Overview

Since the costs to be collected from applicants in the medical device product licensing process are not appropriate for the current situation, it is expedient to determine the expenses in the review process to generate efficient management.

The recurrent fee will be determined into 2 accounts—(1) Assessment of academic documents and inspection the establishment and (2) Any consideration or examination other than Account 1.

Exemptions and Waivers

The FDA allows the applicants for medical device product approval to be exempted from all expenses if the device is for research and development purposes and related laws. Refer to item 5 in list 2 provided in the table. 

Amended Fee

This Notification shall be effective from the day following the date of its publication in the Government Gazette – 9 AUG 2021. The former announcement shall be dismissed. 

 

For the updated fee, see below:

Account 1: Assessment of academic documents and inspection the establishment

LIST

ITEM

UNIT

CHARGE RATE (THB)

1

Evaluation of academic documents on medical devices

1.1 Assessment of a request for a license to produce or import and request for a notification of Notified Medical Device that requires an expert to assess the technical documentation by stipulating the rates according to the risk level of the product as follows:

medical device class 4 

1

53,000

medical device class 3

1

38,000

medical device class 2

1

1.2 Assessment of a request for amendment of the change notification or Notified Medical Device that require experts to evaluate academic documents divided by risk classification which are not for Non-IVD and IVD as follows:

medical device class 4

1

30,000

medical device class 3

1

24,000

medical device class 2

1

1.3 Assessment of a request for permission to advertise a medical device that requires experts to evaluate academic documents

1

16,000

1.4 Assessment of a request for letter of product diagnosis that require experts to evaluate academic documents divided by risk classification or grouping of medical devices

Letter of Product diagnosis 

1

30,000

Letter of Medical Device Risk Classification 

1

10,000

Letter of Grouping of Medical Devices

1

10,000

1.5 Assessment as requested under section 27 of the Act 2008 and its amendments or any other request that require experts to evaluate or inspect, such as manufacturing or importing medical devices for research studies, etc.

1

15,000

LIST

ITEM

UNIT

CHARGE RATE (THB)

2

Evaluation for registration of medical device establishment and quality system certification

2.1 Assessment for issuing a production establishment registration certificate

  including to consider the change notifications and renewal 

2.1.1 To issue a R and renewal 

1

12,000

2.1.2 To consider changing the particulars in the registration manufacturing establishment certificate

a). To increase production

1

12,000

b). To change production location 

1

12,000

c). Medical device storage (Warehouse) (add/move/change)

1

6,000

d). other cases requiring inspection at the place of production

1

12,000

2.2 Assessment for issuing an import establishment registration certificate

or sales license including considering the changes in the list and renewal

2.2.1 To issue an import business registration certificate and renewal

1

12,000

2.2.2 To issue a sales license and renewal

1

3,000

2.2.3 To consider changing import establishment registration certificate or sales license

a). import establishment registration certificate

a1). To increase production

1

12,000

a2). To change production location 

1

12,000

a3). Medical device storage (Warehouse) (add/move/change)

1

6,000

a4). other cases requiring inspection at the place of production

1

12,000

b). sales license

b1). To increase production

1

3,000

b2). To change production location 

1

3,000

b3). Medical device storage (Warehouse) (add/move/change)

1

3,000

b4). other cases requiring inspection at the place of production

1

3,000

2.3 Assessment for issuing certificate of compliance (COC) and Good Manufacturing Practice (GMP)

2.3.1 Assessment for Quality system /document evaluation /Paper by specifying the rate of risk classification of the production scope as follows:

medical device class 4 

1

28,000

medical device class 3

medical device class 2

medical device class 1

2.3.2 Assessment for issuing a certificate in accordance with GMP rules; including monitoring and check for renewal

A). Production location based in Thailand

1

18,000 THB/person/day

total not more than

360,000 THB/request

b). On-site GMP inspection at the overseas manufacturers

    - The production site is in ASEAN countries

1

27,000 THB/person/day

total not more than

540,000 THB/request

    - The production site is NOT in ASEAN countries

1

36,000 THB/person/day

total not more than

540,000 THB/request

2.4 Assessment in country (THAILAND) for issuing Good Distribution Practice for Medical Devices (GDP)

1

18,000 THB/person/day

total not more than

272,000 THB/request

2.5 Assessment for issuing Primary Good Distribution Practice for Medical Devices (Primary GDP)

1

18,000 THB/person/day

total not more than

108,000 THB/request

2.6 Assessment for issuing Good Clinical Practice for Medical Devices (GCP) (Protocol + Site visits)

1

25,000 THB/person/day

total not more than

404,000 THB/request

Account 2: Any consideration or assessment other than Account 1

ITEM

UNIT

CHARGE RATE (THB)

1. assessment and search of documents related to permission

a). authorized production site layout

per page

(Not exceed 8 pages/item)

250 THB

(Total Not more than 2,000 THB)

b). other documents 

per page

(Not exceed 40 pages/item)

50 THB

(Total Not more than 2,000 THB)

2. Consideration of the discussion or general information service by replying as a letter

1 request

1,500 THB

3. Product diagnosis, Risk classification and medical device grouping replying as a letter (In case of NOT sending it to a specialist for evaluation or examination)

3.1 Diagnose the product it the product is a medical device or not

1 request

500

3.2Risk classification 

1 request

500

3.3 Grouping

1 request

500

4. Consideration of device labelling or documents by replying as a letter

4.1 In case of NOT sending it to a specialist for evaluation or examination

1 request

2,000

4.2 In case of sending it to a specialist for evaluation or examination

1 request

15,000

5. Specialized technical advice on medical devices

5.1 Production or importation of medical devices for research and development and related laws

a). project consultation

1 Project

100,000

b). one time consultation

1 time

2,000

5.2 production site and quality system, importation, sales, and related laws

a). production site layout and good manufacturing practice

1 time

20,000

b). Layout of place of import or sale

  and quality system rules for importing or selling

1 time

10,000

c). products and medical device standards, requesting permission

Listing, Notified medical device, request for waiver, requested documents and relevant laws

1 time

2,000

d). Advertising of medical devices Permission and related laws

1 time

1,500

6. Assessment for recording of the request in the E-submission system (In case would like the FDA staff to record the information in system)

1 time

500

7. Assessment of information on request for registration of medical device manufacture and renewal requests by grouping as follows:
    - Single request

    - Family per request

    - System per request

    - IVD test kit per request

    - IVD cluster per request

    - Group/Set

1 request

300

8. Assessment of information on request for registration to import medical device manufacture and renewal requests by grouping as follows:
    - Single request

    - Family per request

    - System per request

    - IVD test kit per request

    - IVD cluster per request

    - Group/Set

1 request

600

The fees exclude the following:

(1)  the cost of searching service, transporting documents and rental fee for collecting document from the Food and Drug Administration,

(2) copying of documents,

(3) traveling fee, and

(4) Excluding accommodation fee in case on in section outside country (Thailand).

 

  

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References:
Thai FDA Medical Device Evaluation Fee Amendment Account (1) & (2) 2021

 

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