Implantable Medical Device (Silicone Implant) Regulations for Thailand & Mexico

D

danush

Guest
#1
Will appreciate any information about medical device regulations in Thailand. Our company developed a silicone implant for long-term use and is intrested in receiving regulatory approval in Mexico and Thailand.
 

Ajit Basrur

Admin
Staff member
Admin
#2
Re: Medical Device (silicone implant) Regulations for Thailand & Mexico

Will appreciate any information about medical device regulations in Thailand. Our company developed a silicone implant for long-term use and is intrested in receiving regulatory approval in Mexico and Thailand.
Have you checked on the country's respective medical ndevice website ?
 

sreenu927

Quite Involved in Discussions
#5
Hi Danush,

Welcome to Cove!

For Thai regulations, you can see the attachment provided by Joanne.

Thanks Joanne, for sharing the specific requirements list!

Attached are a few documents for understanding Mexican regulations, also attached is the latest documentation requirements for registering medical devices.

I hope this helps.

Regards,
Sreenu
 

Attachments

bio_subbu

Forum Moderator
Moderator
#7
Will appreciate any information about medical device regulations in Thailand. Our company developed a silicone implant for long-term use and is intrested in receiving regulatory approval in Mexico and Thailand.
Hi,

As regards to Thailand Medical Devices Regulation, the Medical Device Act 2008 has been started and effective since 6 March 2008. However, the regulation has the transition period for issuing more sub regulation. All ordinances or notifications which have not been revised they are still effective according to the previous act<1998>.

The “Medical Device Control Division, Food & Drug Administration of Thailand Ministry of Public Health”, is now in the process of drafting sub-regulations which will be included the new items of device in the classification by the risk based consideration. Apart from that, the manufacturer or importer needs to get their establishment license. Contrary to this requirement, you may want to find and appoint a local distributor before the product registration process. The establishment license will be easier if your representative already submitted the application for medical device establishment license.

The product approval process is according to the current regulation which can be followed the previous Act 1998, medical devices EXCEPT syringe, HIV test kit, condom, gloves, contact lens, physical medicine, alcohol detection and breast implant or enhancer are classified as the general medical devices which are not strictly control.

The “Certificate of Free Sale” (CFS) together with the catalog of products must be submitted for the verification by the Thai Food and Drug Administration.

The CFS must be issued by the government authority of the country origin and must be included the manufacturer information (names and address), Product information such as trade name and model or catalog number and etc...

After the verification process, they will provide a document for the importation process at the Custom Office.

For more details please refer “Medical device Act, BE.2551 (2008)” and document on “Importing of General Medical Devices (10 August 2010)

Regards
S. Subramaniam
 

Attachments

D

danush

Guest
#10
does somebody know if a quality system audit is required by the local authorities or ISO 13485 is sufficient?
 

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