Vastuskiri

Dear Ms. Chen,

Thank You for Your inquiry.

According to Estonian Medical Devices Act § 26 (4), every undertaking who distributes on the market of Estonia a class IIa, IIb, or III medical device classified according to Council Directive 93/42/EEC concerning medical devices, shall notify the Health Board thereof 10 days after distribution of the relevant medical device for the first time.

The Health Board can be notified via Estonian Medical Device Database (EMDDB).

Please note that for actors outside of Estonia, the account for the notification in the EMDDB is made manually by the Health Board. For creating an account, please provide us the contact person’s full name, e-mail and the position in the company.

Additionally, the access to the database is limited to the users, who reside outside of Estonia. To resolve this, please contact [email protected] with a request to access the database an provide your IP address. They will white-list Your IP, which should give You the access to the database.

Further EMDDB instructions for use are found on the database homepage under „Forms“.

For contact lenses, the general documents needed would be:
1. Declaration of Conformity,
2. EC certificate,
3. Original layout of the packaging or photos of the packaging from each side. Text on packaging/labelling in other language than Estonian should be translated.
4. Original copy of instructions for use (IFU). IFU in other language than Estonian should be translated. 
5. Any other relevant documentation necessary. We will inform you if there are any further information we need.

There are no fees to register Your device in the EMDDB.

Generally, we will review your application within 10 days.

For any further questions, do not hesitate to contact us again.

All the best,

Dear Sir,

Good Day!!

We are a manufacturer of contact lenses in Taiwan, and we have already passed the MDD and obtained the CE certificate.

We understand that registration is required in Estonia for sales.

Could you please provide information on the required documents, timeline, and costs for registration in Estonia?

Look forward to your reply.

Thanks for your help!

Best regards,

Katherine Chen 陳永淳

Innova Vision Inc. 昱嘉科技股份有限公司

Regulatory Affairs法規認證課

2F., No. 20, Prosperity Rd. 1, Hsinchu Science Park 300091, Hsinchu, Taiwan

300091新竹科學園區展業一路20號2樓

Tel: +886-3-592-7299 #867

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