July 13, 2018

Following the Executive Presentation on the New Fee Structure and Modernization Initiatives held last June 28-29, a draft of the New Schedule of fees has been posted which aims to notify all stakeholders concerning the significant increase in charges associated with medical registration, licensing, and other authorization applications. PFDA currently seeks public opinion with regards to this matter.

The draft of new fees are hereby presented as follows:

A.  Medical Device Products

Risk Class

Application Fee (Per Device)

Evaluation Fee (Per Device)

Annual Fee (Per Device)

Class A

5,000

10,000

2,000

Class B

10,000

15,000

5,000

Class C

15,000

25,000

9,000

Class D

(includes devices incorporating medicinal/therapeutic

products)

30,000

60,000

12,000

 *fees are in Philippine Peso

*Annual fees shall be collected each year upon the issuance of marketing authorization. Noncompliance shall lead to the revocation of the marketing authorization.

 

B.  Variations

Risk Class

Major Variation Fee

Minor Variation Fee

Class A

2,500

1,000

Class B

10,000

5,000

Class C

10,000

5,000

Class D

(includes devices incorporating medicinal/therapeutic

products)

20,000

5,000

 

The application fees granting an authorization being referred herein are as follows:

1) Receiving of application documents through manual and online submission systems;

2) Assessment, evaluation, and review of application documents;

3) Inspection of establishments related to the licensing applications;

4) Printing of one (1) original copy and issuance of additional nineteen (19) electronic authenticated copies of the LTO and CPR; and

5) Records management and archiving.

 

The application fees shall not cover the following expenses:

1) UP Law Center’s Legal Research Fee (LRF) which is equivalent to P10.00 or 1% of the application fee, whichever is higher, as imposed by RA 3870, as amended by PD 200 and further amended by PD 1856, of which FDA is only the collecting agent as per Letter of Instruction No. 1182 dated 16 December 1981;

2) Other fees incurred from the use of payment collection facilities, such as service fees charged by banks authorized by the FDA to collect its fees;

3) Courier services to deliver the authorization;

4) Such other services not listed in the previous section.

 

Other key points of the draft regulation are hereby outlined as follows:

  • Payment of fees shall still follow the existing policies and procedures. Fees, either in the form of cash or manager's check shall be collected only through FDA Cashier and all authorized FDA Satellite Cashiers.
  • Annual fees shall be collected each year upon the issuance of marketing authorization. Noncompliance shall lead to the revocation of the marketing authorization.

Renewal applications for LTO, CPR or market authorizations received after the expiration date shall be subject to a surcharge od penalty, which is equivalent to twice the renewal fees, with an additional payment of 10% of the renewal fee per month or a fraction thereof, continuing non-submission up to a maximum of 120 days. Any applications filed beyond 120 days after expiration shall incur fees equivalent to the total penalty plus the initial filing fee. Moreover, the application shall undergo initial filing and evaluation process

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