What is considered as medical device?
A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for a medical purpose.
Who can register a medical device in Malaysia?
All medical devices that are imported, exported or placed on the market in Malaysia whether manufactured domestically or not, must be registered with the Medical Device Authority (MDA) before they can be supplied in Malaysia.
Only companies registered locally in Malaysia with the Companies Commission (SSM) (government authority responsible for company registrations) may apply to obtain an establishment license, register a medical device and apply for an export permit.
(3) possibilities to register their medical device in Malaysia:
1.) Set up a legal subsidiary entity
2) Appoint a local importer or distributor
3) Appoint an independent Authorized Representative who has valid Medcast register account and act directly on behalf of foreign manufacturer or distributor.
General grouping of medical device.
Medical devices that can be grouped into one of the following five categories can be submitted in one application for medical device registration and listing in the Malaysia Medical Device Register (MMDR):.
Basic rules must all be fulfilled for the grouping to apply. These are:
a) one generic proprietary name;
b) one manufacturer; and
c) one common intended purpose
Single
Family
System
Set
IVD Test Kit
IVD Cluster
What document is required to register medical device?
Common Submission Dossier Template (CSDT) or Summary technical Document (STED) which includes an
- ISO 13485 Certificate
- executive summary
- device description & prescription
- any pre-clinical studies
- clinical evaluation
- device labelling
- instructions for use
- a risk analysis
- proof of quality management system
- manufacturing information
- essential principle checklist
- declaration of conformity
- any existing regulatory approvals
- product verification & validation
- Risk Analysis & Control Summary
Medical device registration certificate
What PS Consultancy & Training can do for you?
01
Consult & submit the registration
We prepare everything include classifying device, compiling all the documents, do the registration.
02
03
Deal with CAB & MDA
Liaison with the local authorized government agency on all regulatory issues relating to your medical device including amendment and change notifications
Independent Authorized Representative
We act directly behalf of your company, register, renew and maintain you device license. You can appoint as many importer as you want.
