow of food, drugs, cosmetics, medical devices, and household hazardous waste in the Philippines.
In the Philippines, are medical devices required to be registered before they can be sold?
Yes, medical devices require registration before being sold in the Philippines.
What are the different regulatory classifications for medical devices?
The draft device registration requirements released in September 2014 better align the Philippines with ASEAN’sCommon Submission Dossier Template (CSDT). In the near future, the classification rules shall be based on the ASEAN Medical Device Directive (AMDD).
- CLASS A – Low risk (e.g. bandages)
- CLASS B – Moderate risk
- CLASS C – Moderate/high risk
- CLASS D – High risk (implantable defibrillators)
What does the registration pathway look like for each regulatory classification?
According to the draft regulations from September 2014,
- CLASS A – Medical devices under this classification must apply for a Certificate of Medical Device Notification (CMDN).
- Submit the application for notification.
- The Philippines FDA reviews the application.
- If approved, a Notification Number will be issued to the device.
- If all the documents are accurate, a notification number will be issued to the device and the applicant is approved for the CMDN.
- Class B to D –Medical devices under this classification must apply for a Certificate of Medical Device Registration (CMDR).
- Prepare dossier.
- Submit the application dossier (CSDT format) for registration.
- The Philippines FDA reviews the application dossier and supporting documents.
- If further information is requested, the applicant must submit answers addressing the supplementary questions.
- If all the documents are accurate, the applicant is approved for a CMDR.
Timeline – 3-6 months for approval.
What are the document requirements for registration for each regulatory classification?
CLASS A (CMDN Application)
- Documents required for theCMDN application:
- Notarized e-copy affidavit
- Notarized application form
- Photocopy of the valid License to Operate in the Philippines issued by the FDA
- Proof of payment or order of payment
- For distributors, the Certificate of Agreement between the Manufacturer and Distributor regarding the device; for imported medical devices, the Philippine consulate must appropriately authenticate the Certificate
- Government certificate attesting to the status of the Manufacturer ‘s competency and reliability of the personnel and facilities or Quality Systems Certificate of approval or compliance certificate with ISO 9000 series or ISO 13485
- For imported medical devices, Certificate of Product Notification or Certificate of Product Registration or any equivalent document attesting to the safety and effectiveness of the device issued by the regulatory agency/accredited notified body in the country of origin and duly authenticated by the territorial Philippine Consulate. A certificate of free sale shall not be accepted
- Representative sample or commercial presentation of the product, when needed, and a color picture of the device
- Technical requirements in accordance with the CSDTof the AMDD:
- Device description consisting of the following:
- Intended use
- Instruction for use
- List of all raw materials
- Technical specification of the finished product
- List of reference codes, sizes, colors, models and variance, whichever is applicable.
- Sterilization method and sterility test done on the device
- Certificate of conformity to the aspect of manufacturer relating to metrology for devices with measuring functions
- Declaration of conformity (self-declaration by the manufacturer) with product standards, if applicable
- Sample of labels on the device and its packaging and other labeling materials to be used for the device that includes user’s or instruction manuals
- Stability studies of the product to justify claimed shelf life, if applicable
- Device description consisting of the following:
CLASS B (CMDR Application)
- National Legal Requirements:
- Notarized e-copy affidavit
- Notarized application form
- Photocopy of the valid License to Operate in the Philippines issued by FDA
- Proof of payment or order of payment
- For distributors, the Certificate of Agreement between the Manufacturer and Distributor regarding the device; for imported medical devices, the Philippine consulate must appropriately authenticate the Certificate
- Quality Systems Certificate of Approval on Manufacturing, or compliance certificate with ISO 9000 series or ISO 13485;for imported medical device, the Certificate shall be duly authenticated by the territorial Philippine Consulate
- For imported medical devices, a Certificate of Product Notification or Certificate of Product Registration or any equivalent document attesting to the safety and effectiveness of the device issued by the regulatory agency/accredited notified body in the country of origin and duly authenticated by the territorial Philippine Consulate
- Representative sample or commercial presentation of the product, when needed, and colored picture of the device
- Technical requirements in accordance with the CSDT of the AMDD:
- Executive summary
- Relevant essential principles and method/s used to demonstrate conformity, if applicable
- Device description (including intended use, warnings, precautions, potential adverse effects, etc)
- Summary of design verification and validation documents (e.g. declaration certificates, medical device labeling samples, risk analysis, etc.)
