Importing a medical device for personal use

[nikov]

Hi,

 

I did order an electronic muscle stimulator online for personal use. The device which I wanted wasn't available in Thailand and the shipment method was DHL and I couldn't affect it.

 

The package was catch by Thai FDA. They say that I would need a prescription to get the device delivered to me. DHL agrees with the FDA, even their customer support manager.

I do agree that it is classified by medical device, in Physical Therapy Devices category. However, it is an OTC product and doesn't require prescription (when buying inside Thailand).

 

I did try to look Medical Device Act B.E. 2551 (2008) http://www.fda.moph.go.th/sites/fda_en/Shared Documents/Med ACT_2008.pdf and nowhere in it seems to be a requirement that I would need a prescription when I order a medical device for personal use - which doesn't otherwise require prescription. But they have licensing requirements for companies who are importing and the whole document seems to be mainly about that.

 

Any ideas what I could do - other than to go to a hospital to get the prescription. I have delivered tons of documents already and kind of pissed off. Anybody has experience of solving this? I did find topics like people couldn't import condoms for personal use, that doesn't sound right.

 

The law should be the same if you carry the condoms or the medical device with you via airport and if you order the product online, right? If one goes to the red line in airport with condoms there is certainly no law which requires a prescription for those.

 

Any help appreciated. Is it possible to contact the FDA via email, or would it help if I visit their office?

[Sheryl]

From my experience you will not win on this and would do best to just refuse the shipment and let them destroy it or send it back. If you ever managed to get the various licenses (besides FDA license, which I don't think you can get, they will also demand an ekectrical safety inspection) it would take many, many months and you'll be charged customs storage fees for that time.

 

If you had not used a courier this likely would not have happened. In Thailand use if couriers like DHL, Fedex etc virtually gurantees such problems.

 

If you cannot find what you need in Thailand then find a way to buy it online and have it shipped by regular mail.

 

Only other option I can think of is to tell DHL you do not want them to handle customs clearance and will do it yoyrself. Then travel out to whatever customs location has it and try to clear it on your own. At least 50% odds you'll succeed, as soon as they see you are a private individual bringing in a small item of low value their interest level goes down. But be prepared for an exhausting day doing this as well as a possibly long distance trip. In addition it sounds like you already signed off on DHL handling the clearance and it may be hard to rescind this.

 

A prescription has nothing whatsoever to do with this and will not help in any way. What they are demanding is a commercial impirt lucense which you cannot get.

 

In future never, ever use a courier sevice for anything othet than documents.

 

Sent from my SM-J701F using Thailand Forum - Thaivisa mobile app

 

 

 

 

[BritManToo]

12 hours ago, nikov said:

The package was catch by Thai FDA. They say that I would need a prescription to get the device delivered to me. DHL agrees with the FDA, even their customer support manager.

Anything vaguely medical needs to be relabelled before shipping to Thailand.

If listed as 'home entertainment' it would have got through.

[Sheryl]

3 hours ago, BritManToo said:

 

If listed as 'home entertainment' it would have got through.

 

Probably not if sent by DHL.

 

At least not without electrical safety inspection (during the process of which, months pass and the whole thing falls into some sort of black hole) and stiff tariff, including stage charges for the months the "electrical safety inspection" took/.

[nikov]

3 hours ago, Sheryl said:

A prescription has nothing whatsoever to do with this and will not help in any way. What they are demanding is a commercial impirt lucense which you cannot get.

 

Sent from my SM-J701F using Thailand Forum - Thaivisa mobile app

 

 

Quote

 

 

Thanks Sheryl! The whole point of my post is that the FDA officer is requiring exactly a personal prescription from a doctor to use the device! :'D

 

Here is how it went: After many documents and Paperless importer registration the DHL requested a "medical certificate". I thought they meant a medical certificate, just like when you apply a work permit. So I did and got one! :'D Here is their answer, we had a long phone call too:
 

2nd mail "I mean please support for the letter why you have to use this product by doctor"
3rd mail "Following Thai Customs and FDA Department you have to support for the Medical certificate which explain why you have to use this product by doctor."
4th mail "you have to contact thai hospital for require POA(Prescription from doctor) for support clearance"
mail after our call: "As our last conversation, because doctor prescription from Clinic is doesn’t work due to doctor said that you are not Leprosy, Tuberculosis, Drug Addiction, Alcoholism, Elephantiasis so it’s don’t math with your Product. According from Local Thai customs regulation, you have to provide doctor prescription only from Hospital no clinic no pharmacy, so if you decide to go to hospital when you meet doctor please call me so I’ll explain to doctor about what tey have to write in the prescription. So any help you want please not hesitate to contact me"

The 4th email and email after the call are from DHL's "Clearance Support Team Leader – Customs Clearance".

So not only they require a prescription to use that device from a doctor. The doctor must work in a hospital - not in a clinic! Haha. I don't know if I should cry or laugh.

[Sheryl]

It will go on and on like this and likely never get through customs.

 

DHL is like this.

 

There is nothing I am aware of in Thai law that requires a presecripoion for this sort of devise but there are laws that prohibit importation of pharmaceuticals and medical devices except by companies with import permits from the FDA.

 

I suspect that DHL staff are not correctly understanding what customs is saying to them. It is not a doctor prescription that is being sought but paperwork from a hospital indicating the hospital as the importer. You are not going to get that.

 

Again, I suggest you either refuse the shipment or go clear it yourself.

 

If it has been at customs  more than 30 days you will be charged a storage fee.

[nikov]

Thanks Sheryl, appreciated.

Btw. I have lately went through many posts regarding best surgeons for a specific problem and the best insurance plans. Your answers have been extremely helpful for all of those!

[NancyL]

Sheryl, just a point of clarification about the only thing that will go thru customs duty-free via DHL being documents.  Recently, Hubby and I ordered some large maps from National Geographic in the U.S. with a view to getting them framed to use as artwork in our condo remodeling project. 

 

Despite requesting shipment via the U.S. Postal Service, we learned they were too large to ship via USPS and reluctantly agreed to DHL, labeled as "maps".  Amazingly they came to us without duty, despite clearly having been opened and inspected by Thai customs.  I figured they'd at least want to charge duty on the cost of the shipping.  In the past we've forwarded mail and magazines from the U.S. via DHL without duty, so I guess Thai customs puts maps in the same category.  I wonder about books?

[eezergood]

On 6/2/2019 at 2:14 PM, nikov said:

Thanks Sheryl, appreciated.

Btw. I have lately went through many posts regarding best surgeons for a specific problem and the best insurance plans. Your answers have been extremely helpful for all of those!

Have it sent to another location & collect yourself, SIngapore or Malaysisa for instance?