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.