Duo Coronet importation to Spain - Customs issues

[Bennorca]

I have ordered the Duo Coronet from wellred.com.au - It is now blocked at Barcelona Customers for being a "medical device" which needs a special permit ("control de farmacia"). If I can't provide this permit, Customs says there is no way I can get the Cornonet.

Has anybody within the EU had similar issues or found a way around it?

Thank you!

[HekateMoon]

Hi Benorca. I received the coronet in Ireland with no issues. Podem parlar per DM.

[Bennorca in reply to HekateMoon]

Thanks a lot! Every country seems to have different importation requirements. Am in touch with a Customs Agent now.

[HekateMoon in reply to Bennorca]

Great! Because i was going to mention amazon sells a similar helmet for hair growth. If they can...why not the duo? Enjoy your coronet!

[Bennorca]

Interesting. Have you got a link or article number. That would help me very much.

[Bennorca]

Following up on this thread, I´d like to report how I finally (after over 4 weeks) came into possession of my Duo Coronet.

This information may be of interest to other buyers in Europe, especially in Spain. Since it does not apply to US, Australian or other overseas customers, I will not translate everything from Spanish.

The Barcelona DHL Customs Department sent the product back to Tasmania, as I – in their view – lacked the appertaining permission, in particular an import license for sanitary products.

Asked how I could proceed, they advised me to find a Customs Agent who might be able to help me (they graciously gave me 4 days for that).

I finally found Barcelona-airport based Tracosa.Com. They appeared to be quite helpful but were of the same opinion: Importation of the Coronet implied a series of preliminary steps (control de farmacia).

So I

- Signed an “autorización de despacho aduanero” for the Customs Agent (a simple step, but you need to have a digital certificate);

- Applied for an EORI number (Economic Operators’ Registration number)

- Got registered as a risk-handling person and

- Applied for an import license with the AEMPS, the “Agencia Española de Medicamentos y Productos Sanitarios” (Spanish Agency of Medicines and Medical Devices), who also “confirmed” that I needed a license (“La importación de productos sanitarios en España requiere la obtención de una licencia previa de funcionamiento otorgada por la AEMPS”. This came with a steep € 384,64 tax (which I hope to retrieve).

- They also asked for CE marking and a Certificate of Conformity.

I wanted the Coronet so I did all that, as far as I was concerned. Then came another 15-page AEMPS letter requiring me silly things like “technician’s curriculum vitae”, “installation plan”, “supervisor’s qualifications”, etc. etc.

I replied with a sharply-worded letter. The “installation site” being my head, and no supervisors being involved, this must be a gross misunderstanding.

Their answer:

“En relación a su consulta, le informo que este tipo de producto está incluido en el Anexo XVI del nuevo Reglamento 2017/745 del 5 de abril sobre los productos sanitarios, para los que hasta la fecha no se han desarrollado especificaciones comunes y para su importación en España no es necesario disponer de licencia previa de funcionamiento ni autorización por nuestra parte.

Póngase con el agente aduanero que le haya solicitado toda esa documentación, la cual es de aplicación para los productos sanitarios, pero no para los productos del Anexo XVI del Reglamento citado.”

Which basically means:

That the importation of Wellred’s Coronet falls under Regulation (EU) 2017/745 and does not require any special license or permit whatsoever!

The Customs Agent sent me a bill for €498,24, made up as follows:

- Gastos de llegada: € 70.00

- Intervención despachos aduanas importación: € 150.00

- IVA (llegada + despacho): €46.20

- Arancel: 0€

- IVA (21%) 232.04

I think that no Customs Agents needs to be involved, but these details might help any future buyer of the Coronet to smoothen and facilitate importation.

One last advice: Once the item has arrived at Customs, they ask you to confirm that the price is right and want a description of the product. Do NOT mention Parkinson’s and definitively do NOT claim that photobiomodulation will cure, or even help, any neuro-degenerative disease.

I had described the product as follows (but you may come up with a simpler version and not mention photobiomodulation at all):

“The Duo Coronet is a red-light helmet for non-invasive brain stimulation to help the brain develop new connections, improve cerebral blood circulation or regenerate damaged brain cells (the mitochondria = the energy-producing “batteries”).

Eight LEDs are positioned over the cranium. A series of mini-videos show how to set up the eight-leg Duo Coronet at home.

“Duo” refers to the two wavelengths of the LEDs: deep-red at 670 nm (visible to the naked eye), and near-infrared at 810 nm (not visible). Near-infrared light can penetrate the skull which is why this technology is also referred to as transcranial photobiomodulation.

The Duo Coronet’s program lasts for 24 minutes and then shuts off automatically (first 12 minutes of deep-red 670 nm, then 12 minutes of near-infrared 810 nm).”