Malaysia MDA

Malaysia Medical Device Registration

Fuelled by increasing demand for healthcare services, and emergence of new care models beyond traditional hospital settings, Malaysia is fast growing to be ASEAN’s largest medical device hub.Qualtech  is your ideal partner to for your foray into the Malaysia medical device market for an easy and smooth registration process.

Qualtech in Malaysia

GDPMD Certificate

We are Malaysia Government approved entity to process regulatory and distribution work of medical device. We successfully assisted foreign manufacturers to access local market.

200 Cases Approval

There are over 50 manufacturers entering Malaysia market with Qualtech local team support. Especially, we offer an efficient registration way for high risk products to open local market in a short time.

 

 

QT Services
 
 
 
 

Medical Device Registration

Our in – house experts are able to provide you with excellent professional service in preparing customized ASEAN Common Submission Dossier Template (CSDT) and liaise with MDA officers to get your devices registered in the Malaysia.

 
 

Authorized Representation

As an in – country authorized representative (AR), Qualtech can hold a medical device registration license on behalf of foreign manufacturers looking to market medical devices in the Malaysia. This is in compliance with the law for a local establishment to be a license holder.

 
 

Importation

The local distributor you are looking is sometimes not a qualified importer, or is not familiar with the importation process of medical device. Qualtech has extensive experience in importation in many regions of Asia, assisting several customers to handle customs clearance of various medical equipment imports. We can assist your products to be delivered to customers smoothly!

 
 

Establishment License Application

We also provide professional guidance and service for local manufacturers, importers, distributors and authorised representatives to apply for an Establishment License with MDA. Having a team of local consultants who are well-versed in the requirements of local regulations and MEDCAST system, your journey will be smooth with us.

 

Registration with MDA

The registration of medical devices in Malaysia is a two-stage process. The process is highly regulated by the Medical Device Authority (MDA) of Ministry of Health, Malaysia and verified by MDA-accredited third-party Conformity Assessment Body(s) (CAB). Foreign manufacturers (outside Malaysia) must appoint a Local Authorised Representative (AR) to manage device registration and authorize an importer and distributor to import and supply devices post approval. Only 1 local AR per Device Brand. However, a foreign manufacturer with multiple devices or device brands is allowed to appoint more than one AR.

Classification
 
 

 

Class A

Low risk device

Product Certificate

Online submission

Class B

Low-Moderate Risk

Product Certificate

Online submission

Class C

High-Moderate Risk

Product Certificate

Online submission

Class D

High Risk

Product Certificate

Online submission

 

 

TECHNICAL REQUIREMENTS

Qualtech CLASS A CLASS B CLASS C CLASS D
Executive Summary   Yes Yes Yes
Essential Principles and Methods   Yes Yes Yes
Device Description Yes Yes Yes Yes
Summary of Design V&V Yes Yes Yes Yes
Labeling and IFU Yes Yes Yes Yes
Risk Assessment   Yes Yes Yes
Physical Manufacturer Information Yes Yes Yes Yes
Clinical Evidence   Yes Yes Yes
PMS Plan and Report   Yes Yes Yes
QMS Audit Report Yes Yes Yes Yes

Note: Kindly see the MDA/GD/0008 COMMON SUBMISSION DOSSIER for more details.

 
Workflow
 
 

MDA Target Reviewing Turnaround Time

After successful internal evaluation of the submission dossier, our in – house experts will then submit it to the MDA and will be subjected to thorough evaluation. Below is a list of the turnaround times for different types of transactions involving product registration/notification.

  CLASS A CLASS B CLASS C CLASS D
CAB (Product Verification) NA 60 - 90 60 - 90 60 - 90
Registration 30 100 180 220
Compliance 90 90 90 90
  • Note:
  1. 1. It’s accounted as Working days.
  2. 2. CAB in Full Assessment would take around 8 months.
Validity
 
 
  • Types of Certificates: Product Certificate, CAB Certificate

  • Product Certificate: 5 years

  • CAB Certificate(product verification certificate & full assessment certificate): 5 years

 
Tips
 
 
How Could I Obtain Faster Market Access?

All foreign manufacturer would like to have their product access Malaysia market immediately. It’s a good news that MDA offers a route of faster market access to shorten the registration timeline.

For the Class B, C and D product:

If the manufacturer holds a product registration certificate from any of below reference countries, MDA-recognized CABs allow product conformity assessment via verification routes with shortened timelines, enabling faster market access.

 

MDA-recognized reference markets, including Australia, Canada, European Union countries with CE mark, Japan, and the United States. The manufacturer shall provide the local product certificate to verify the product is allowed on market.

 

For more information, please refer to the MDA’ official website or you may contact us for a free consultation.

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Official Website
 
 

 

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