You pay “per project”, not “per man-day”. It's transparent. No surprise fee
We can help you to apply for Establishment Licence and Product Licence
Let the professional consultant guide you as we have more than 15 years of experience
Step 1.1: Let consultant to help you guys setting up the docs and training first
Step 1.2: Once ready, then we'll call in the external auditor to audit you guys.
Decide your role as an Authorised Representative, Importer, Distributor
Clarify if your product falls under Class A, B, C or D.
You can now start selling it!
Step 1.1 (Consultation fee) : RM5900 + 8% SST
Step 1.2 (Audit fee) : pls refer to the FAQ below, Q2.
Step 2.1 (Consultation fee) : we'll help you to apply for free
Step 2.2 (Establishment License fee) : You pay directly to MDA through their website
a) Authorised Rep: RM4250
b) Distributor: RM2250
c) Importer: RM2250
Step 3.1 (Consultation fee) :
1. Class A: RM1500 + 8% SST / device (estimated 1 month to get MDA approval)
2. Class B: RM3500 + 8% SST / device (estimated 3 months to get MDA approval)
3. Class C: RM3500 + 8% SST / device (estimated 6 months to get MDA approval)
4. Class D: RM3500 + 8% SST / device (estimated 7 months to get MDA approval)
Step 3.2 (MDA Product License fee) : pls refer to FAQ 3
You pay YEN for:
You pay CAB for:
You pay MDA for:
Nope, as it’s charged by another 3rd party independent audit firm.
1st year: RM6,000
2nd & 3rd year: RM4,000
4th year (re-cert year): RM6,000
It’s ± RM1500.
5 years, just like the product license.
Class A: RM100
Application fee + License Fee
Class B: RM250 + RM1000 = RM1250
Class C: RM500 + RM2000 = RM2500
Class D: RM750 + RM3000 = RM3750
New application
AR = RM4250
Distributor = RM2250
Importer = RM2250
Renewal
AR = RM2200
Distributor = RM1200
Importer = RM1200
For GDPMD: every year
For Establishment License: 3 years
For Product License: 5 years
Upon confirmation and pay 10 days before the commencement:
PS: Travelling allowance will be bare by client for out-of-Klang Valley consultation project.
Yes we do. You can come back to us when you are going for 2nd year audit.
Fee: RM3,900 + 8% SST / project
Duration: 2 days / project
Maintenance package is inclusive of:
a) review the readiness of the “audit documentation” for the upcoming assessment
b) assist on reflecting any changes / amendment that is necessary for documentation and process
c) advise / rectify any issue arise from previous assessment internally/externally
d) assist on conducting the internal audit
e) coordinate the audit between client & CAB
f) assist on replying NC (if any) followed with the Corrective Action implementation
Yes we do. You can come to us for this service.
Fee:
1. Class A: RM1500 + 8% SST
2. Class B, C, D: RM2500 + 8% SST
WhatsApp us at 0175709263 or fill up the form here
“I’m JULIAN SAIK WENG KONG , Executive Director of AZ GROUP OF COMPANIES. What I like about Yen Premium Coach is the consistent efforts and support throughout our whole process of obtaining the ISO 13485: 2016 quality standards certifications. The consultants are very professional and knowledgeable in our nature of business as well. The whole process took us less than 3 months and the management is very pleased with the efficiency from YEN Premium Coach.
Reducing Global Warming By 1.5°C Through ISO & IR4.0
