菲律賓FDA註冊

Philippine Medical Device Registration

Medical device industry is a great prospect sector for the Philippines as development in the market continues to present opportunities for foreign manufacturers of high-value, low-volume products of the latest technology and highest quality.Qualtech is your ideal partner to for your foray into the Philippines medical device market for an easy and smooth registration process.

Qualtech in Philippines

Possess LTO Certificate

License to Operate is an Establishment License of medical device enterprise issued by Philippines government.

Specific in High Risk Implant

Qualtech Philippines team has assisted over 100 implantable products obtain PFDA licenses, including cosmetic filler, surgery suture, bone graft…and so on.

QT Services

Medical Device Registration

Our in – house experts are able to provide you with excellent professional service in preparing customized ASEAN Common Submission Dossier Template (CSDT) and liaise with PFDA officers to get your devices registered in the Philippines.

Authorized Representation

As an in – country authorized representative (AR), Qualtech can hold a medical device registration license on behalf of foreign manufacturers looking to market medical devices in the Philippines. This is in compliance with the law for a local establishment to be a license holder.

Implementation of New Regulation

PFDA implemented FDA Circular No. 2020-001, Initial implementation of DOH Administrative Order No. 2018-0002 (Guidelines Governing the Issuance of an Authorization for a Medical Device Based on the ASEAN Harmonized Technical Requirements), starting last March 17, 2020. This is in compliance with Section IX of the said A.O., Phase 1: Notiﬁcation of Class B, C and D that are non-registrable medical devices based on FDA 2014-005. This also includes a list of medical devices with classification-based ASEAN MDD with modifications to the medical device list in FDA 2014-005 and FDA 2014-005A.

Major change in new regulation:

Replace of CPR, using CMDN for Class A device, and CMDR for Class B, C, D device. The new brand of device with all class shall have CMDL.
Previously issued COEs for medical devices for class A in the updated list shall only be valid until November 3, 2021.
COE will NO LONGER be issued for non-registrable products but in case of point of entry and/or as part of bidding requirements, the License to Operate (LTO) of the establishment should be provided.
Medical devices under class B, C and D, and IVDs which are NOT included in FDA 2014-005 and 005A shall be considered non-registrable.

Classification

Class A

Low risk device

Type of Certificate: CMDN (Certificate of Medical Device Notification)

Online submission

Class B

Low-Moderate Risk

Type of Certificate: CMDR (Certificate of Medical Device Registration)

Manual submission

Class C

High-Moderate Risk

Type of Certificate: CMDR (Certificate of Medical Device Registration)

Manual submission

Class D

High Risk

Type of Certificate: CMDR (Certificate of Medical Device Registration)

Manual submission

TECHNICAL REQUIREMENTS
	CLASS A	CLASS B	CLASS C	CLASS D
Executive Summary		Yes	Yes	Yes
Essential Principles and Methods		Yes	Yes	Yes
Device Description	Yes	Yes	Yes	Yes
Summary of Design V&V		Yes	Yes	Yes
Clear and Colored Pictures of Label	Yes	Yes	Yes	Yes
Risk Assessment		Yes	Yes	Yes
Physical Manufacturer Information		Yes	Yes	Yes
Clinical Evidence			Yes	Yes
Bibliography of all published report				Yes
Declaration of Shelf - Life	Yes	Yes	Yes	Yes

Note: Kindly see the Annexes B – E of DOH AO 2018 – 0002 for more details.

Workflow

FDA Target Reviewing Turnaround Time

After successful internal evaluation of the submission dossier, our in – house experts will then submit it to the FDA and will be subjected to thorough evaluation. Below is a list of the turnaround times for different types of transactions involving product registration/notification.

Initial Registration

The evaluation process for initial registration takes about 180 to 365 calendar days (6 months to 1 year) from the date of the filing of application.

Regular/Automatic Renewal

Renewal evaluation takes about 90 calendar days (3 months)

First Compliance

Registrants will be given 90 calendar days (3 months) to correct their deficiencies for the initial registration.

Second Compliance

If registrants fail to correct deficiencies on the first compliance, a period of 60 calendar days (2 months) will be given for the second compliance. This compliance will require an additional PFDA fee. Failure to do so will result in disapproval of application.

Validity

Types of Certificates: CMDR, CMDN
Initial approval validity: 5 years
Renewal interval: 5 years

Workflow

Medical Device Grouping Principle

PFDA application shall be made separately for each specific medical device. However, filing one application that will yield multiple certificates is applicable in the following conditions where the medical device.

Has accessories that are intended to be sold separately
Is owned by the same legal manufacturer but manufactured in different plants and will be both distributed at the same time in the Philippines.
With same intended use and manufacturing process but has different raw materials.
With same intended use and manufacturing process but has different design.
With same raw materials but has different types or shapes, which results in different specific intended use.

For more information, please refer to the FDA Philippines’ official website at http://www.fda.gov.ph or you may contact us for a free consultation.

Official Website

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