Letter Of Authorisation Template


Letter of Authorisation Template
[To be printed on Company Letterhead of Product Owner]
Medical Device Branch
Therapeutic Products Division
Health Products Regulation Group
Health Sciences Authority
Dear Sir/Madam,
Subject: Letter of Authorisation for
[name of Registrant]
[name of Product
Owner], as the Product Owner, hereby authorise
[name of
Registrant], as the Registrant to prepare and submit applications for the
evaluation and registration of medical devices to the Health Sciences Authority
on our behalf.
This authorisation shall apply to the following medical devices:
[List containing product names of medical devices]
We also authorise
[name of Registrant]
to make declarations and to submit
documents on our behalf, regarding the above medical devices, in support of this
application. These declarations and submissions are made pursuant to the
requirements of the Health Products Act, the Health Products (Medical Devices)
Regulations and any other applicable laws that may also be in force.
This authorisation shall remain in effect until our notification to the Health
Sciences Authority in writing (either by postal mail or facsimile transmission) that
the authorisation is revoked.
We undertake to provide post-market support and assistance to the Registrant as
may be required in relation to any matter involving the above medical devices.
We acknowledge that any non-compliance with any registration condition issued
by the Health Sciences Authority in relation to medical devices registered on the
Singapore Medical Device Register may result in the suspension or cancellation
of the medical device registration.
We agree to assist the Health Sciences Authority with any request for information
on the above medical devices.


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