ISO13485 Registration in Malaysia - FAQ
GDPMD Malaysia - ISO13485 Consultant
Medical Device Consultant. 3 Major Steps Only!
1
Establishment License
We will meet and brief you, conduct site visit, point out non compliance, and suggest remedial solutions. Once kick off, we will work together to complete the process
2
Product Registration
Once Establishment License is completed, we will begin to work on products to register. We recommend CE certified products as abridge evaluation is much simpler.
3
Renewal
Renewal of quality menagement system is done annually, renewal of establisment license is every 3 years, product registration is every 5 years. Complete record and tracing is required.
Step 1
Establishment License
Types of Establishment License
Step 2
Product Registration
Types of Product Registration
Class A
RM 2,500 - One Off
INCLUDED
- Document preparation
- MDA fees
- Follow up to MDA Enquiries
- Compliance cost not included
Class B
RM 6,000 - One Off
INCLUDED
- CSDT preparation
- CAB fees MDA fees
- Follow up to MDA Enquiries
- Compliance cost not included
Class C
RM 9,800 - One Off
INCLUDED
- CSDT preparation
- CAB fees MDA fees
- Follow up to MDA Enquiries
- Compliance cost not included
For Class D and How to Classify Medical Devices into Classes, Please Contact Us
Step 3
Renewal
Types of Renewal
GDPMD / ISO13485
Annual Renewal
RM 2,500
(Annually)
INCLUDED
- Document preparation
- CAB fees
- Compliance cost not included
Establishment
License Renewal
RM 9,000
(Every 3 Years)
INCLUDED
- Documentation preparation
- CAB fees MDA fees
- Follow up to MDA Enquiries
- Compliance cost not included
Product Registration
Renewal
RM 6,000
(Every 5 Years)
INCLUDED
- Document preparation - product return record
- CAB fees MDA fees
- Follow up to MDA Enquiries
- Compliance cost not included
AA Alive Sdn Bhd
10 Jalan Perusahaan Amari, Amari Business Park, 68100 Batu Caves Kuala Lumpur
Tel: 1 2410 2070
Emel: contact@evin2u.com
MDA Establishment License: MDA-6798-K124