FDA Requirements for the Issuance of an Authorization for the Sale, Manufacture, Importation or Distribution of a Medical Device in the Philippines

What is a medical device?

The regulations issued by the Food and Drug Administration (FDA) of the Philippines defined a ‘medical device’ as any instrument, apparatus, implement, machine, appliance, implant, in-vitro reagent or calibrator, software, material, or other similar or related article intended by the manufacturer to be used alone, or in combination, for human beings for one or more of the specific purpose(s) of: diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of, or compensation for an injury; investigation, replacement, modification, or support of the anatomy or of a physiological process; supporting or sustaining life; preventing infection; control of conception; disinfection of medical devices; and providing information for medical or diagnostic purposes by means of in-vitro examination of specimens derived from the human body.

Administrative Order No. 2018-0002, or the Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements (Guidelines), was issued by the Food and Drug Administration (FDA) to provide guidelines on the documentary requirements for the registration of medical devices.

What are covered by the registration requirements of medical devices?

The Guidelines apply to all medical devices to be sold, imported, exported, manufactured, and used in the Philippines, except in—vitro diagnostic and refurbished medical devices, for which separate Administrative Orders were issued.

What are the different types of authorization?

Authorization here refers to any certification issued to the applicant by Center for Device Regulation, Radiation Health and Research (CDRRHR), showing the product has complied on documentary and technical requirements such as Notification and Registration with certificate.

The following are the different types of authorization issued by the FDA:

1. Certificate of Medical Device Notification (CMDN) — refers to the authorization issued for a medical device that complies with all the requirements for Notification of a medical device. The CMDN is issued for medical devices that will fall under class A.
2. Certificate of Medical Device Registration (CMDR) — refers to the authorization issued for a medical device that complies with all the requirements for Registration of a medical device. The CMDR is issued for medical devices that fall under classes B, C, and D.
3. Certificate of Medical Device Listing (CMDL) —- refers to the authorization issued for a medical device that is intended for research, clinical trial, exhibit, donation, etc. and that is not intended for sale.

What are the classifications of medical devices?

The Philippine classification system for medical devices follow the classification system agreed to under the ASEAN Consultative Committee on Standards and Quality — Medical Device Product Working Group (ACCSQ-MDPWG). The system is rule-based, and the classification is according to the level of risk listed below:

Class   Risk Level

A          Low

B          Low-moderate

C          Moderate-high

D          High

Reclassification of certain devices can be done when the level of risk of the medical device is changed by a certain incident in the manufacture, distribution or use of the device. This shall be done upon proper consultation with the advisory committee created by the Philippine FDA and/or the ASEAN for this purpose.

When applying for registration, the applicant should classify the device based on the list of medical devices per classification issued by the CDRRHR. If the product is not included in the list, the company shall classify the device based on the intended use and on the classification rules of the ASEAN Medical Device Directive. Thereafter, the CDRRHR will verify the classification made by the applicant and shall reclassify the device if another classification is deemed to be more appropriate.

All medical devices under Class A shall apply for Notification of the medical device product, while all medical devices under Classes B to D shall apply for Registration of the medical device product.

The Notification Number or Registration Number shall be issued to the device with an approved CMDN or CMDR.

The distributor/local manufacturer of the device shall inform the CDRRHR in writing within thirty (30) calendar days in case the distributor/local manufacturer has ceased the production or distribution of such device. The list of all approved CMDRs and CMDNs may be viewed and are posted in the FDA’s website.

What are the labeling requirements for Medical Devices?

Product labels of the medical devices with issued CMDR or CMDN shall have the following national labeling requirements, which must be complied with prior to its sale and distribution:

a. Name and address of the importer

b. Name and address of the distributor (if exclusive distributor)

c. CMDN number or CMDR number.

What are the documentary requirements for application for notification and registration?

