Registered first, then imported
In Malaysia, a medical device must be registered with the Medical Device Authority (MDA) before it is imported or put on the market. Only a licensed company registered in Malaysia may import, export, or place it on the market. So Malaysia receives medical equipment through a licensed importer, and we ask for its name early. An overseas manufacturer appoints a Malaysian agent for this, an authorised representative, under a letter of authorisation. So the first questions on any quote are whether the model is registered and who will import it.
Our name is MediGear. From our registered company in England and Wales, we act as a medical equipment distributor for healthcare buyers in more than 80 countries, with quotes, documents and freight. For hospital equipment and supplies in Malaysia, we look for verified manufacturers whose models are registered with MDA, or whose Malaysian agent can register them. Then the quote goes to your engineers and buyers with each point below answered. Requests go through our buyers page, and you do not need an account.
MOH hospitals, teaching hospitals and private groups
Buyers we quote for include:
- MOH hospitals such as Hospital Kuala Lumpur
- Teaching hospitals such as UMMC
- Institut Jantung Negara, the heart institute
- Private groups such as KPJ and their operating theatres
- Sunway Medical Centre, which is adding five centres
- Dental practices with digital radiography and X-ray units
- Malaysian importers and distributors, laboratory equipment suppliers among them
Device imports go through a licensed company, whether you run a public healthcare facility in Malaysia or a private group. MDA's Circular 1/2026, on how healthcare institutions buy devices, took effect on 28 January 2026, and ePerolehan is the government's e-procurement system. A dental practice that needs just one replacement unit only has to send the model. Medical equipment suppliers in Malaysia that hold the licence can also ask us for quotes.
MDA registration, establishment licences and GDPMD
The Medical Device Act 2012 (Act 737) covers devices, and a second act of 2012 set up MDA, which has been fully operational since June 2012. Manufacturers, importers, and distributors need an establishment licence, as does the Malaysian agent of an overseas manufacturer. Applications go through MDA's online system, and licences have been issued online since 5 June 2024. Agents, importers and distributors must also meet good distribution practice for medical devices, known as GDPMD.
We are not a Malaysian importer, distributor or authorised representative, and we give no regulatory advice. Every quote states what the manufacturer tells us about the model's MDA status, and it lists the unit's certificates. Registration applies to every device, including diagnostic imaging systems such as a magnetic resonance imaging unit.
BKRP licences after the 2025 amendment
Since 1 December 2025, the amended Atomic Energy Act 1984 (Act 304) has applied, and the former licensing board has been dissolved. For medical uses, the Director General of Health grants licences. The Ministry of Health's Medical Radiation Surveillance Division enforces the Atomic Energy Licensing Act 1984. The division is known as BKRP, and it is the body to ask about a medical licence. A licence is needed to deal with a radiation generator, and this includes buying, owning, using, testing, servicing, and selling one. Licences now run for at least one year and up to forty years, and those issued by the former board remain in force.
Atom Malaysia's licence classes include class C for radiation apparatus and class E for import and export, while class H covers other work, such as installing, testing and servicing. The licence application includes a room layout, including shielding and where the equipment sits. Every licensee employs a radiation protection officer. BKRP aims to decide most complete new and renewal files within seven working days.
240 V supply, installers and service support
Before we quote Malaysian diagnostic imaging equipment, we settle these points with the manufacturer:
- Sockets. The old IEC tables give 240 V at 50 Hz and list type G plugs, so we confirm the power module and plug first.
- Installer. Installing, testing and servicing an X-ray unit is class H work, so a licensed service company does it, and its staff hold competence certificates.
- Parts. For refurbished medical imaging devices, MDA's good practice asks for parts and support over the planned life of the unit, and spare parts and consumables can ship with the order.
- Permit data. The X-ray import permit asks for the kV, mA and kW ratings and the serial numbers of the control panel and tube head, so we obtain them from the manufacturer early.
Open points go to the manufacturer in writing before we quote, as an incorrect serial number or rating would delay the permit.
