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Territory Southeast Asia  Official Language Indonesian/English  Regulatory Authority Name Badan Pengawas Obat dan Makanan (BPOM)  Regulatory Authority Website https://www.pom.go.id/   Mail ID halobpom@pom.go.id  Regulation Name Government Regulation No. 74 of 1996 on Pharmaceutical Affairs  Local Authorized Representative Yes  Classification of Medical Devices New Drug, Generic Drug, Biologic, Biosimilar.  Registration Timeline 3 to 12 months  Li...

MoH Ministry of Health of Argentina MoH Website https://www.argentina.gob.ar/salud Regulatory Authority The National Administration of Drugs, Food and Medical Technology Link for Regulatory Authority https://www.argentina.gob.ar/anmat Applicable Regulation DECREE NO. 150/1992 ESTABLISHES THE RULES FOR THE REGISTRATION, PREPARATION, DIVISION, PRESCRIPTION, SALE, MARKETING, EXPORT AND IMPORT OF MEDICINES. Biologics/Drugs/Pharmaceutical/Medicine/OTC- General Registration Procedure and Requirement i...

MoH: Armenia Ministry of Health MoH website: https://www.gov.am/en/structure/1/ Regulatory Authority: Scientific centre of drug and medical technology expertise Link for Regulatory Authority: https://www.pharm.am/index.php/en/ Overview The registration of medicinal products in the Republic of Armenia involves adherence to a set of stringent requirements outlined in various legislative acts. The fundamental legal framework comprises the Laws of the Republic of Armenia, specifi...

“Professional use” Test Kit – Procedure for registration in UK  Novel Corona Virus Disease 2019 (COVID-19) is a different variety of disease that has never been seen in humans before, impacting being a pandemic, and affecting the world since the year 2020. One of the most difficult aspects of coronavirus is the ambiguity of not knowing who has been infected or whether it is safe to resume normal activities. Testing of high quality might assist provide assurance. However, no good thing...