Legal Requirements for Application for the Notification of Medical Devices under Class A and Registration of Medical Devices under Classes B, C and D

1. Notarized Application Form
2. Payment
3. Copy of Letter of Authorization. For imported medical devices, the copy of the Letter of Authorization shall be accompanied by an original copy of a notarized declaration from the legal manufacturer or product owner attesting that the authorization is true and correct.
4. A government-issued certificate attesting to the status of the manufacturer with regard to the competence and reliability of the personnel and facilities, a Quality Systems Certificate of approval, or a compliance certificate for ISO 13485. For imported medical devices, the copy of the certificate shall be accompanied by an original copy of a notarized declaration from the legal manufacturer or product owner attesting that the certificate is true and correct.
5. For imported medical devices, the Certificate of Product Notification, Certificate of Product Registration, or any equivalent document attesting to the safety and effectiveness of the device issued by the regulatory agency or accredited notified body in the country of origin. The copy of the certificate shall be accompanied by an original copy of a notarized declaration from the legal manufacturer or product owner attesting that the certificate is true and correct.
6. Colored picture of the device from all sides. However, the CDRRHR can require a representative sample or commercial presentation for verification purposes.

What process with the application for notification or registration undergo with the FDA?

The application shall be evaluated by the Food and Drug Administration’s CDRRHR within one hundred eighty (180) days upon filing of the applications. All applications that do not comply with the technical requirements shall be notified through a letter indicating the deficiencies. The FDA will allow the applicant a one-time chance to correct the deficiencies within ninety (90) days from receipt of the letter.

If the applicant still fails to comply with the requirements, he/she will be given a chance to re-apply, with a corresponding fee, and to submit the complete compliance documents within sixty (60) days. Any further failure to comply with the required documentation within the given period shall be a ground for final disapproval of the application.

How long shall the CMDN and the CMDR be valid?

The CMDN and the CMDR shall be valid for five (5) years and shall be renewed every five (5) years after the initial approval.

What medical devices are exempted from notification and registration?

Medical devices strictly for research, clinical trials, exhibit, and/or donated brand new medical devices are exempted from Notification and Registration. However, the researcher, institution, and/ or user of such devices must apply for a Certificate of Medical Device Listing with the FDA.

What are the grounds for disapproval of the application?

The following are the grounds for disapproval, cancellation, revocation and/or non-renewal of a CMDN and a CMDR:

1. The manufacture, sale, offer for sale, or transfer of a medical device that does not meet all the requirements of safety and effectiveness;
2. Misrepresentation or concealment of significant data or information about the product sought to be registered;
3. Alteration, mutilation, destruction, obliteration, or removal of any part of a label;
4. A medical device that has a biological, chemical, or physical property that may cause an unacceptable health risk;
5. Submission of falsified document(s);
6. Alteration or falsification of an issued CMDN or CMDR.

When will the application be disapproved and what happens to the disapproved applications for notification and registration?

As mentioned above, applications with deficiencies shall be given a one-time compliance period. If there are still deficiencies in the application, the FDA will consider the application disapproved. However, the applicant may opt to submit a reapplication within sixty (60) calendar days from the time the applicant is notified of the disapproval. If, despite all these chances, the FDA’s directives are still not met, the application will be automatically disapproved.

Disapproved applications shall be returned to the applicant. In case the applicant does not claim the disapproved applications within 90 calendar days, the application documents shall be destroyed and discarded.

Unregistered or unnotified medical devices cannot be sold, marketed, distributed, or imported. If sold without the required notification or registration from the FDA, the FDA may seize the unregistered medical devices and subject the persons responsible for putting the unregistered medical device in the Philippine markets to administrative and/or criminal penalties and fines.

About Nicolas and De Vega Law Offices

If you need assistance in registration with the Food and Drug Administration, applications for Licenses to Operate, drug, cosmetic, medical device or food registration, assistance in medical device notifications or registrations filed under the ASEAN Harmonization Law, or have issues in corporate law, commercial law, corporate or commercial litigation, or civil or other criminal law-related issues,  we can help you. Nicolas and de Vega Law Offices is a full-service law firm in the Philippines.  You may visit us at the 16th Flr., Suite 1607 AIC Burgundy Empire Tower, ADB Ave., Ortigas Center, 1605 Pasig City, Metro Manila, Philippines.  You may also call us at +632 84706126, +632 84706130, +632 84016392 or e-mail us at [email protected]. Visit our website https://ndvlaw.com.