Góc nhìn & tin tức xuất khẩu
Tin chính sách BPOM Indonesia, DAV Việt Nam; góc nhìn thị trường ASEAN; nghiên cứu tình huống xuất khẩu tiêu biểu. Cập nhật hằng tuần.
Chinese Pharma Equipment to ASEAN: The Complete Import & GMP Compliance Guide
Pharma machinery is a capital good — drug registration does not apply. Four steps across six ASEAN markets: HS classification and ACFTA/RCEP zero-duty customs, equipment GMP documentation and FAT, on-site IQ/OQ/PQ qualification, and per-country statutory certs.
Cert guide: ISO 13485 vs GMP design — which one should pharma equipment makers do first?
For pharma equipment makers, GMP-oriented design and qualification documentation (URS/DQ/FAT/IQ/OQ/PQ) is the baseline buyers' facility inspections rest on; ISO 13485 is a medical-device QMS. What each covers and which to pursue first.
Chinese Pharma Equipment to ASEAN: The Complete Import & GMP Compliance Guide
Pharma machinery is a capital good — drug registration does not apply. Four steps across six ASEAN markets: HS classification and ACFTA/RCEP zero-duty customs, equipment GMP documentation and FAT, on-site IQ/OQ/PQ qualification, and per-country statutory certs.
Cert guide: ISO 13485 vs GMP design — which one should pharma equipment makers do first?
For pharma equipment makers, GMP-oriented design and qualification documentation (URS/DQ/FAT/IQ/OQ/PQ) is the baseline buyers' facility inspections rest on; ISO 13485 is a medical-device QMS. What each covers and which to pursue first.