Document ID: chunk:federal_register_of_legislation:F2025C00024:clause:3_4:p3
Version: federal_register_of_legislation:F2025C00024
Segment Type: clause
Provision Reference: sch 3 cl 4 (pt 3/3)
Character Range: 9672–11434

does not include a MDSAP certificate.
recognised auditing organisation means an organisation authorised to perform audits under the Medical Device Single Audit Program by the Regulatory Authority Council, in relation to that program, comprising the Australian Therapeutic Goods Administration, the United States Food and Drug Administration, the Brazilian Agência Nacional de Vigilância Sanitária, Health Canada, and Japan's Ministry of Health, Labour and Welfare and the Japanese Pharmaceuticals and Medical Devices Agency.
Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.
relevant implantable medical device means an implantable medical device other than a medical device:
 (a) mentioned in paragraphs 13A.1(1)(b) or (ba) of Schedule 1 to the Regulations; or
 (b) to which subclause 13A.1(2) of Schedule 1 to the Regulations applies.
Note: Medical devices mentioned in paragraph 13A.1(1)(b) of Schedule 1 to the Regulations include, for example, sutures, staples, dental fillings and dental braces. The medical devices mentioned in paragraph 13A.1(1)(ba) of Schedule 1 to the Regulations are medical devices that are intended by the manufacturer to be for export only.
Singapore Health Products Act means the Health Products Act 2007 of Singapore as in force on 1 July 2022.
Singapore Register of Health Products means the Register of Health Products kept and maintained by the Health Sciences Authority of Singapore under section 34 of the Singapore Health Products Act.
Therapeutic Goods Administration means that part of the Department known as the Therapeutic Goods Administration.
US FDC Act means the Federal Food, Drug, and Cosmetic Act of the United States, as in force immediately before the commencement of this instrument.