Thailand Breast Implant Regulation: B.E. 2562

Breast Implant regulation: B.E. 2562

Main content revision from regulation B.E. 2540

Signed date: 7 November 2019

Announced date: 18 December 2019

Effective date: 5 May 2020

There’s a change in up-classification of the breast implant from “Notification class” to “Registration class” which means the highest class. The main changes from previous regulation are:

· Breast implant must be sold to only the hospitals/clinics or certified healthcare professionals only. If sold to distributors, the distributors must obtain “medical device seller license”

· Breast implant must comply to ISO 14607:2018 or equivalent standards.

· Importer must keep patient registry at least 10 years which record must include

o Name of hospitals/clinics

o Name of physician with license number

o Breast implant name and model

o Lot no.

o Serial no.

o Product license no.

o Manufacturer name and address

o Importer name and address

o Distributor name and address

o Patient info or patient hospital ID that can link to know the patient

o Date of implant

· Thai Label, additional from previous requirement:

o Width, height and volume of breast implant (if use symbol can explain the symbol in Thai package insert)

o Year of expiry date must show in 4 digits

o Serial number

o For textured type only, add the statement “Usage of Silicone Breast Implant Textured type has a risk of Breast implant associated anaplastic large cell lymphoma (BIA - ALCL)” in “red” font

· Thai package insert, in conformance with original package insert

· For products already got registration before this regulation, allow for use the old label for 180 days after this announcement.

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