Obsolete and discontinued devices: keeping hospital equipment in service legally.
Infusion pumps, monitors and imaging systems often outlive their registration. When the manufacturer stops making or supplying a device, its registration can no longer be maintained. MDA/GD/0071 is the route that keeps the installed devices working, with an Exemption Letter.
Short answer: a previously registered device that is now obsolete or discontinued can stay in use in Malaysian hospitals, clinics and wellness centres if MDA confirms its status. The manufacturer or authorised representative applies under MDA/GD/0071 (RM300, decided in 10 working days). MDA’s Exemption Letter lasts 3 years and allows import and export only for maintenance and repair.
The route at a glance
| Item | Rule (MDA/GD/0071) |
|---|---|
| Legal basis | Medical Device (Exemption) Order 2024, subparagraph 3(2)(b): exempt from registration under section 5 once declared obsolete or discontinued by the manufacturer and confirmed by MDA |
| Which devices | Previously registered, no longer eligible for registration, still in use and well maintained in a healthcare facility, wellness centre or related facility |
| Who applies | The person responsible at the manufacturer or authorised representative |
| How | MDA’s online form (a Google account is needed), one application per registration |
| Charge | RM300 per application, non-refundable; invoice on BayarNow in 1–7 working days, payable within 3 working days |
| Decision | 10 working days from a complete application with cleared payment |
| Exemption Letter | Valid 3 years, no extension; then a new application |
| After confirmation | No import or distribution on the market; import and export for maintenance or repair only; post-market duties for at least 5 years |
Obsolete or discontinued: which one applies
| Obsolete | Discontinued | |
|---|---|---|
| Meaning | Outdated and no longer manufactured, because of design changes or new technology | No longer in distribution |
| Why registration cannot continue | The legal manufacturer declared it obsolete and the technical documents for registration are no longer available, or production of its accessories has stopped | The legal manufacturer or AR has stopped distributing it in Malaysia |
| Common to both | Registered with MDA before; still in use at the facility, working and properly maintained | |
Typical cases are hospital equipment whose maker launched a successor model, devices whose Malaysian AR stopped carrying the brand, and systems that still work but whose manufacturer can no longer supply an updated essential principles checklist or CSDT for re-registration. A registration that simply lapsed is not covered: the route is for devices that can no longer be registered, not for missed renewals.
The documents
- Applicant and device details: the establishment, its licence number and role, the device’s previous registration number and last validity period, and the date the manufacturer declared it obsolete or discontinued.
- Device condition and usage: for each healthcare facility, whether the device is in use and a confirmation of its safety and performance (Appendix 1).
- A certificate and report confirming the device’s safety and performance for its intended use.
- The manufacturer’s declaration letter (Annex C), on its letterhead, signed and stamped, stating the device and the date of obsolescence or discontinuation.
- The healthcare facility’s declaration letter (Annex D), agreeing to keep using the device.
- A transition plan: the estimated timeline for continued maintenance support.
- The attestation and declaration form (Annex E), signed and stamped.
Every document must be uploaded at submission, and every declaration signed and stamped.
What the establishment owes afterwards
- Technical assistance and maintenance support for the facility, as it needs.
- All post-market duties under the Medical Device (Duties and Obligations of Establishments) Regulations 2019 for at least 5 years from the date of confirmation: mandatory problem reporting, field corrective actions and recalls.
- Distribution, complaint, problem-report, field-corrective-action and recall records kept for 5 years from the end of support, and handed to MDA on request.
- Import and export of the device or its accessories only for maintenance or repair, under the valid Exemption Letter.
MDA can still order users to stop using a device it finds unsafe or ineffective. Running these duties for a shrinking installed base is often the part suppliers underestimate; our post-market surveillance retainer covers it.
Related routes
- Orphaned devices (manufacturer or AR no longer operating) are a separate exemption; Circular Letter No. 2/2022 covers orphaned, obsolete and discontinued devices together, and MDA/GD/0071 now sets the application for the last two. See the exemptions guide.
- Refurbished devices placed back on the market follow a different regime: refurbished medical devices.
- A new model replacing the old one needs its own MDA registration.
Bagaimana peranti perubatan usang atau dihentikan boleh terus digunakan di hospital?
Peranti yang pernah didaftarkan tetapi kini usang (obsolete) atau dihentikan (discontinued) boleh terus digunakan di hospital, klinik dan pusat kesihatan jika MDA mengesahkan statusnya. Pengilang atau wakil sah memohon di bawah MDA/GD/0071: caj RM300, keputusan dalam 10 hari bekerja. Surat Pengecualian sah 3 tahun tanpa lanjutan, dan peranti hanya boleh diimport atau dieksport untuk penyelenggaraan atau pembaikan. WhatsApp 010-206 2070.
Frequently asked questions
What is an obsolete medical device under MDA rules?
What is a discontinued medical device?
Who applies, the hospital or the supplier?
How much does it cost and how long does it take?
How long does the Exemption Letter last?
Can we still import spare parts?
What does the establishment owe after confirmation?
What about orphaned devices whose manufacturer no longer exists?
Supplying hospitals with equipment at end of life?
Tell us which devices are obsolete or discontinued and where they are installed. We will confirm eligibility, prepare the MDA/GD/0071 application and run the post-market duties that follow.