K1 declarations, permits and plant quarantine
The Royal Malaysian Customs Department takes the import declaration on the K1 form, filed online by an appointed customs agent, an AEO firm or a Direct User. Permits from other agencies must be in place before any import, and import records are kept in Malaysia for seven years. For X-ray or computed tomography, the importer holds a class A, C, or E licence and applies for an Atom import permit 14 days in advance, naming the end user. Our papers for each order:
- The invoice with its packing list
- Air waybill or bill of lading
- Certificate of origin, if it applies
- HS codes in line with the Customs Order
- The registration details and certificates
Malaysia reports that it applies ISPM 15 to imports. The Department of Agriculture enforces the Plant Quarantine Act 1976. MAQIS, the quarantine and inspection service, runs plant checks at entry points. In Sarawak, imported wood packing must be debarked, treated and marked for good, with no stickers. We ask manufacturers for heat-treated, stamped crates, and importers also check the Customs (Prohibition of Imports) Order 2023.
Port Klang, Tanjung Pelepas and Penang
- Share the details. Send the model, quantity, site, and importer via the RFQ form or email.
- Check the registration. For catalogue items, expect a reply within 48 hours outlining certification, lead time, the port,t and the model's MDA status.
- Approve it. We order from the manufacturer only after your written approval.
- Ports and KLIA. Sea freight into Northport at Port Klang, Tanjung Pelepas or Penang Port at Butterworth, or air freight into Kuala Lumpur International Airport, the MASkargo hub.
Our delivery stops at the port or airport you nominate, where your customs agent lodges the K1 declaration with any permits, and the last leg is yours. Because Europe-to-Asia sailings can be rerouted at short notice, we confirm the routing when you order. Tanjung Pelepas has 14 berths and can handle up to 12.5 million TEU a year.
Single units, new centres and refurbished units
On most catalogue lines, a Kuala Lumpur hospital or a Penang clinic can order a single patient monitor, or one interventional X-ray and fluoroscopy unit, and receive a full quote. For new centres, see clinic setup, and eye teams can browse ENT, Ophthalmic and Sensory. Our refurbished range covers pre-owned units, including imaging devices. MDA has its own guidance on refurbished medical devices, including its Good Refurbishment Practice of Medical Devices. The manufacturer, or a company it authorises, carries out the work; the unit stays within its original registration and is labelled as refurbished, with the date. Its warranty should match that of a new unit. We found no MDA ban on used imports, but your importer should check the current rules before you order.
Disclaimer
This page provides general guidance for buyers in Malaysia and is not an offer to supply or legal, regulatory, or customs advice. What we quote depends on the manufacturer, and an order binds both sides only once agreed in writing. Devices need MDA registration and a licensed importer, and X-ray units need BKRP licences and an import permit. Your importer and customs agent handle clearance and the rules, as we are not a Malaysian importer or licence holder.
Is the device registered with MDA?
A device needs MDA registration before import, and only a licensed Malaysian establishment may bring it in. Send the model, the site and your importer's name, and we'll quote with the certificates, the registration status and the route.
Frequently Asked Questions
You can send any model number or specification to connect@medigear.uk or use the RFQ form on the buyer's page; no account is required. We quote for MOH and teaching hospitals, private groups, dental practices and Malaysian importers and distributors.
Yes. MDA requires registration before a device is imported or placed on the market, and only a licensed establishment, which must be a firm registered in Malaysia, may import it. An overseas maker registers through its Malaysian authorised representative, under a letter of authorisation.
The Director General of Health, through the Ministry of Health's Medical Radiation Surveillance Division (BKRP), under the Atomic Energy Act 1984 as amended from 1 December 2025. Atom Malaysia licenses non-medical uses, and licences issued by the old Board remain in force.
The applicant holds a class A, C, or E licence and applies 14 days before import through ePermit. The application names the end user and provides the unit's kV, mA, and kW ratings, as well as the serial numbers of the control panel and tube head.
Yes. Sea freight can go into Penang Port at Butterworth, Northport at Port Klang or Tanjung Pelepas, and smaller items can fly into Kuala Lumpur International Airport. Delivery is to whichever of these you nominate, and your agent clears the goods on arrival.
Imports are declared on the K1 form by an appointed customs agent, by an AEO company for itself or by a Direct User, and an agent needs written authority from its client. We supply the invoice, packing list, origin papers, HS codes, and the model's certificates for every consignment.
Yes. A single unit is quoted on most catalogue lines as usual, and our first reply mentions any minimum order from the maker. The model still needs MDA registration and a licensed importer, which we confirm with you before quoting.
MDA has its own refurbishment rules. The maker or a party it authorises does the refurbishment; the unit stays within its original registration, is labelled as refurbished with the date, and the warranty matches a new unit's. Your importer should confirm the current rules before you order.