GN-27 - Authorisation Route for Supply on Request of PHMC-Licensed Facility

Purpose	To seek exemption from prodct registration for the import and supply of an  unregistered medical device to a clinical laboratory, medical clinic or private  hospital licensed under the PHMC Act (Cap. 248)
Licence	Only licensed importer will be allowed to import the unregistered medical device
Application Procedure	Refer to GN-27: Application Form for Exemption from Product Registration for  the Import of an Unregistered Medical Device for Supply to Clinical Laboratory,  Medical Clinic or Private Hospital licensed under the PHMC Act.
Application Submitter	Licensed importer
Documentary Requirements	Refer to GN-27: Guidance on the Requirements for Exemption from Product  Registration for the Import of an Unregistered Medical Device for Supply to  Clinical Laboratory, Medical Clinic or Private Hospital licensed under the PHMC Act. *Attestation by authorised person (i.e. chief executive/ head of department) from facility is required. Documents include:- Intended purpose, as stated in Instructions for Use, Product Insert, or Operations Manual by   the product owner (documentary evidence to be provided), A copy of the primary medical device label, A copy of the Clinical Laboratory's, Medical Clinic's or Private Hospital's licence under the Private Hospital and Medical Clinics (PHMC) Act (Cap. 248), with the PHMC Licence Number clearly legible.
Validity period of Authorisation	12 months from date of approval