Medsafe

E901095

Medsafe is New Zealand’s national medicines and medical devices safety authority responsible for regulating and monitoring their quality, safety, and efficacy.

All labels observed (1)

Label Occurrences
Medsafe canonical 1

How this entity was disambiguated

Statements (48)

Predicate Object
instanceOf medical device regulatory authority
medicines regulatory authority
collaboratesWith Australia Therapeutic Goods Administration
World Health Organization
other international regulatory agencies
country New Zealand
hasOffice Auckland
Wellington
jurisdiction New Zealand
language English
legalBasis Medicines Act 1981
Medicines Regulations 1984
related New Zealand health legislation
operatedBy New Zealand Ministry of Health
parentOrganization New Zealand Ministry of Health
publishes guidelines for sponsors
medicine safety communications
prescriber updates
responsibility advising the Minister of Health on medical device safety
advising the Minister of Health on medicine safety
benefit–risk assessment of medicines
classification of medicines
enforcement of medical devices legislation
enforcement of medicines legislation
ensuring efficacy of medicines
ensuring quality of medical devices
ensuring quality of medicines
licensing of medicines
maintaining product registers
monitoring medical device safety
monitoring medicine safety
pharmacovigilance
post‑market surveillance of medical devices
post‑market surveillance of medicines
pre‑market approval of medicines
publishing consumer medicine information
publishing medicine data sheets
publishing safety alerts
regulation of medical devices
regulation of medicines
scope clinical trials oversight (medicines)
human medicines
medical devices
targetAudience general public
healthcare professionals
medical device sponsors
medicine sponsors
website https://www.medsafe.govt.nz

How these facts were elicited

Referenced by (1)

Full triples — surface form annotated when it differs from this entity's canonical label.