You pay “per project”, not “per man-day”. It's transparent. No surprise fee
Let's do it RIGHT from the beginning (plant layout, space, machinery, air-ventilation, water system and etc)
We help to apply the Establishment License and Product License
We can guide
Step 1.1
Decide
1. If you are a Brand Owner (OEM) or a Full Manufacturer
2. On your production line and plant layout
Step 1.2: Get audited by CAB (external auditor)
Applying for Manufacturer License
Clarify if your product falls under Class A, B, C or D.
You can now start selling it!
We can guide
Step 1.1 (Consultation fee) :
1. Brand Owner (OEM) : RM12,000 + 8% SST
2. Manufacturer : RM19,000 + 8% SST
Step 1.2 (Audit fee) : pls refer to the FAQ below, Q2.
Step 2.1 (Consultation fee) : inclusive
Step 2.2 (MDA Establishment License fee) : RM4250
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:
We can consult on your production layout, design, build and maintain for you.
IR4.0
Nope, as it’s charged by another 3rd party independent audit firm.
For Brand Owner (OEM):
1st year: RM10,000
2nd & 3rd year: RM6,000
4th year (re-cert year): RM10,000
For Full Manufacturer:
1st year: RM10,000
2nd & 3rd year: RM6,000
4th year (re-cert year): RM10,000
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
For ISO 13485: every year
For Establishment License: 3 years
For Product License: 5 years
Yes we do. You can come back to us when you are going for 2nd year audit.
Fee: RM5,900 + 8% SST / project
Duration: 3 days / project
Maintenance package is inclusive of:
a) review the readiness of the “documentation for audit” 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: RM5,000 + 8% SST / project
Duration: Estimated 1 – 2 month
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
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 can. Let’s speak further on this.
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
