Showing an unregistered medical device in Malaysia: exhibitions, demos and training.

What the demonstration and education exemption allows.

Paragraphs 3(1)(b) and 3(1)(c) of the Medical Device (Exemption) Order 2024 (P.U. (A) 78) exempt a medical device from registration under section 5 of Act 737 when it is imported or supplied for demonstration for marketing or for education. The exemption is conditional: the importer or supplier must apply to MDA first (paragraph 3(2)(a)). MDA’s procedure is MDA/GD/0018: a notification in MeDC@St at least 14 working days before import or supply, an RM300 charge, and an acknowledgement letter from MDA. A demonstration may run for up to 90 days from the date of import, the device must never be used on people, and free samples are banned.

GD/0018 is still the First Edition of November 2019, written under the 2016 Exemption Order. The 2024 Order, which MDA says took effect on 5 March 2024, kept both exemptions, and MDA’s demonstration and education page (uploaded 24 November 2025) still points to GD/0018 as the procedure.

The exemption at a glance

What counts as demonstration, and what counts as education

The applicant must first be sure the product is a medical device. GD/0018 says products that do not meet the definition are not eligible, and points to MDA/GD/0006 and MDA’s product classification application; see our definition guide and classification guide. The form also asks for the device’s class and classification rule.

IVD demonstrations

For in-vitro diagnostics, GD/0018 lets the demonstration include reliability or quality testing, where the results are used only to build trust and confidence in the device. Those results cannot be used to support or reject a patient’s diagnosis or treatment. Running a new analyser or rapid test on real patient samples to report results is outside the exemption; that needs registration, or the separate performance evaluation exemption in paragraph 3(1)(e) of the Order. See our IVD registration guide.

Who files, and whether you need a licence

• Any person, company or organisation that wants to import or supply the device for demonstration or education can be the applicant (GD/0018 clause 3.1). The introduction says the manufacturer or importer makes the notification.
• No establishment licence is required. Paragraph 4 of the Order exempts a person who imports or exports an exempted device from the licence under section 15(1) of Act 737, with special access devices as the only exception. The form has a “Role of Establishment (if applicable)” section for applicants who already hold a licence.
• A person responsible signs. The declaration is made by someone from top management with overall control and authority to decide: a proprietor, president, vice president, director, CEO, managing director, general manager or manager. A contact person can be appointed to deal with MDA.
• Foreign exhibitors. The form asks for the organisation’s address with a Malaysian state and city. In practice a foreign manufacturer files through its Malaysian importer, distributor or authorised representative. If you have no Malaysian entity, ask MDA (demo.edu@mda.gov.my) before you book freight.

The demonstration notification in MeDC@St

The applicant creates a MeDC@St 2.0 account with “Notification” as the reason, then fills in the demonstration form. Table 2 of GD/0018 sets out what it asks for:

The quantity must suit the declared purpose, and the applicant justifies it (clause 5.2.1(f)). A demonstration unit or two per booth is easy to justify; a container load is not.

The education notification

The education form (GD/0018 Table 3) asks for the course or training programme name, the centre, its full address, the department, faculty or school where the device will be placed, and the person in charge. Three things set it apart from the demonstration route:

• A justification. The applicant explains why the training is needed and why it has to be that specific device. GD/0018 states that there shall be no similar medical device available in the Malaysian market.
• Multiple shipments. The approved quantity may arrive in several shipments, and each later shipment must arrive within 180 days of the acknowledgement letter.
• No fixed period or post-handling step. GD/0018 gives the 90-day period, the extension and the post-handling notice only for demonstrations, and MDA’s education process flow ends at the acknowledgement letter. The clause 7 duties still apply, so keep records of where each device is and what happens to it.

Step by step

If MDA rejects the notification, or it lapses for want of a reply, the RM300 is not refunded, but a fresh notification may be made (clause 6.3). Work back from the shipping date, not the show date: 14 working days is close to three calendar weeks, and longer across public holidays.

Other agencies still apply

The MDA acknowledgement covers Act 737 only. Clause 5.1 of GD/0018 says the applicant must still comply with other Malaysian laws, and gives two examples:

• Customs. Import procedures and declarations go through the Royal Malaysian Customs Department. MDA’s medical device import permit, now due for enforcement from 1 July 2027, is a separate per-shipment control. MDA’s import permit page lists an RM130 fee for all purposes except sample investigation and does not list demonstration imports as exempt, so check the permit position before a 2027 event.
• Radiation. For irradiating apparatus, such as X-ray equipment, GD/0018 refers applicants to the Atomic Energy Licensing Board (AELB) for its demonstration and exhibition procedure.

Rules at the booth

Clause 7 of GD/0018 makes the applicant fully responsible for the unregistered devices during the demonstration or education period:

• The devices are used only for the purpose declared in the notification.
• Each device is prominently marked with a label or sign reading “For Demonstration or Education Purpose Only. Not For Use On Human”.
• The devices are not used on people, and not used to give results or information that support or reject any patient’s diagnosis or treatment.
• The applicant follows MDA’s directions and allows MDA to inspect at any time without notice.
• All information about the devices is kept at the premises and produced on MDA’s request.
• No free samples.

Promotion is allowed within limits. GD/0018 Table 1 permits posters, notices, brochures, pamphlets, banners, buntings, photographs and video clips during the demonstration period, with limited information specifically on the device’s specifications and features. Section 44 of Act 737 still bans advertising a device that is not registered, with a fine of up to RM300,000, up to three years’ imprisonment, or both, and the Exemption Order exempts the device from section 5, not section 44. Our reading is to keep the booth material to specifications and features, avoid performance claims, and not run public advertising, social media campaigns or online listings for the device outside the event. More on the advertising rules is in our advertisement approval guide.

MDA may withdraw the acknowledgement if the terms or duties are breached (clause 6.4). A device that is supplied or used outside the exemption is an unregistered device, and section 5 of Act 737 carries a fine of up to RM200,000, up to three years’ imprisonment, or both.

Extending a demonstration

A roadshow that runs past 90 days uses an extension, which GD/0018 calls a subsequent notification (clause 5.2.2). It follows the same procedure as a new notification, though some device documents may not be needed again. It must be filed at least 14 working days before the first notification expires, it is granted for up to 90 days, and the demonstration location must differ from the first notification. GD/0018 describes one extension; it does not describe a second. Clause 6.1 charges RM300 for each notification, so budget for a second charge.

When the demonstration ends

After the demonstration period, the applicant files a post-handling notice in MeDC@St no later than 30 days after the period ends and keeps the records as proof (clause 5.2.3). The system emails an acknowledgement of the notice. The form offers four outcomes, each with its evidence:

Demonstration units cannot be sold, donated or left with a hospital while they are unregistered. If you want to keep supplying the device after the show, start the registration early; for a device with a recognised foreign approval the verification route is usually the fastest.

Which route fits what you want to do

Our reading

• The deadline is the shipping date. The 14 working days run to the date of importation or supply, not to the opening day of the event.
• List every site. One demonstration notification can cover several devices and locations, but each site and its quantity has to be in the form. A device moved to an unlisted venue is outside the acknowledgement.
• Plan the exit before the entry. Decide whether the units will be re-exported, destroyed or registered, and keep the customs or disposal paperwork for the post-handling notice.
• Use the event, not the exemption, to start registration. A product that draws interest at a show can only be sold once it is registered. The CSDT, classification and authorised representative take longer to arrange than a 90-day demonstration lasts.