- Physical Manufacturer information:
- Manufacturing process, including quality assurance measures
- A brief summary of the sterilization method
CLASS C (CMDR Application)
- All of the requirements of class B, except for pre-clinical studies
- Risk assessment consisting of risk analysis, evaluation and reduction measures
- Clinical evidence for the following:
- Implantable devices
- Newly introduced devices
- Devices incorporating new materials coming into contact with the patient
- Existing materials applied in a body part not previously exposed to that material, and for which no prior chemical experience exists
- An existing device that is modified and the modification might affect safety and effectiveness
- Software validation studies, if applicable
- Biological evaluation, if applicable
CLASS D (CMDR Application)
- All requirements for class C, except clinical evidence items
- List of countries where the device has been sold
- A summary of all studies on which the manufacturer relies to ensure that the device meets the safety and effectiveness
- A bibliography of all published reports dealing with the use, safety, and effectiveness of the device
- Objective evidence (study) on biological safety of the device, if the device contains animal or human tissue or their derivatives
Is local testing (type testing/sample testing) required for registration?
Local testing is generally not a requirement for medical device registration in the Philippines.
When are clinical studies required for registration?
Clinical data is generally required for the following devices:
- Implantable devices
- Newly introduced devices
- Devices incorporating new materials coming into contact with the patient.
- Existing materials applied in a body part not previously exposed to that material, and for which no prior chemical experience exists.
- An existing device that is modified and the modification might affect safety and effectiveness.
Foreign clinical data is usuallyaccepted.
Is approval in the Country of Origin required for registration?
Yes, approval in the country of origin is a requirement for registration.
Contact ustoday to speak with one of our experts in Philippine regulatory compliance.
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FAQs
How to register medical device with FDA Philippines? ›
In order to register a medical device in the Philippines, a company must first obtain a License to Operate (LTO) which is essentially an establishment registration as a Medical Device Manufacturer or Distributor (MDDC). Distributor status includes importers, exporters and wholesalers.
How can I get FDA approval in the Philippines? ›- Petition form. ...
- Joint Affidavit of Undertaking. ...
- Certificate of Attendance to an FDA-sponsored seminar on licensing of establishments. ...
- Proof of business registration. ...
- Proof of occupancy or business address. ...
- Floor plan and vicinity map.
FDA Registration Services in the Philippines
Foreign investors and enterprises that intend to do business in the Food, Pharmaceutical or Cosmeceutical industries in the Philippines are required to register their products with the Food and Drug Administration (FDA).
Fees to be Paid : AO No. 50 s. 2001 Branded: PHP 10,000.00 + 1% LRF Unbranded: PHP 7,500.00 + 1% LRF Additional (if with variation/s) Payment shall be based on FDA Circular No.
What is FDA equivalent in Philippines? ›The Food and Drug Administration (FDA) of the Philippines, formerly the Bureau of Food and Drugs (BFAD /ˈbiːfæd/; 1982–2009), is a health regulatory agency under the Department of Health created on 1963 by Republic Act No.
How much does it cost to get FDA approval for a medical device? ›The overall cost to get FDA approval for a 510(K) notification ranges between $30,000 and $44,000 USD. This includes the preparation of the submission and all associated FDA costs.
How do I check my FDA registration Philippines? ›- Click on the below link. https://www.accessdata.fda.gov/scripts/cder/drls/getdrls.cfm.
- Enter the company name in query box. FDA Drug Establishment Search.
- After you perform search action , name of the establishment, address and validity of the registration will appear.
No drug establishment shall manufacture, import, export, sell, offer for sale, distribute, transfer, promote, advertise and/or sponsor any activity that involves drug product without first securing an LTO or an appropriate authorization from FDA pursuant to this Administrative Order.
Does it cost money to get FDA approval? ›FDA Annual Establishment Registration Fee – $6,493 (2023)
The FDA charges a flat registration fee for for all businesses interested in manufacturing or marketing their products and devices in the United States. If your company is already registered with the FDA, then there is no additional charge.
Under federal regulations at Title 21, Code of Federal Regulations (CFR), section 1.227 (21 CFR 1.227), a private residence is not a “facility” and thus, is not required to be registered with FDA.
How to register medicine in Philippines? ›
A hard copy of the integrated application form is required. Once an applicant submits the application dossier, the FDA through the Center for Drug Regulation and Research (CDRR), evaluates the documents and determines if the product meets the requirements of safety, efficacy, and quality.
Who must register with FDA for medical devices? ›Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. This process is known as establishment registration.
Is FDA Approval hard to get? ›On average, it takes ten years and hundreds of millions of dollars to get a new medication approved by the FDA. Only about ten percent of potential drugs make it through the rigorous process to become FDA approved. Despite these challenges, researchers remain hard at work to develop new safe and effective medications.
How long is FDA LTO valid? ›Unless revoked, the LTO shall have the following validity period: a. An initial license issued shall be valid for three (3) years b. A renewed license shall be valid for five (5) years.
Do you need a patent to get FDA approval? ›Patent information is required to be submitted with original new drug applications (NDAs) and supplements on FDA Form 3542a prior to approval.
