Certified true copy of Manufacturer
Licence or Permit issued by the Government or Health Authority of the
country of origin to certify that the manufacturer is a legitimate manufacturer
in the manufacture of the Goods being offered.
If Manufacturer Licence or Permit is not
necessary in that country of origin, Manufacturers shall declare explicitly in
the tender and submit a certified true copy of Manufacturer’s statement to
support.
For Manufacturer originated in China, the
required Manufacturer Licence or Permit is referred to “Medical Device
Manufacturing Enterprise License” (in Chinese:醫療器械生產企業許可証) which is specified in
Regulations for the Supervision and Administration of Medical Devices, State
Food and Drug Administration, China. |