UK, As the clock, strikes midnight on 31st January 2020.
The UK would have officially left the European Union and enter a transition period till 31st December 2020.
During this
read more...Regulatory News
Indonesia, Exemption from Import Duties for Health Services Goods
The importation of health goods in Indonesia are normally subjected to a fiscal levy through customs duties and taxes in the framework of import (PDRI).
The importation of items are divided
read more...USA, Online Submissions of Orphan Designation Requests to be allowed by FDA.
USA, Online Submissions of Orphan Designation Requests to be allowed by FDA.
Upcoming in the later part of 2020, we will see them move from a paper-based process to a new
read more...Looking at importing into The Philippines
Importing into the Philippines is pretty a straight forward process.
Provided the guidelines provided by the Bureau of Customs are adhered to.
Goods entering the Philippines’ territories are either regulated, restricted or
read more...Vietnam MOH amend regulations for effective period of the import license and date of CSDT
Vietnam, Ministry of Health (Department of Medical Equipment and Construction) had a Business Dialogue Conference in regard to amended regulations on the management of medical equipment.
Here are some highlights on
read more...Malaysia, Medical Devices advertising
As of Medical Device (Advertising) Regulations, no advertisement of any registered medical device can be done without the approval from the Ministry of Health Malaysia.
In order to make an advertisement
read more...World Health Organization first bio-similar pre-qualification
WHO (World Health Organization), pre qualified their first bio-similar.
This newly pre qualified medicine is Samsung Bioepis’ Ontruzant which is a bio-similar version of trastuzumab.
After assessment WHO stated that
read more...2019 Round-up & What’s upcoming in 2020
As we close the year of 2019, let’s look at the most interesting stories of the past year and look forward to what’s installed in the start of the new
read more...World Health Organisation Latest Guideline on Data Integrity
World Health Organization (WHO) drafted a new guideline on data integrity on 19th November 2019. This highlighted the importance of the reliability of data and information in the production and
read more...