Marketing History Declaration Template and Safety Declaration Template
Marketing History Declaration Template and Safety Declaration Template
Marketing History Declaration Template and Safety Declaration Template
[Date]
Dear Sir/Madam,
Yours Sincerely,
[Signature]
[Full Name and Title of Senior Company Official]
[Company stamp]
ภาคผนวก ๓
Safety Declaration Template
[Date]
Dear Sir/Madam,
Yours Sincerely,
[Signature]
[Full Name and Title of Senior Company Official]
[Company stamp]
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1
Serious deterioration in the state of health, in relation to a person
means: (a) a life-threatening illness or injury suffered by that person;
(b) a permanent impairment of a bodily function of that person; (c)
any permanent damage to any part of that person’s body; or (d) a
condition requiring medical or surgical intervention to prevent any
such permanent impairment or damage.
ภาคผนวก ๔
Declaration Letter
[Date]
Dear Sir/Madam,
Yours Sincerely,
[Signature]
[Full Name and Title of Senior Company Official]
[Company stamp]
Declaration Letter (ภาคผนวก ๒-๔)
[Date]
Dear Sir/Madam,
hereby declare that the medical devices have been marketed in at least
the two independent reference regulatory agencies’ jurisdictions for at
least one year as showing below;
1. (reference regulatory agencies) : The first dates of market introduction in
[jurisdiction/country] and [jurisdiction/country] were [mm/yyyy] and
[mm/yyyy]
2. (reference regulatory agencies) : The first dates of market introduction in
[jurisdiction/country] and [jurisdiction/country] were [mm/yyyy] and
[mm/yyyy]
3. ...
Yours Sincerely,
[Signature]
[Full Name and Title of Senior Company Official]
[Company stamp]
----------------------------------------------------------------------------------------------------------
---------------------------------
1
Serious deterioration in the state of health, in relation to a person means:
(a) a life-threatening illness or injury suffered by that person; (b) a
permanent impairment of a bodily function of that person; (c) any
permanent damage to any part of that person’s body; or (d) a condition
requiring medical or surgical intervention to prevent any such permanent
impairment or damage.