Thailand - Certificate of Free Sale Alternatives

E

esh14

#11
Hi, I am from Singapore. I would like to know if we approach our Authorized Representative from EU to get the Certificate of Free Sales for us... Then for the legalization of the document, should we do it in the EU countries or we must do it locally, means in Singapore. Please advise. HELP!!!
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#12
Hi, I am from Singapore. I would like to know if we approach our Authorized Representative from EU to get the Certificate of Free Sales for us... Then for the legalization of the document, should we do it in the EU countries or we must do it locally, means in Singapore. Please advise. HELP!!!
Hi,

The use of the phrase "our Authorized Representative from EU" indicates that you manufacture somewhere outside the EU snd are interested in selling into the EU; in that case you don't require "the Certificate of Free Sales", but the EC certificate according to the MDD (unless it's a class 1 device).

If, on the other hand, you're importing a device made outside Singapore into Singapore, you have to be in full compliance with Singapore's regulations. If you need a the Certificate of Free Sales, you should ask the manufacturer for it.

Cheers,
Ronen.
 

sreenu927

Quite Involved in Discussions
#13
Hi esh14,

Would you be more clear on your question, so that our forum can help you answering correctly!

If your product is manufactured in Singapore and is a medical device, you can get the FSC from HSA, Singapore. For this, you need seek a FSC Request Letter from the importing Country and other docs such as label, user guide, etc...This takes 14 working days and S$100 fees.

If your product is a non-medical device manufactured in Singapore, you can get the CFS (FSC) from Singapore Customs. For this you need to provide a local sales invoice (showing evidence that the product is sold in SG).
This will take 5-7 working days and S$4.00 (Four dollars)Fees.

If your product is not from Singapore, you need to get a FSC from the manufacturing Country!

Regards,
Sreenu
 
E

esh14

#14
Hi Ronen and Sreenu, thank you for the reply. Sorry for not stating clearly in my earlier post.
My company has a few medical devices that are manufactured in Singapore and have been CE-marked lately by EU countries.
We want to import to Thailand and I understand that we need to do registration with Thai FDA.
So, we intend to get the Certificate of Free Sales from EU countries since we can?t get from the local authority (eg HSA Singapore as still in the process of registration, not listed at SMDR).
Therefore, I would like to ask in this case, should we approach Royal Thai Embassy from Singapore or EU countries to do the apostille/legalization for the Certificate of Free Sales that will be issued by EU?
 

sreenu927

Quite Involved in Discussions
#15
What is the classification in Singapore?

May be you can request HSA about the Thai Registration and requirement of FSC with CE Marking approval as supporting docs (although you might submitted all these for your abridged approval to HSA).

Else, if Thai FDA accepts FSC from other registered country (UK/EU) and EU Member State Country is ok to issue FSC, then you can seek your ECREP help to get this done and also legalized (if required) by Thai Embassy in EU Member State itself!

First seek the alternative doc acceptable by Thai FDA from your Thai counterpart (distributor or so..) and then approach your EC REP in EU to check the feasibility.
If not, then you may need to wait until the product is registered in Singapore.


Regards,
Sreenu
 
E

esh14

#16
Our kits are classified as Class C and D in Singapore.
I have checked with HSA Singapore before and I was told that they cant issue any FSC to us until the product is listed on SMDR. As now the kits are still under evaluation, and we need to do the registration as soon as possible. So another alternative is to get the FSC from our Authorized Representative in EU countries (higher cost) since the kits are CE-marked. Just that I need to find out information for the legalization for the document. See if we must get notary public or embassy to do locally or from EU countries.
 

Ronen E

Problem Solver
Staff member
Moderator
#17
According to the 1st post on this thread,

Thailand requires certificates of free sale from the country of origin (i.e. where the devices are actually produced, not where the manufacturer is). The only other alternative given to me by our local contact is to get a letter from the chamber of commerce in the country of origin, listing the devices made there.
So not sure a CFS from the EU would help.

Have you already exhausted all the suggestions others have made in this thread?
 
E

esh14

#18
Yes. I have tried but still pending for confirmation. Anyone has Thai authority contact that can response to my question?
 

sreenu927

Quite Involved in Discussions
#19
Ms. Yuwadee Pattanawong - Director of Medical device Control division, Thai FDA. Her e-mail i.d is as below:
[email protected]

As an alternative to FSC, Thai FDA may also consider "Certificate of Quality Management System" from the Manufacturer, which is nothing but ISO 13485 Certificate. So you can try submitting ISO 13485 cert and to boost up the supporting docs, also submit your NB issued EC Certificate for quality system.

But again, it's a try you ask your importer/distributor in Thailand. From my view, this is applicable to General Medical devices (Class III as per Thai FDA Classification, low risk); not sure whether applicable to Notified and Licensed Medical devices.

Give a try both ways - through importer and writing to above e-mail.

