Penalties for unregistered medical devices in Malaysia.
Up to RM200,000, up to 3 years in prison, or both. The Medical Device Act 2012 also reaches directors and managers personally, and MDA can seize the stock. Here is every offence in the Act, what it can cost, and what to do if you find a gap.
Short answer: importing, exporting or placing an unregistered medical device in the Malaysian market is an offence under section 5 of the Medical Device Act 2012 (Act 737). On conviction the fine can reach RM200,000, the prison term can reach 3 years, or both. Doing so without an establishment licence is a separate offence with the same maximum under section 15.
Every offence and maximum penalty in Act 737
| Offence | Section | Fine up to | Prison up to |
|---|---|---|---|
| Importing, exporting or placing an unregistered device in the market | s.5(2) | RM200,000 | 3 years |
| Importing, exporting or placing a registered device in the market without an establishment licence | s.15(2) | RM200,000 | 3 years |
| Breaching the conditions of an establishment licence | s.19(2) | RM100,000 | 1 year |
| Assigning, sub-licensing or transferring a licence without MDA’s written approval | s.21(2) | RM50,000 to RM500,000 | 3 years |
| Continuing to trade after a licence is suspended, revoked, surrendered or not renewed | s.25(4) | RM200,000 | 3 years |
| Using or operating a designated device without a permit | s.27(2) | RM100,000 | 1 year |
| Breaching the conditions of a designated device permit | s.31(2) | RM50,000 | 6 months |
| Continuing to use a designated device after the permit is suspended, revoked, surrendered or not renewed | s.36(4) | RM100,000 to RM1,000,000 | 7 years |
| Failing to make a mandatory problem report | s.40(2) | RM200,000 | 2 years |
| Using, maintaining or disposing of a device in breach of the general duty | s.43(6) | RM100,000 | 1 year |
| Advertising an unregistered device, or making misleading or fraudulent claims | s.44(3) | RM300,000 | 3 years |
| Breaching the conditions of an export permit | s.45(5) | RM50,000 | 6 months |
| Obstructing or refusing information to an authorised officer | s.59 | RM500,000 | 3 years |
| Refusing an officer’s demand for a sample | s.65(3) | RM100,000 | 1 year |
| Making an untrue, inaccurate or misleading declaration or document | s.76(1) | RM100,000 | 2 years |
| Forging or knowingly using an altered registration, licence or permit | s.76(2) | RM500,000 | 3 years |
| Any other offence with no penalty stated | s.78 | RM500,000 | 3 years |
Each penalty applies on conviction, and the court may impose the fine, the prison term or both. Sections 21 and 36 set a minimum fine as well as a maximum. Read from the text of Act 737 as published by MDA. This is a summary, not legal advice.
What counts as placing a device in the market
Act 737 defines it as making a device available, in return for payment or free of charge, with a view to distributing, using, supplying or putting it into service in Malaysia, whether the device is new or reprocessed. So free samples and donated units can count. Making a device available for clinical research or for performance evaluation is excluded.
Who can be charged
- The person or company supplying the device. Section 5 applies to any person, not only licensed establishments.
- Directors, managers and company secretaries. Under section 73 they may be charged with the company, and are deemed guilty if it is convicted unless they prove lack of knowledge, consent or connivance and that they took all reasonable precautions and exercised due diligence.
- Employers and principals. Under section 74 a person is liable for the act of a partner, agent or servant, subject to the same defence.
What enforcement looks like
On 14 April 2026, MDA reported two raids on companies in Shah Alam, carried out with the Malaysian Rubber Board. One company was suspected of breaching sections 5 and 15, by placing unregistered devices in the market and operating without the required licensing. The other was suspected of distributing devices without a valid licence under section 15. Officers seized examination gloves and related documents worth about RM50,000 in total, and MDA said the cases would proceed to prosecution.
MDA’s powers go beyond a fine. Officers can search and seize with a warrant (section 51) or without one (section 52) and can arrest (section 64). Seized goods and records are liable to forfeiture (section 63), and costs or damages for a seizure cannot be recovered unless it was made without reasonable cause (section 57).
There is also a commercial cost. Under MDA Circular Letter No. 1/2026, a healthcare facility buying through a government or private tender must collect the tenderer’s distributor licence, the device registration certificate and the appointment letter from the authorised representative or distributor.
Compounding and prosecution
Section 71 lets MDA, with the Public Prosecutor’s consent, compound an offence that regulations prescribe as compoundable, for up to 50% of the maximum fine. The offer can be made any time before prosecution begins, and once an offence is compounded no prosecution can follow for it. Under section 72, any prosecution needs the Public Prosecutor’s written consent.
When an unregistered product is not an offence
- It is not a medical device. See what counts as a medical device and our borderline products list.
- It falls under an exemption. See all 12 exemptions, including custom-made devices, special access, personal use, exhibitions and demonstrations and import for re-export. Most carry conditions, and some need MDA’s approval first.
If you find you have been supplying an unregistered device
- Hold further supply of the affected stock until its status is clear.
- Confirm it is a medical device. If it is unclear, MDA can issue a classification letter.
- Check for an exemption and whether its conditions were met.
- Check the registration and who holds it. Use MDA’s public search. The registration must cover your exact model.
- Check your own licence and role. Importers, distributors, manufacturers and authorised representatives each need the establishment licence for that role.
- Register through the right route, starting with the documents checklist.
- Take legal advice if MDA, a customer or a competitor has already raised it. Registering a device later does not by itself undo earlier supply.
For a wider overview of the law, see this guide to the Medical Device Act 2012 (Act 737).
Apakah hukuman menjual peranti perubatan yang tidak berdaftar di Malaysia?
Di bawah seksyen 5 Akta Peranti Perubatan 2012 (Akta 737), mengimport, mengeksport atau meletakkan dalam pasaran peranti perubatan yang tidak berdaftar ialah suatu kesalahan. Jika disabitkan, denda boleh mencecah RM200,000, penjara sehingga 3 tahun, atau kedua-duanya. Beroperasi tanpa lesen establismen ialah kesalahan berasingan di bawah seksyen 15 dengan hukuman maksimum yang sama. Pengarah dan pengurus syarikat juga boleh didakwa di bawah seksyen 73. WhatsApp 010-206 2070.
Frequently asked questions
What is the penalty for selling an unregistered medical device in Malaysia?
Is giving away an unregistered device also an offence?
Can a company director be charged personally?
Does the penalty apply to online sellers?
Is having no establishment licence a separate offence?
Can MDA settle the offence without going to court?
Can MDA seize our stock?
Is every unregistered product an offence?
Found a gap in your product list?
Tell us what you sell and how you bring it in. We will work out what needs registering or licensing, in what order, and handle the applications.