No.

Procedure

Duration

Responsible department

1.

Submission

1. Applicant medical device product diagnosis submission
2. Division administrative officer issued submission payment invoice
3. Applicant proceed submission fee payment. Attached payment receipt with the submission documents.
4. Division administrative officer issued ThaiFDA appointment letter.

15 minutes

One Stop Service & Consultation Center (OSSC)

2.

Documents Checking

Specialist check documents

1. In case of correct and complete documents

               Specialist issued appointment letter for the retrieval of result letter. Also notify applicant for fees that have to be paid.

2.  In case of incorrect and incomplete documents Specialist noted the deficiencies, then the administrative officer notify applicant. Applicant once acknowledged the defect must signed to receive the copy of defected documents.

10 working days

Medical Device Control Division

3.

Documents review

Document reviewer recorded into database, and issued medical device diagnosis certificate, along with requesting signature of:

1. In case of no specialist/committee approval
2. In case of specialist/committee approval

7.5 working days

87.5 working days

Medical Device Control Division

4.

Signing/Committee approval

Review diagnosis result and sign on medical device diagnosis certificate.

2 working days

Medical Device Control Division

5.

Receiving Document       

1. Division administrative officer inform the applicant once the documents review procedure is completed.
2. Applicant present appointment letter for the retrieval of result letter at One Stop Service & Consultation Center (OSSC)
3. Division administrative officer issued certificate payment invoice. Applicant then use the copy of the receipt to retrieve certificate.

15 minutes

One Stop Service & Consultation Center (OSSC)

No.

Names  and required amount of document                                               Additional detailed (if any)

Government department  that issued documents

1.

Procedure control form for medical device  product diagnosis;

Medical Device Control Division

2.

Document checklist form for medical device  product diagnosis 1 original copy

Medical Device Control Division

3.

Letter requesting for medical device  product diagnosis

1 original copy

-

4.

Documents for medical device  product diagnosis

1 original copy

-

5.

Company certificate

1 copy ( Authorized person must sign and seal on every pages)

Department of Business Development (DBD)

6.

6.1 LOA (Letter of Authorization)

1 original copy

• For single submission , please stick THB 10 revenue stamp
• For multiple submission, please stick THB 30 revenue stamp, with 1 year validity. Copy for certified LOA by officer must be present for other submissions

6.2 Copy of ID card ( both parties of authorized person and person who gave authorization)

No.

Fee description

Fee (THB)

1.

Medical device product diagnosis request (Submission fee)

100

2.

Medical device product diagnosis certificate

500

3.

Attached account file of the announcement of the Ministry of Public Health regarding the expenses to be collected from the applicant in the process of considering the approval of medical device products 2017

Account No.1 Document review by expertise and establishment review Item 1 (4) Assessment in accordance to request, medical device product diagnosis certificate, risk control or medical device classification and grouping

Account No.2 Others review apart from account no.1

Item 3 (1) Determining whether or not  the product is a medical device

38,000 / request

3,000 / request