Statute Details
- Title: Health Products (Supply of Medical Devices — Exemption) Order 2022
- Act Code: HPA2007-S688-2022
- Legislative Type: Subsidiary Legislation (SL)
- Authorising Act: Health Products Act 2007
- Enacting Authority: Health Sciences Authority (HSA)
- Order Number: S 688/2022
- Commencement: 1 September 2022
- Date Made: 12 August 2022
- Status (as provided): Current version as at 27 Mar 2026
- Key Provisions: Section 1 (citation and commencement); Section 2 (retail supply exemption); Section 3 (revocation)
What Is This Legislation About?
The Health Products (Supply of Medical Devices — Exemption) Order 2022 (“the Order”) is a targeted regulatory instrument made under the Health Products Act 2007. In plain terms, it creates a narrow exemption from a specific statutory requirement relating to the supply of medical devices by retail.
The Order addresses a practical compliance issue: certain categories of medical devices that were imported before the Order’s commencement date are treated differently for retail supply purposes. This means that, for those devices, the usual rule in section 15(1) of the Health Products Act 2007 does not apply when they are supplied by retail by a person.
Although the Order is short, it is legally significant because it (i) identifies the exact device categories covered, (ii) ties the exemption to an import timing condition (“imported before 1 September 2022”), and (iii) revokes an earlier exemption order from 2020. For practitioners, the key is understanding how the exemption interacts with the baseline medical device supply regime under the Health Products Act 2007.
What Are the Key Provisions?
1. Citation and commencement (Section 1)
Section 1 provides the formal name of the instrument and states that it comes into operation on 1 September 2022. This commencement date is crucial because the exemption in section 2 is expressly limited to medical devices imported before that date. In other words, the legal effect of the Order depends on whether the relevant devices were imported before 1 September 2022.
2. Exemption in relation to supply by retail (Section 2)
Section 2 is the core operative provision. It states that section 15(1) of the Health Products Act 2007 does not apply to the supply by retail by a person of any of the following medical devices, imported before 1 September 2022:
- (a) a particulate respirator
- (b) any protective gear
- (c) a surgical mask
- (d) a thermometer for measuring human body temperature
Practical meaning: For the listed device categories, and only where the devices were imported before the commencement date, the retail supplier is exempt from the requirement contained in section 15(1) of the Act. The Order does not redefine the devices; it relies on the ordinary meaning of the categories as used in the medical device context. For compliance work, lawyers and regulated entities typically need to map these categories to product specifications, labelling, intended use, and regulatory classification.
Timing condition: The exemption is not “for all time” and not “for all devices.” It is anchored to the import date. This creates evidentiary and documentation issues: import records, bills of lading, customs declarations, invoices, and supplier statements may become central to demonstrating that the devices were imported before 1 September 2022.
Retail supply limitation: The exemption is expressly limited to “supply by retail”. This phrase matters because wholesale, distribution, or other forms of supply may not fall within the exemption. Practitioners should therefore consider the business model—whether the entity sells directly to end-users (retail) or supplies to other businesses (wholesale/distribution). The Order’s legal effect is confined to retail supply by a person.
3. Revocation of the 2020 exemption order (Section 3)
Section 3 revokes the earlier instrument: Health Products (Import, Wholesale and Supply of Medical Devices — Exemption) Order 2020 (G.N. No. S 78/2020).
This revocation has two implications. First, it signals that the regulatory landscape has moved on from the earlier exemption framework. Second, it means that any reliance on the 2020 order for ongoing compliance must be reassessed. If a party previously relied on the 2020 exemption, the question becomes whether the 2022 Order now governs the relevant devices and activities, or whether the revocation removes the legal basis for continued exemption.
Because the 2022 Order is narrower in its operative scope (it focuses on retail supply and specifies the device categories), revocation may affect parties that previously benefitted from broader exemptions under the 2020 instrument. Practitioners should therefore review both the 2020 and 2022 orders in tandem when advising on legacy stock, transitional arrangements, and compliance risk.
How Is This Legislation Structured?
The Order is structured as a short, three-section subsidiary legislation instrument:
- Section 1 (Citation and commencement): identifies the Order and sets the effective date.
- Section 2 (Exemption in relation to supply by retail): provides the substantive exemption, specifying (i) the legal provision from the Health Products Act 2007 that is disapplied, (ii) the activity (supply by retail), (iii) the covered device categories, and (iv) the import timing condition.
- Section 3 (Revocation): removes the earlier 2020 exemption order.
From a legal drafting perspective, the Order is an example of a “disapplication” mechanism: it does not create a new regulatory regime from scratch. Instead, it temporarily or conditionally removes the application of an existing statutory requirement for a defined class of products and a defined type of supply activity.
Who Does This Legislation Apply To?
The Order applies to “a person” who supplies the specified medical devices by retail. In practice, this typically includes retailers and businesses that sell medical devices directly to consumers or end-users. The legal effect is not limited to manufacturers or importers; it is directed at the act of retail supply.
The exemption is also conditional on the devices being imported before 1 September 2022. Therefore, the Order’s applicability depends on both the type of supplier activity (retail supply) and the historical import timing of the specific products in question. Entities that cannot substantiate the import date may be unable to rely on the exemption.
Why Is This Legislation Important?
Although the Order is brief, it can materially affect compliance obligations for businesses dealing with medical devices in the retail channel. The disapplication of section 15(1) of the Health Products Act 2007 means that, for the covered devices and conditions, retailers may not need to comply with the specific requirement that would otherwise apply. This can reduce regulatory friction for legacy stock and transitional supply chains.
From a risk management perspective, the Order introduces a classic compliance fault line: product category and import date. Even where a retailer sells one of the listed device types (e.g., surgical masks), the exemption may not be available if the devices were imported on or after 1 September 2022. Conversely, even if devices were imported before that date, the exemption may not apply if the supply activity is not “by retail” or if the product does not fall within the listed categories (for example, borderline items that may be argued to be “protective gear” or not).
Finally, the revocation of the 2020 exemption order underscores that exemptions are time- and instrument-specific. Practitioners advising on inventory held across regulatory transitions should not assume continuity. Instead, they should confirm which exemption instrument applies, for which device categories, for which supply channel, and for which relevant dates.
Related Legislation
- Health Products Act 2007 (including section 70 (power to make orders) and section 15(1) (baseline requirement disapplied by this Order))
- Health Products (Import, Wholesale and Supply of Medical Devices — Exemption) Order 2020 (G.N. No. S 78/2020) — revoked by section 3 of this Order
Source Documents
This article provides an overview of the Health Products (Supply of Medical Devices — Exemption) Order 2022 for legal research and educational purposes. It does not constitute legal advice. Readers should consult the official text for authoritative provisions.