Regulation 6
Exception for custom-made medical devices, etc.
of Health Products (Medical Devices) Regulations 2010
Subsidiary LegislationIn forceProvision 27 of 81
Regulation 6
Amended byS 318/2018 wef 01/06/2018
Despite any other provision in this Division, the prohibition in section 15(1) of the Act against the supply of an unregistered health product does not apply to the supply of —
(a)
a medical device that is manufactured in accordance with regulation 3;
(b)
a laboratory‑developed test that is an unregistered medical device and is manufactured in accordance with regulation 3B; or
(c)
a custom‑made medical device that is an unregistered medical device.