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GDPMD MALAYSIA - ISO13485 CONSULTANT
MEDICAL DEVICE REGISTRATION. 3 MAJOR STEPS ONLY.
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
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.
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.
+6011 2410 2070
STEP 1 : ESTABLISHMENT LICENSE
TYPES OF ESTABLISHMENT LICENSE
AUTHORISED REPRESENTATIVE, IMPORTER & DISTRIBUTOR
RM 25,000
INCLUDED
- GDPMD cert - including CAB fees
- Establishment License submission - including Medc@st and MDA fees
- Compliance cost to GDPMD requirement not included
IMPORTER & DISTRIBUTOR
RM 18,000
INCLUDED
- GDPMD cert - including CAB fees
- Establishment License submission - including Medc@st and MDA fees
- Compliance cost to GDPMD requirement not included
GDPMD ONLY
RM 10,000
INCLUDED
- GDPMD cert - including CAB fees
- Compliance cost to GDPMD requirement not included
+6011 2410 2070
STEP 2 :
PRODUCT REGISTRATION
TYPES OF PRODUCT REGISTRATION
CLASS A
RM 2500 - ONE OFF
INCLUDED
- Document preparation
- MDA fees
- Follow up to MDA Enquiries
- Compliance cost not included
CLASS B
RM 6000 - ONE OFF
INCLUDED
- CSDT preparation
- CAB fees MDA fees
- Follow up to MDA Enquiries
- Compliance cost not included
CLASS C
RM 9800 - 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
+6011 2410 2070
STEP 3 :
RENEWAL
TYPES OF RENEWAL
GDPMD ANNUAL RENEWAL
RM 2500 - ANNUALLY
INCLUDED
- Document preparation
- CAB fees
- Compliance cost not included
ESTABLISHMENT LICENSE RENEWAL
RM 9000 - EVERY 3 YEARS
INCLUDED
- Documentation preparation
- CAB fees MDA fees
- Follow up to MDA Enquiries
- Compliance cost not included
PRODUCT REGISTRATION RENEWAL
RM 6000 - EVERY 5 YEARS
INCLUDED
- Document preparation - product return record
- CAB fees MDA fees
- Follow up to MDA Enquiries
- Compliance cost not included
+6011 2410 2070
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