Singapore legislation
Regulation 3D
Regulation 3D
Manufacture of specified dental medical devices
Subregulation 1
Subject to paragraphs (3) and (4), a person may manufacture a specified dental medical device without holding a manufacturer’s licence under section 12(1) of the Act if —
the person does not manufacture any medical device that is not a specified dental medical device; and
the person has given prior notice of the manufacture of the specified dental medical device to the Authority in accordance with paragraph (2).
Subregulation 2
The notice mentioned in paragraph (1)(b) must —
be in the form and manner specified on the Authority’s website; and
be accompanied by all of the following information in writing:
the particulars of the person giving the notice as required by the Authority;
the premises where the manufacture is to be carried out;
a statement of the manufacture involved, including the scope of the manufacturing operations and processes;
the types of specified dental medical devices manufactured or intended to be manufactured by the person.
Subregulation 3
To avoid doubt, a person mentioned in paragraph (1) must give notice to the Authority in accordance with paragraph (2) each time the person intends to manufacture a type of specified dental medical device that has not previously been mentioned in the information provided by the person in an earlier notice given under paragraph (1)(b).
Subregulation 4
A person mentioned in paragraph (1) is subject to the duties and obligations of a manufacturer of a medical device under regulations 33(a), 38, 39, 41, 42, 44, 45, 46 and 47.
Subregulation 5
This regulation does not apply to the manufacture of specified dental medical devices in accordance with regulation 3(1A) by a specified healthcare service licensee.
Subregulation 6
In this regulation —
Definition
“dental medical device” means any medical device that is intended by its manufacturer to be used on a patient by a registered dentist in the course of providing dental treatment to the patient;
Definition
“specified dental medical device” means a dental medical device that —
is a custom-made medical device; and
would be assigned to Class A or Class B according to regulation 24 if the dental medical device is registered.