Does the Philippines have an FDA? ›The Philippine Food and Drug Administration (FDA) is holding a consultation on its draft implementing guidelines on the collaborative procedure for the accelerated registration of World Health Organization (WHO)-prequalified pharmaceutical products and vaccines.
How do I know if my FDA certificate is real Philippines? ›Tap the notification to navigate to the FDA Unified Registration and Listing System Export Certification Validator (FECV) Portal. Enter the unique eCPP number to verify the eCPP and view a copy of the certificate associated with the QR code.
What is certificate of product registration FDA Philippines? ›The FDA Certificate of Product Registration (CPR) is a requirement if you plan to sell any of the following items in the Philippines: Food products (beverages, water, canned goods, etc.) Food Supplements. Medicines, Over-The-Counter Drugs, and other Pharmaceutical products.
Can medical devices be sold without FDA approval? ›In short, no. In order to market or sell a medical device, it must be registered, cleared, or approved by the FDA. In 1976, Congress amended the Federal Food, Drug, and Cosmetic Act to allow the FDA to regulate medical devices before they're legally sold in the US. This was done to ensure safety and effectiveness.
How long does FDA device approval take? ›The FDA approval process can take between one week and eight months, depending on whether you self-register, submit a 510(k) application or submit a Premarket Approval (PMA) application. Bringing a medical device to market is not a fast process.
How long does FDA approval take? ›
Priority Review means that FDA aims to take action on an application within six months, compared to 10 months under standard review.
How do I know if my medical device is FDA approved? ›- Go to the Devices@FDA Database.
- In the Enter a search term in the space below field, type the name of the device or the company name. ...
- Click Search.
Access the online portal through eservices.fda.gov.ph and click “Applications” found on the upper right corner of the eServices landing page. 2. Click the “License to Operate” for Food and the type of Business Establishment (Distributor).
How do I get FDA approval certificate? ›- FDA officials visit the food and drug plants in foreign countries.
- The official of FDA then issues the Form 483 to the manufactures after the completion of the inspection. ...
- The FDA also issues an EIR (Establishment Inspection Report).
What is a License to Operate (LTO)? LTO is an authorization issued by the FDA to an establishment to grant permission to undertake a trade or carry out a business activity, such as manufacturing, importation, exportation, sale, offering for sale, distribution, or transfer of food products.
How do I report unregistered product in FDA Philippines? ›To report continuous sale or distribution of unregistered health products, kindly e-mail us via ereport@fda.gov.ph. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596.
What products do not need FDA approval? ›The FDA does not approve cosmetics.
Examples of cosmetics are perfumes, makeup, moisturizers, shampoos, hair dyes, face and body cleansers, and shaving preparations. Cosmetic products and ingredients, and their labeling, do not require FDA approval.
Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition.
How much is FDA 510k registration? ›The standard user fee for FDA review of a 510k is $19,870 for FY 2023. The third option is to apply for small business status. For companies that have annual revenues of less than $100 million USD, the FDA will grant you small business status.
How much does it cost to register with FDA? ›...
User Fees for FY2023.
Application Type | Standard Fee | Small Business Fee† |
---|---|---|
510(k) | $19,870 | $4,967 |
513(g) | $5,961 | $2,980 |
PMA, PDP, PMR, BLA | $441,547 | $110,387 |
What is the difference between EUA and FDA approval? ›
EUA means the vaccine can be approved by the FDA quickly compared to a traditional FDA-approval process, but that doesn't mean it cuts corners when it comes to evaluating vaccine data, risks and benefits.
Do Class 1 medical devices require FDA approval? ›Class 1 medical devices are devices with low or moderate risk to patient health and safety. 47% of approved medical devices are Class 1, and 95% of these devices are exempt from the PMA pathway to regulatory approval. Class 1 device manufacturers are required to register their device with the FDA, however.
Do Class 1 devices require FDA approval? ›The majority of Class I devices are exempt from FDA requirements for Premarket Notification (510k) and Premarket Approval (PMA). Class I devices are not exempt from FDA general controls, a series of commands which applies to Class I, II, and III medical devices.
What is the importance of FDA in the Philippines? ›The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.
What are the requirements to practice medicine in Philippines? ›(1) is a natural-born citizen of the Philippines, (2) is a duly registered physician in the Philippines, (3) has been in the practice of medicine for at least ten years, (4) is of good moral character and of recognized standing in the medical profession as certified by the Philippine Medical Association, (5) is not a ...
Do all medical devices need FDA approval? ›In the U.S., FDA regulates the sale of medical device products. Before a medical device can be legally sold in the U.S., the person or company that wants to sell the device must seek approval from the FDA.
How much are FDA registration fees 2022? ›For FDA user fees 2022, the registration fee for each establishment is $5,672 (in United States dollars). There are no waivers or reductions for small establishments, businesses, or groups. The annual establishment registration fee must be paid between October 1, 2021, and December 31, 2021.
