- Medical Device Act BE 2551 (2008)
- Duties and responsibility of applicant
2.1 Applicant must understand, have the best knowledge of the details of the medical device that is being register as well as being aware of the legal requirements in relation of submission for medical device product diagnosis
2.2 Applicant must prepare document and related evidence in accordance to the requirement of the checklist of medical device product diagnosis form.
2.3 Any claim of intended use, must be supported with technical documents. Applicant must provide and able to clarify related information of medical devices that wishes to submit for medical device product diagnosis.
Timeline, Procedures and responsible department
Duration of procedure: 10 working days without specialist/committee approval; 90 working days with specialist/committee approval
No. |
Procedure |
Duration |
Responsible department |
1. |
Submission
|
15 minutes |
One Stop Service & Consultation Center (OSSC) |
2. |
Documents Checking Specialist check documents
Specialist issued appointment letter for the retrieval of result letter. Also notify applicant for fees that have to be paid.
|
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:
|
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
|
15 minutes |
One Stop Service & Consultation Center (OSSC) |
List of required documents. Note: No1-4 required 1 original copy of the documents
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
6.2 Copy of ID card ( both parties of authorized person and person who gave authorization) |
|
Fees
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 |
Remark: Timeline of duration procedure referred to only the case of complete and correct documents not the case incomplete and incorrect documents or the explanation of the specialist/committee team.