THAILAND: Thai FDA Amends the Medical Device Evaluation Fees for 2021 – November, 2021
2021-11-24
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
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LIST
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ITEM
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UNIT
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CHARGE RATE (THB)
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|
1
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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:
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medical device class 4
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1
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53,000
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medical device class 3
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1
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38,000
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medical device class 2
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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:
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medical device class 4
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1
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30,000
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medical device class 3
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1
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24,000
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medical device class 2
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1
|
|
1.3 Assessment of a request for permission to advertise a medical device that requires experts to evaluate academic documents
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1
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16,000
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|
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
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Letter of Product diagnosis
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1
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30,000
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Letter of Medical Device Risk Classification
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1
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10,000
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Letter of Grouping of Medical Devices
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1
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10,000
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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.
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1
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15,000
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LIST
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ITEM
|
UNIT
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CHARGE RATE (THB)
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|
2
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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
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2.1.1 To issue a R and renewal
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1
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12,000
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2.1.2 To consider changing the particulars in the registration manufacturing establishment certificate
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a). To increase production
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1
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12,000
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b). To change production location
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1
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12,000
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c). Medical device storage (Warehouse) (add/move/change)
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1
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6,000
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d). other cases requiring inspection at the place of production
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1
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12,000
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2.2 Assessment for issuing an import establishment registration certificate
or sales license including considering the changes in the list and renewal
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2.2.1 To issue an import business registration certificate and renewal
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1
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12,000
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2.2.2 To issue a sales license and renewal
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1
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3,000
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2.2.3 To consider changing import establishment registration certificate or sales license
a). import establishment registration certificate
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a1). To increase production
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1
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12,000
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a2). To change production location
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1
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12,000
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a3). Medical device storage (Warehouse) (add/move/change)
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1
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6,000
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a4). other cases requiring inspection at the place of production
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1
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12,000
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b). sales license
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|
|
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b1). To increase production
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1
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3,000
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b2). To change production location
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1
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3,000
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b3). Medical device storage (Warehouse) (add/move/change)
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1
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3,000
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b4). other cases requiring inspection at the place of production
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1
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3,000
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2.3 Assessment for issuing certificate of compliance (COC) and Good Manufacturing Practice (GMP)
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2.3.1 Assessment for Quality system /document evaluation /Paper by specifying the rate of risk classification of the production scope as follows:
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medical device class 4
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1
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28,000
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medical device class 3
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|
medical device class 2
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|
medical device class 1
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2.3.2 Assessment for issuing a certificate in accordance with GMP rules; including monitoring and check for renewal
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A). Production location based in Thailand
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1
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18,000 THB/person/day
total not more than
360,000 THB/request
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b). On-site GMP inspection at the overseas manufacturers
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- The production site is in ASEAN countries
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1
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27,000 THB/person/day
total not more than
540,000 THB/request
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- The production site is NOT in ASEAN countries
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1
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36,000 THB/person/day
total not more than
540,000 THB/request
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2.4 Assessment in country (THAILAND) for issuing Good Distribution Practice for Medical Devices (GDP)
|
1
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18,000 THB/person/day
total not more than
272,000 THB/request
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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
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|
2.6 Assessment for issuing Good Clinical Practice for Medical Devices (GCP) (Protocol + Site visits)
|
1
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25,000 THB/person/day
total not more than
404,000 THB/request
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Account 2: Any consideration or assessment other than Account 1
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ITEM
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UNIT
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CHARGE RATE (THB)
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1. assessment and search of documents related to permission
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a). authorized production site layout
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per page
(Not exceed 8 pages/item)
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250 THB
(Total Not more than 2,000 THB)
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b). other documents
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per page
(Not exceed 40 pages/item)
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50 THB
(Total Not more than 2,000 THB)
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2. Consideration of the discussion or general information service by replying as a letter
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1 request
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1,500 THB
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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)
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3.1 Diagnose the product it the product is a medical device or not
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1 request
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500
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3.2Risk classification
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1 request
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500
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3.3 Grouping
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1 request
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500
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4. Consideration of device labelling or documents by replying as a letter
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4.1 In case of NOT sending it to a specialist for evaluation or examination
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1 request
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2,000
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4.2 In case of sending it to a specialist for evaluation or examination
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1 request
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15,000
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5. Specialized technical advice on medical devices
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5.1 Production or importation of medical devices for research and development and related laws
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a). project consultation
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1 Project
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100,000
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b). one time consultation
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1 time
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2,000
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5.2 production site and quality system, importation, sales, and related laws
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a). production site layout and good manufacturing practice
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1 time
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20,000
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b). Layout of place of import or sale
and quality system rules for importing or selling
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1 time
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10,000
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c). products and medical device standards, requesting permission
Listing, Notified medical device, request for waiver, requested documents and relevant laws
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1 time
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2,000
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d). Advertising of medical devices Permission and related laws
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1 time
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1,500
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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)
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1 time
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500
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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
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1 request
|
300
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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
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1 request
|
600
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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).
Translated by
References:
Thai FDA Medical Device Evaluation Fee Amendment Account (1) & (2) 2021
