ISO 13485

Trusted by Medical Experts

 

Let our expertise streamline your journey towards compliance.

Structured & Transparent Workflow & Fee

Our clear project roadmap ensures timely execution, accurate documentation, and full compliance — without unnecessary delays and fee. It's transparent. No surprise fee.

End-to-End MDA Regulatory Support

From gap analysis to final audit, we provide
full-spectrum guidance tailored to MDA requirement.

Experienced Industry Professional

Our consultants bring hands-on experience in medical device distribution, regulatory affairs, and quality management system.

We can guide

Clear Workflow

Step 1: Get ISO13485 Certified

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)

Step 2: Establishment License (With MDA)

Applying for Manufacturer License

Step 3: Product License (With MDA)

Clarify if your product falls under Class A, B, C or D.

Step 4: Let's Rock The Market!

You can now start selling it!

We can guide

Fee and Duration

Step 1: Get ISO13485 Certified (estimated 2 months)

Step 1.1 (Consultation fee) :
1. Brand Owner (OEM) : RM19,000 + 8% SST
2. Manufacturer : RM35,000 + 8% SST
Step 1.2 (Audit fee) : pls refer to the FAQ below, Q2.

Step 2: Establishment License (estimated 1 month)

Step 2.1 (Consultation fee) : inclusive
Step 2.2 (MDA Establishment License fee) : RM4250

Step 3: Product License

Step 3.1 (Consultation fee) :
1. Class A: RM5000 + 8% SST / device (estimated 1 month to get MDA approval)
2. Class B: RM9000 + 8% SST / device (estimated 3 months to get MDA approval)
3. Class C: RM9000 + 8% SST / device (estimated 6 months to get MDA approval)
4. Class D: RM9000 + 8% SST / device (estimated 7 months to get MDA approval)
Step 3.2 (MDA Product License fee) : pls refer to FAQ 3

Conclusion For Fee Structure

YEN (Consultant)

You pay YEN for:

  1. Consultation fee to get ISO 13485
  2. Consultation fee to get your product registered with MDA

CAB (Auditor)

You pay CAB for:

  1. Audit fee for your ISO13485 certificate
  2. Audit fee for product that falls under Class B, C, D 

MDA (Authority)

You pay MDA for:

  1. Establishment License fee
  2. Product License fee

We Don't Just Consult, But Also Build IR4.0 Factory That Lasts For You

We can consult on your production layout, design, build and maintain for you.

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Yen

IR4.0

FAQ

Clear Your Doubts

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 

  1. Awareness training 
  2. Internal audit training
  3. Documentation 
  4. Management review 

Yes we do. You can come back to us when you are going for 2nd year audit. 

Fee: RM13,000 + 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: RM5000 + 8% SST

2. Class B, C, D: RM9000 + 8% SST 

Upon confirmation and pay 10 days before the commencement: 

  • Step 1: Pay for ISO13485 Consultation 
  • Step 2: Pay for Medical Device Registration Consultation

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. 

Mr Julian Saik Weng Kong

Executive Director of AZ GROUP OF COMPANIES

作为一家中国公司，我们选择了该团队提供医疗器械GDPMD（良好分销规范）合规咨询服务。其展现了卓越的专业能力。他们凭借对马来西亚法规的深刻理解，为我们提供了务实的解决方案。团队响应迅速，服务细致，帮助我们快速完成认证流程。特别感谢他们的专业指导。对于想要来马来西亚出口医疗器械的中国公司，我们推荐有医疗器械分销合规需求的企业选择该团队！

Mr Owen

Hytech SDn Bhd 董事经理

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