Ministry of Public Health announced the Amendment of the Application Form for Registration of Establishment Import License 2019 (No.3) and Registration of Establishment Manufacturing License 2019 (No.3). By virtue of Clause 1 of the ministerial regulations specifying rules, procedures and conditions for registration of Establishment Manufacturing License which was issued by virtue in section 5 and Section 15, paragraph two of the Medical Device Act 2008. Secretary-General of the Food and Drug Administration with the approval of the Medical Device Board issued the announcement as follows:

1. Amendment of Establishment Import License Application Form and Establishment Manufacturing License Application Form. 

2. An application for registration of Establishment Import License and Establishment Manufacturing License submitted before the enforcement date shall be evaluated accordingly to this announcement. Therefore, reviewer may require additional evidence as appropriate.                                                                          

3. This announcement shall come into force from 12 February, 2020.

References:

1. Ministry of Public Health Announcement regarding Amendment of the Application Form in accordance with the Ministerial Regulations, Specify the Rules, Procedures and Conditions for Registration of Establishment Import License 2019 (No.3)
2. Ministry of Public Health Announcement regarding Amendment of the Application Form in accordance with the Ministerial Regulations, Specify the Rules, Procedures and Conditions for Registration of Establishment Manufacturing License 2019 (No.3)