Medical Device Registration Requirements in ASIAN Countries

[LQ. Fanny Lozano]

Hello!!

I recently joined the forum cause I really need help with some specific questions I have for general Medical devices registration (Peritoneal Dialysis equipment, catheters and solutions) in Singapore, Malaysia and Thailand. I'm kind of upset cause none of the respectively web pages for each of this countries has solved my doubts and I need to know in order to proceed my registration. So I would really appreciate any help on the following:

1. Talking about a Dialysis equipment, together with 2 catheters types (straight and pig tail) and 2 dialysis solutions each of different calcium concentration and a disinfectant solution fthat is necessary for the process: Could I consider ALL of these products as a SYSTEM (according to HSA Singapore grouping system) for the submission of the dossier or shall I submit them each one by separate?

2. Talking about the dossier organization: Does the legal documents (Free Sale Certificate, Authorization letters, GMP’s, etc.) have a special part within the CSDT format?

3. About labelling: Could I use my trademark names for my products in ALL of their labels (even they don’t have translation on the original language) or shall I use generic names?

4. Talking about the dialysis solutions: Their active principles are mostly salts, which often are used as excipients for other drug products and because of that their manufacturers do not give a GMP certificate so, What other alternative document is valid for supporting the quality of my active principles?

Thank you so much for your valuable help!!

 

[Stijloor]

Are there any Members with this specific type of expertise who are willing to help?

Thank you!!

Stijloor.

 

[LQ. Fanny Lozano]

Thanks Stijloor for the support!!

Well, I guess there are too many questions which are very specific and could be a little bit hard to solve....but any way, If there is SOMEONE who has already submit an import register for any kind of Medical Device to Singapore, Malaysia or Thailand, I'd really appreciate any kind of valuable information about the protocol they followed in order to obtain the permit. That is because it is the FIRST time we try to import to the ASEAN community and sometimes the information they present on their web links isn't clear enough.

If you want to share any kind of experience I'll be very gratefull to you. Thanks!!

 

[Marc]

Another quick "Bump". Can anyone help with this one? Please - Help if you can. My Thanks in advance!

Also see: Medical Device Importation into ASEAN Community

 

[Ronen E]

Thanks Stijloor for the support!!

Well, I guess there are too many questions which are very specific and could be a little bit hard to solve....but any way, If there is SOMEONE who has already submit an import register for any kind of Medical Device to Singapore, Malaysia or Thailand, I'd really appreciate any kind of valuable information about the protocol they followed in order to obtain the permit. That is because it is the FIRST time we try to import to the ASEAN community and sometimes the information they present on their web links isn't clear enough.

If you want to share any kind of experience I'll be very gratefull to you. Thanks!!

Exactly.

Your questions are very specific so I doubt anyone would readily have the answers. Please bear in mind that (at least AFAIK) there is no cohesive regulatory system for the ASEAN group. I think it is more a trade / cooperation organisation than a really integrated market like the EC. IMHO Singapore regulation is quite clear and elaborated, and a lot of information is available on-line; Malaysia has a more basic system established with some information available on-line, however, significant portions are only available in local language; Thailand, as much as I gathered, currently has the most basic system of the three. ASEAN includes other countries as well, with regulatory systems levels varying from none to fair. As far as I'm aware, the Singaporean system is the closest among ASEAN countries to standards common in GHTF founding countries.

I reckon that you either need to do your best on your own, perhaps with some translators / locals help, or hire some specialist to seriously study your case details and walk you through the entire process.

If I had to deal with a similar situation, I would go first for clearance in Singapore, then I would look at other markets; that being said, I don't know your commercial constraints.

Good luck,
Ronen.

 

[LQ. Fanny Lozano]

Thanks for the advice Ronen, actually I'm starting to get to the point of all this cases. As you said, all the members of the ASEAN community even though have their own guidelines and requests for submitting registers. Anyway, Singapore is the strictest of the three and their guides are quite helpful but still do not describe those kind of little details but I decided to have a direct contact so they can clear this particular things.

So kind for sharing your point of view, regards!

 

[sreenu927]

Hi
Pls see my respones below in blue.

1. Talking about a Dialysis equipment, together with 2 catheters types (straight and pig tail) and 2 dialysis solutions each of different calcium concentration and a disinfectant solution fthat is necessary for the process: Could I consider ALL of these products as a SYSTEM (according to HSA Singapore grouping system) for the submission of the dossier or shall I submit them each one by separate?
Instrument+catheter+solution = SYSTEM.
If all your catheters and solutions are used in combination to intended use of the instrument, then it is System. For Catheters, if the customer has choice to select one of the catheter types and solutions, it is a Family.

2. Talking about the dossier organization: Does the legal documents (Free Sale Certificate, Authorization letters, GMP’s, etc.) have a special part within the CSDT format?

While compiling CSDT, in the executive summary or at Manufacturer Information, you can provide ISO 13485Cert as an Appendix.

The authorisation letters don;t have any reference with the CSDT. However, in a final section of List of Appendixes, you can reference all authorization letters and FSC. Most of the time, FSC may not be required for submission in SG.


3. About labelling: Could I use my trademark names for my products in ALL of their labels (even they don’t have translation on the original language) or shall I use generic names?
You need to indicate the product name, as per the label and can use the same original label. Generic names are not allowed.
English language is accepted for SG, no translation is required.

4. Talking about the dialysis solutions: Their active principles are mostly salts, which often are used as excipients for other drug products and because of that their manufacturers do not give a GMP certificate so, What other alternative document is valid for supporting the quality of my active principles? ISO 13485 Certificate will do.

Regards,
Sreenu

 

[sreenu927]

In Malaysia,

Currently the regulations bill is yet to pass in Parliament.

The registration schems is voluntary now. You can create a user name and log in with your & company details and do a voluntary registration.
No documentation is required at this momet and no fees.
Vigilance activities apply.

Thailand:
For Class III(low risk), an FSC will do.
For Class II(pre-market notification) and Class I(high risk--pre-market license approval), the following are required:
--product name in Thai
--category and type (classification)
--characteristics of the device
--packaging info
--raw material and qty
--storage requirements
--shelf-life (stability test report)
--QCtesting/final QA/AC inspection report
--name and address of the manufacturer and/or importer
--label
additional following for Class I are required:
--premises and warehouse info(location map and adjacent structures)
--license operator(importer): ID copy, health caer, business docs(ACRA/RCB)
--IFU/User Guide

Regards,
Sreenu

 

[LQ. Fanny Lozano]

Thank you Screenu927!! I really appreciate your time for reply cause now I got it very clear, that were the answers I've been waiting for!
Best regards!

 

[MC2012]

Thank you for the information stated above specifically:

"While compiling CSDT, in the executive summary or at Manufacturer Information, you can provide ISO 13485Cert as an Appendix." and
"The authorisation letters don't have any reference with the CSDT. However, in a final section of List of Appendixes, you can reference all authorization letters and FSC. Most of the time, FSC may not be required for submission in SG."

I am new to the regulatory world. My company is trying to register an FDA-approved Class I (low risk) medical device (medical grade digital video recorder) in Malaysia and Singapore. We also have ISO13485 certification and CE Marking.

1. Is there a simplified CSDT format that I can use?
2. Is there a Declaration of Conformity template that I should use?
2. Can a Certificate of Foreign Government (CFG) (obtained from the US FDA) be substituted for the Certificate of Free Sale (CFS)? I'm somewhat confused as the CFS in the United States is given for Food, while the CFG is given for medical devices.

Thank you for any guidance.

MC2012