Malaysia · Product registration
Local product holder in Malaysia
Malaysia issues product approvals only to locally incorporated companies, so a foreign company needs a local product holder. Who holds it decides how much control you keep over your products.
Overview
Understanding the local authorised representative role
A local product holder is the Malaysian entity that holds your product approval when you have no company of your own in the country. The NPRA and the Medical Device Authority issue registrations only to locally incorporated entities, so a foreign manufacturer registers through a local representative instead.
The holder is the entity on record. It is accountable to the regulator for the product, named on the registration, and responsible for keeping it current. Under the Control of Drugs and Cosmetics Regulations 1984, that entity must be incorporated with the Companies Commission of Malaysia, keep a permanent local address, and carry a health or product-related business scope.
Because the approval is tied to one holder, the choice of holder is a commercial decision as much as a regulatory one.
By product
Types of holders by product category
Malaysia splits the holder role across regulators, so the title depends on the product.
| Role | Regulator | What it holds |
|---|---|---|
| Product Registration Holder (PRH) | NPRA | Registration (MAL number) for medicines, supplements, and traditional products |
| Cosmetic Notification Holder (CNH) | NPRA | The notification for a cosmetic product |
| Authorised Representative (AR) | Medical Device Authority | The registration for a medical device, alongside an establishment license |
Different names, one principle: a locally incorporated entity holds the approval on behalf of the foreign company.
Your options
Ways to hold your approval
Every route puts the approval with a Malaysian entity. They differ in how much control you keep.
Your own Sdn Bhd
You set up a Malaysian company and hold the approval yourself. This gives full control over registration and distribution, but it carries the capital and upkeep of a company.
A distributor as holder
Your distributor holds the approval. It is the cheapest way in, but the registration sits with them, which ties your market access to one partner.
An independent holder
A neutral party such as Emerhub holds the approval and does not compete as your distributor. You keep control of the registration and can appoint or change distributors freely.
Keeping control
The risk of a distributor-held approval
The approval is what lets a product be imported and sold. When a distributor holds it, that asset sits on their side of the table. If the relationship ends or you outgrow them, you cannot simply take the registration with you; moving to a new holder generally means registering again under them.
An independent holder separates the approval from distribution. The registration stays in neutral hands, so you can run one distributor or several, replace an underperformer, or sell direct without putting your market authorisation at risk.
For medical devices, the holder’s licenses keep your product live. The Authorised Representative must keep a valid establishment license and GDPMD certification. If either lapses, the device registrations it carries are affected, so the holder’s compliance is your compliance.
Responsibilities
What the holder is responsible for
Holding the approval is an ongoing duty, not a one-time filing.
- Holding the registration, notification, or device approval on record
- Filing the application, renewals, and variations
- Keeping labels and packaging matched to what was approved
- Acting as importer of record where the setup requires it
- Meeting post-market and safety-reporting duties for the product
- Being the point of contact for NPRA or MDA queries and audits
- Maintaining its own licenses, such as the establishment license and GDPMD for devices
The process
How Emerhub holds your approval
From appointment to a registration that stays in your control.
Step 1 — Appoint Emerhub
You authorise Emerhub as your local representative for the products in scope, through a letter of authorisation.
Step 2 — Register or notify
We register or notify your product under our licensed Malaysian entity and hold the resulting approval as your PRH, CNH, or AR.
Step 3 — Maintain compliance
We handle renewals, variations, labeling checks, and the reporting each regulator requires.
Step 4 — Keep distribution open
You appoint, change, or run several distributors while the approval stays in neutral hands.
Where this applies
Every product track needs a local holder
The holder sits behind each of these approvals.
NPRA, as PRH
NPRA product registration
Medicines, health supplements, and traditional products. The PRH holds the MAL registration.
NPRA registrationNPRA, as CNH
Cosmetic notification
Cosmetics, which are notified rather than registered. The CNH holds the notification.
Cosmetic notificationMDA, as AR
Medical device registration
Devices and IVDs. The Authorised Representative holds the registration and an establishment license.
Medical devicesCommon questions
Local holder questions
What foreign companies ask about holding an approval.
Can a foreign company hold a Malaysian product approval directly?
No. The NPRA and the MDA issue approvals only to locally incorporated Malaysian entities. A foreign company holds its approval through its own Malaysian company or through a local product holder.
What is the difference between a PRH, a CNH, and an AR?
They are the same role under different regulators. The Product Registration Holder holds NPRA registrations for medicines and supplements, the Cosmetic Notification Holder holds cosmetic notifications, and the Authorised Representative holds medical device registrations with the MDA.
What happens if my distributor holds the approval?
The approval sits with them for the life of the arrangement. Moving to another distributor generally means registering again under the new holder, so a distributor-held approval ties your market access to one partner.
Does an independent holder control my product?
No. You keep ownership of the product and your commercial relationships. An independent holder such as Emerhub holds the approval in neutral hands and does not compete as your distributor, so you can change distributors without losing the registration.
What must a local product holder meet to qualify?
Under the Control of Drugs and Cosmetics Regulations 1984, it must be incorporated with the Companies Commission of Malaysia, keep a permanent Malaysian address, and carry a health or product-related business scope. For devices, it also needs an establishment license and GDPMD certification.
On the ground in Kuala Lumpur
Talk to our Kuala Lumpur team
Tell us the product, the regulator it falls under, and the distribution arrangements you have today. Our Kuala Lumpur team holds your approval in neutral hands and keeps the registration in your control as your channel arrangements evolve.
Emailmalaysia@emerhub.com
Phone / WhatsApp+60 17 684 9718
OfficeC-18-6, KL Trillion
Kampung Datuk Keramat
50400 Kuala Lumpur, Malaysia
Kampung Datuk Keramat
50400 Kuala Lumpur, Malaysia