Chapter 1 Philippine PFDA Administration Information Abstract

1. Administration and Abstract

The Philippine Food and Drug Administration (PFDA) is responsible for approval and supervising the market access, distribution and subsequent compliance regulation of medical devices.

2. Administrative Regulation

[REPUBLIC ACT NO. 9711]

[The Rules and Regulations 
Implementing Republic Act No. c)71I-'the Food and Drug [Administration Act of 2009] 

3. Risk Level Classification of Medical Device and IVD Products

①The Philippines product classification is harmonized according to Appendix 3 of the ASEAN Medical Device Directive AMDD, which classifies medical devices such as instruments, machines, in vitro reagents, software and similar or related articles for therapeutic or medical purposes into four levels A, B, C and D, from low risk to high risk.

② Certificate of Medical Device Notification (CMDN) is applicable to Class A medical devices.
③ Certificate of Medical Device Registration (CMDR) is applicable to Class B, C and D medical devices.

④ Certificate of Medical Device Listing (CMDL) - refers to the authorization issued for medical devices that are used for research, clinical trials, exhibitions, donations, etc. and not for sale.

In the Philippines, devices containing drugs are not considered as medical devices.

IVD (in vitro diagnosis) is classified separately from other medical devices and is also classified into class A, Class B, Class C and Class D according to the risk from low to high. In vitro diagnostic (IVD) medical devices are classified as registrable and unregistrable. Currently, only eight IVD medical devices are considered registrable

①HIV (antibodies and/or antigens), HBV (HBsAg and other markers), HCV (antibodies and/or antigens) and syphilis kits

②Single or combination drug screening kits/reagents for alternative drugs

③ Anti-A, anti-B, anti-D, anti-AB blood group serum

④ Anti-human globulin reagent

⑤ Enzyme, LISS and albumin and other synergists

⑥ Column agglutination test for cross matching and blood type

⑦ Pregnancy test kit/reagent

⑧ Leptospirosis test kit/reagent

⑨ Blood collection tube

4. Entry Requirements

①Both MD and IVD require a QMS audit report from ISO 13485 or the US FDA or PMDA in Japan to demonstrate the quality system of a legitimate or actual manufacturing facility.

②Letter of Authorization (A copy of the authorization shall be accompanied by the original notarized statement of the legitimate manufacturer or product owner certifying the authenticity of the authorization).

③Government-issued certificates attesting to the manufacturer's standing with respect to the competence and reliability of personnel and facilities, quality system approval certificates, or ISO 13485 compliance certificates (copies of the certificates should be accompanied by a copy of the original notarized statement from the rightful manufacturer or product owner attesting to the authenticity and correctness of the certificate).

④A product registration certificate or any equivalent document certifying the safety and effectiveness of the device issued by the regulatory authority or recognized notified body of the country of origin (copies of the certificate should be accompanied by the original notarized declaration of the legitimate manufacturer or product owner certifying the authenticity of the certificate).

⑤In addition to the above documents, it is also necessary to provide equipment description, certificate of conformity, declaration of conformity, shelf life statement and clear, complete, color label pictures.

⑥ For IVD products, technical documents must be submitted according to the corresponding requirements for different risk levels.

5. Registration Language

English.

Chapter 2 Registration Flow, Cycle & Official Fee

1. Registration Flow 

2. Registration Approach

3. Cycle & Official Fee

Application fee:

The application fee for Class A, Class B, Class C and Class D medical devices is PHP7,500.

Registration cycle:

Class A: within 4 weeks to 12 weeks

Class BCD: 180 days

Chapter 3 FAQ

Q: What is a License to Operating (LTO)?

A: An LTO is an authorization issued by the FDA to a business to grant a license to conduct trade or conduct commercial activities, such as the manufacture, import, export, sale, offer for sale, distribution, or transfer of a medical device.

Q: How long is the medical device registration certificate valid? How long in advance does it require to renew the certificate?

A: Five years, and you can submit a renewal application 90 days before the expiration date.

Q: What materials are required for a medical device listing application?

A: Notarized application form, a notarized letter to the relevant agency stating the intended use and responsibility, a document certifying the safety and effectiveness of the product issued by the regulatory agency of the country of origin, and a copy of the SEC or DTI registration, if applicable, are required.

Q: Are multiple holders of medical devices allowed in the Philippines?

A: A company that has obtained a CMDN/CMDR/CPR or product approval license is also called a product license holder. If the agreement between the manufacturer/supplier and the distributor (importer/exporter/wholesaler) is non-exclusive, multiple registrations of medical devices using different distributor license holders are allowed in the Philippines.

Q: Is the certificate transferable?

A: Yes.

Q: How long is the Philippine product registration certificate valid?

A: CMDN and CMDR certificates are valid for five years and can be renewed thereafter. Applications for registration or notice of renewal of the CMDR and CMDN should be submitted within 90 days before the expiration of the CMDR and CMDN. Applications for renewal of the CMDR submitted after 120 days after the expiration of the CMDR will not be accepted and shall be considered as initial applications.

Q: How long is the approval cycle for certificate renewal?

A: Renewal applications will be assessed within 30 days of submission of the application. All applications that do not meet the technical requirements will be notified by letter and given an opportunity to correct defects within thirty days.