What are Class I II and III medical devices FDA? ›The regulatory controls for each device class include: Class I (low to moderate risk): general controls. Class II (moderate to high risk): general controls and Special Controls. Class III (high risk): general controls and Premarket Approval (PMA)
What are the 4 phases of FDA approval? ›- Step 1: Discovery and Development.
- Step 2: Preclinical Research.
- Step 3: Clinical Research.
- Step 4: FDA Drug Review.
- Step 5: FDA Post-Market Drug Safety Monitoring.
There are three primary phases of the approval process: pre-clinical trials, clinical trials, and new drug application review.
What is the success rate of FDA approval? ›
Overall success rates from Phase I to FDA approval is nearly 9%. This number is comprised of lead and secondary indications. When separated, lead indications have close to a one in seven rate of approval and secondary indications have a rate of one in 30.
Does LTO medical certificate expire? ›In a Facebook post, the LTO announced that it is extending the validity of student permits, medical certificates, and conductor's licenses expiring in the first quarter of 2022. All of the said documents will be valid for another two months past their date of expiration.
What are the grounds for disapproval of LTO? ›The evaluation of all applications for LTO shall be based on the veracity of the submitted documents and compliance with appropriate standards. In case the applicant falsified, misrepresented material facts or documents, or withheld any material data or information, the application shall be disapproved.
Does certificate of registration expire LTO? ›The registration is only valid for three years. After that, you have to renew your vehicle according to your schedule or get a PHP 200 fine per week that you miss. The last digit of your license plate number indicates the month when you should renew your vehicle after years.
What is 3 year FDA exclusivity? ›A 3-year period of exclusivity is granted for a drug product that contains an active moiety that has been previously approved, when the application contains reports of new clinical investigations (other than bioavailability studies) conducted or sponsored by the sponsor that were essential to approval of the ...
How much does it cost to get a patent approved? ›While the costs of an application vary depending on the representation, the total costs run from $5000 to $8000. These costs incorporate attorney's fees associated with drafting and filing the patent, as well as USPTO filing fees. These fees typically cost between $360 and $720, with examination fees totaling $170.
Can I sell something that is not FDA approved? ›As long as companies meet conditions and make specific claims that match those listed on the FDA's product list, companies are allowed to bring their product to market without FDA approval through this pathway.
How do I register a medical device with the FDA? ›...
If your premarket submission is cleared or approved, you will need to do the following to list your device:
- Enter the premarket submission number.
- Enter the proprietary name(s)
- Identify the activities that you perform on or to the device.
- Know Your Device's Classification. Medical devices fall into three classes: ...
- Develop a Prototype. The next step is to develop a prototype. ...
- Submit Your Applications (If Applicable) ...
- Wait for FDA Review and Approval. ...
- Maintain FDA Compliance.
All FDA regulated Medical Device Establishments applying for LTO shall be required to accomplish online application through the eServices Portal (eservices.fda.gov.ph/). Creation of account and password is no longer a requirement to obtain access to the online portal.
What is required for FDA approval of a medical device? ›
Devices undergo laboratory and animal testing to answer basic questions about safety. Devices are tested on people to make sure they are safe and effective. FDA review teams thoroughly examine all of the submitted data related to the drug or device and make a decision to approve or not to approve it.
How much does it cost to register with the FDA? ›...
User Fees for FY2023.
Application Type | Standard Fee | Small Business Fee† |
---|---|---|
Annual Fee for Periodic Reporting on a Class III device (PMAs,PDPs, and PMRs) | $15,454 | $3,864 |
The FDA approval process can take between one week and eight months, depending on whether you self-register, submit a 510(k) application or submit a Premarket Approval (PMA) application. Bringing a medical device to market is not a fast process.
What is the difference between 510K and PMA? ›What's the difference between a 510K vs PMA? 510(k) clearance is authorisation from the FDA to market a medium-risk medical device, while PMA (premarket approval) is required for more high-risk and novel products.
What is the difference between FDA registered and FDA approved? ›To be clear, all medical devices sold in the USA must be registered with the FDA, or "FDA Registered." So, even a Class I medical device must be FDA Registered. If a device is only FDA Registered, the manufacturer cannot claim that it's Approved or Cleared.
How hard is it to get FDA approval? ›Only about ten percent of potential drugs make it through the rigorous process to become FDA approved. Despite these challenges, researchers remain hard at work to develop new safe and effective medications.
What is 510k approval for medical devices? ›Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k).
What are the 5 steps for FDA approval? ›FDA Drug-Approval Process. A pharmaceutical company seeking FDA approval to sell a new prescription drug must complete a five-step process: discovery/concept, preclinical research, clinical research, FDA review and FDA post-market safety monitoring.
Who is required to have an FDA registration number? ›Food. Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for consumption in the U.S. are required to register the facility with the FDA.