Regards,
Sreenu
 
Thread starter Similar threads Forum Replies Date
T Free Sale Certificate - China, Vietnam, Philippines and Thailand Other Medical Device Regulations World-Wide 8
T Thailand reg- Certificate of Free Sale from legal manufacturer or manufacturing site? Other Medical Device Regulations World-Wide 4
L Free Sale Certificate (FSC) in different language for Thailand Other Medical Device Regulations World-Wide 2
L Exportation Certificate vs. Free Sale Certificate (FSC) in Thailand Other Medical Device Regulations World-Wide 2
J In-Country Representative - Thailand Other Medical Device Regulations World-Wide 7
supadrai Aviation MRO Project facility coming to U-Tapao airport in Thailand - Help Career and Occupation Discussions 2
M Information about the registration of a Medical Device in Thailand Other Medical Device Regulations World-Wide 2
W Question on Research Use Only (RUO) products into Indonesia, Philippines and Thailand Other Medical Device Regulations World-Wide 2
P Thailand Medical Device Labeling Content Requirements Other Medical Device Regulations World-Wide 3
J Rayong Thailand - Best Hotel and closest international Airport Travel - Hotels, Motels, Planes and Trains 3
K Thailand Medical Device Registration - Transfer importer Other Medical Device Regulations World-Wide 1
G Validity for Thailand Medical Device License and can change Distributor thereafter? Other Medical Device Regulations World-Wide 3
E Automotive: Local Content Suppliers in Morocco, Thailand, Brazil, and India Misc. Quality Assurance and Business Systems Related Topics 2
L Pre-Clinical Studies for Medical Devices in Thailand Other Medical Device Regulations World-Wide 2
L Special Medical Device Labeling Requirements in Thailand Other Medical Device Regulations World-Wide 5
J Business Continuity Planning - Experiences related to Thailand's flooding Business Continuity & Resiliency Planning (BCRP) 5
L ICH format on Malaysia and Thailand Other Medical Device Regulations World-Wide 1
L Thailand Medical Device Registration Requirements Other Medical Device Regulations World-Wide 4
D Implantable Medical Device (Silicone Implant) Regulations for Thailand & Mexico Other Medical Device Regulations World-Wide 13
Ajit Basrur Regulatory requirements for export of Medical Devices to Thailand, Australia and US ISO 13485:2016 - Medical Device Quality Management Systems 5
G QA or Lean opportunity in Thailand? How to find... Career and Occupation Discussions 2
A Help Locate Calibration Services in Thailand General Measurement Device and Calibration Topics 3
S What if a nation like Thailand adopts ISO 9001 as a national standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Medical device certificate in Australia - ARTG certificate Other Medical Device Regulations World-Wide 0
S Certification Body Changeover - Transfer of Certificate Registrars and Notified Bodies 9
J How to keep MDD certificate valid when legal manufacturer has liquidity problem EU Medical Device Regulations 0
D ISO 17021 Certificate Registrars and Notified Bodies 1
B Free Sales Certificate for Non Medical Devices Other Medical Device Related Standards 2
Louddogsbark When your 13485:2016 certificate has been pulled ISO 13485:2016 - Medical Device Quality Management Systems 2
lanley liao The validity of API Spec Q1 certificate Oil and Gas Industry Standards and Regulations 2
B Countries with no need for FSC (Free sales certificate) Other Medical Device Regulations World-Wide 0
M Calibration Certificate Result issued by an accredited external laboratory General Measurement Device and Calibration Topics 9
U Certificate of Free Sale Other US Medical Device Regulations 7
A Scope of ISO 13485 certificate ISO 13485:2016 - Medical Device Quality Management Systems 1
D ISO 9001 certificate issued by QMS International for 10 years - legit? Registrars and Notified Bodies 17
E Adding models to an approved Russian Registration Certificate Other Medical Device Regulations World-Wide 1
S Philippines CMDL (Certificate of Medical Device Listing) Elsmar Cove Forum ToS and Forum Policies 0
A Is it mandatory to obtain ISO13485 certificate prior to CE marking? EU Medical Device Regulations 8
R External Audit and Certificate prorogation due to the pandemic General Auditing Discussions 10
A How to make sure whether the predicated device is marked with EC certificate? EU Medical Device Regulations 8
I Is the contract mfg. mentioned in legal manufacturer EC certificate? CE Marking (Conformité Européene) / CB Scheme 4
SocalSurfer AS9100 new certificate, but need QMS software, help Quality Assurance and Compliance Software Tools and Solutions 2
C Certificate of Conformance Form - COC for each customer a controlled document? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
B Certificate Suspension? Shut down due to Covid-19 IATF 16949 - Automotive Quality Systems Standard 14
L Appears to be a certificate mill certificate ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
D ISO 9001 & AS9100 Certificate issued by a consultant for a Distributor Registrars and Notified Bodies 11
J CE Certificate and additional processing EU Medical Device Regulations 4
bryan willemot Chemical / physical certificate of conformance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
B IATF certificate suspended - Who do we notify? IATF 16949 - Automotive Quality Systems Standard 6
F Calibration certificate content - Average Value and True Value ISO 17025 related Discussions 6

Similar threads

Top Bottom