Fillable Printable Template of Letter of Authorisation

Template of Letter of Authorisation

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

[Date]

Dear Sir/Madam,

Subject: Letter of Authorisation for [name of Registrant]

We, [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.

Yours Sincerely,

[Signature]

[Full Name and Title of Senior Company Official]

[Company stamp]