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 …
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 …
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 …
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 …
Malaysia, Medical Devices advertising
As of Medical Device (Advertising) Regulations, no advertisement of any registered medical device can be done without the approval from …
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 …
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 …
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 …
Philippines FDA has been officially listed ASEAN MRA for GMP
Philippines FDA has been officially listed under the ASEAN Mutual Recognition Arrangement(MRA) on Good Manufacturing Practices(GMP) for medicinal products. This …