In-Hospital Use of Orphaned, Obsolete and Discontinued Devices Under Circular 2/2018

1. Key takeaways

Malaysia recognises three categories of device that fall outside the normal supply chain: orphaned, obsolete and discontinued devices. The definitions come from MDA Circular No. 2/2018 (Rev. 2, 30 December 2019). An orphaned device is one whose manufacturer or authorised representative has ceased operations while the device remains in use in a hospital. An obsolete device is one that has become obsolete or is no longer produced because of technological evolution. A discontinued device is one that is no longer distributed.

For devices in these categories that have already been placed on the market, the policy grants an administrative exemption from registration and EL requirements. The exemption is narrow in a way that is easy to miss: it covers stock already in use, and it comes with an obligation on the healthcare facility to identify the device and submit a notification or listing to the MDA.

• Legal source: MDA Circular No. 2/2018 (Rev. 2, 30 December 2019).
• Orphaned: manufacturer or AR has ceased operations; the device is already in hospital use.
• Obsolete: obsolete, or no longer produced because of technological evolution.
• Discontinued: no longer distributed.
• Exemption: administrative exemption from registration and EL requirements for devices already placed on the market.
• Facility duty: the healthcare facility must identify the device and submit a notification or listing to the MDA.
• Risk allocation: the risk of use is borne by the establishment, the user and the healthcare facility.
• Residual duty: the establishment remains responsible for post-market issues of obsolete and discontinued devices at least for the service life determined by the manufacturer.

2. Legal basis

The Circular is best understood as a stock governance instrument. It addresses a real problem: devices that remain clinically useful after the commercial relationship behind them has ended. Forcing those devices through a registration process designed for active products would remove them from service, which is not in anyone’s interest. The Circular therefore relieves the administrative burden for existing stock while keeping the safety obligations intact. What it does not do is create a route by which new product can be placed on the market without registration.

The obligations that survive the exemption are the ones that matter. The establishment remains responsible for post-market issues at least for the service life determined by the manufacturer, and it must continue to observe the registration conditions and the Medical Device (Duties and Obligations of Establishments) Regulations 2019. The user duty in section 43 of Act 737 completes the picture: a user must ensure that a device used for others is safe and effective, is used for its intended purpose, is used in accordance with the manufacturer’s instructions, and is correctly installed, tested, commissioned and maintained.

3. Expert insights

Insight 1: the exemption attaches to stock, not to a product line.

The distinction between stock already in a hospital and product that could still be supplied is the hinge of the whole policy. The Circular is explicit that an unregistered obsolete or discontinued device which is intended to be placed on the market still requires a valid registration certificate. The exemption covers the inventory that is already in service; it does not cover a new placement, however old the design may be. Companies that read the Circular as a general permission for legacy products expose themselves to the section 5 prohibition.

Insight 2: the exemption moves the work, it does not remove it.

Registration and licensing are replaced by identification and notification. The healthcare facility has to know what it holds and has to tell the MDA. That shift matters because the facility, not the manufacturer, is the party with the physical inventory and the clinical records. Where the manufacturer has ceased operations, the facility may be the only party that can describe what is in use. A hospital that has never inventoried these devices cannot make the notification, and the exemption is not available in practice until it can.

Insight 3: risk allocation is explicit, and it is not a formality.

The Circular places the risk of use on the establishment, the user and the healthcare facility. The provision is significant because it forecloses the assumption that an exempt device is an unregulated device. Clinical decisions about continued use, maintenance arrangements and the availability of spare parts remain live questions for the parties holding the device, and those questions are asked in exactly the circumstances where an incident has occurred.

Insight 4: the residual post-market duty runs to the service life.

For obsolete and discontinued devices, the establishment remains responsible for post-market issues at least for the service life determined by the manufacturer. That phrase defines the horizon of the obligation, and it is set by a document the manufacturer produced, not by the date on which distribution stopped. A company planning an exit therefore needs to know what service life it has declared, because that declaration fixes how long its obligations continue after the last shipment.

Insight 5: section 43 puts the user in the compliance chain.

The user duty requires safety and effectiveness, use for the intended purpose, use in accordance with the manufacturer’s instructions, and correct installation, testing, commissioning and maintenance. For devices covered by the Circular, these duties fall on parties who may have no relationship with the original manufacturer. That is precisely why the exempt categories need documentation: without it, a hospital cannot demonstrate that installation and maintenance were correct, and the user duty becomes impossible to discharge.

Insight 6: for an authorised representative, exit is a project, not a notice.

Where a company acts as AR for a brand and intends to leave the market, the discontinuation arrangement has to be designed together with distribution records, PMS obligations and customer notification. The Circular supplies a framework for governing existing stock; it is not a framework for exemption from the consequences of leaving. The three practical deliverables are a customer notification letter covering stock in the field, a defined period for spare parts and service, and a plan for who carries the post-market obligations once the AR role ends.

4. Practical recommendations

• Inventory the three categories before relying on the exemption. A facility-level list is the precondition for the notification to the MDA.
• Separate stock in use from stock for supply. Any unregistered obsolete or discontinued unit intended for the market needs a registration certificate.
• Record the declared service life. The post-market duty runs at least to that horizon, so the number needs to be known and documented.
• Keep installation, testing, commissioning and maintenance records. They are the evidence for the section 43 duty.
• Plan exits in three parts. Customer notification for existing stock, a spare parts and service commitment period, and a succession plan for post-market obligations.
• Reconcile the exit plan with distribution records. The records define who holds what, and therefore who must be notified.
• Check the updated policy. MDA Circular No. 2/2022 revises the comparable framework, so both instruments should be read together.

5. Verification checklist

• □ MDA Circular Letter No. 2/2018 (Revision 2), 30 December 2019, on file
• □ MDA Circular No. 2/2022 reviewed as the updated version of the comparable policy
• □ Act 737 section 43 confirmed
• □ Three category definitions applied consistently across the inventory
• □ Notification or listing submitted to the MDA for devices in use
• □ Manufacturer-declared service life recorded for obsolete and discontinued devices
• □ Exit plan covers customer notification, service commitment and obligation succession

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including Malaysia. Our team prepares dossiers to ASEAN CSDT structure, manages submissions and deficiency responses with the MDA, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com