GPDMD Application

GDPMD Is Your Entry Ticket To Medical Device Industry

Let Us Be Part of Your New Venture !

No Hidden Charge

You pay “per project”, not “per man-day”. It's transparent. No surprise fee.

MDA Registration

We can help you to apply for Establishment Licence and Product Licence.

Highly Competent Consultant

Let the professional consultant guide you as we have more than 15 years of experience.

Step 1: Get GDPMD Certified

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.

Step 2: Establishment License (With MDA)

Decide your role as an Authorised Representative, Importer, Distributor.

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!

Step 1: Get GDPMD Certified (estimated 2 months)

Step 1.1 (Consultation fee) : RM5900 + 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) : 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: Product License

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

YEN (Consultant)

You pay YEN for:

1. Consultation fee to get GDPMD.

2. Consultation fee to get Product License with MDA.

CAB (Auditor)

You pay CAB for:

1. Audit fee for your GDPMD certificate.

2. Verification fee for product that falls under Class B, C, D.

MDA (Authority)

You pay MDA for:

1. Establishment License fee.

2. Product License fee.

FAQ

1. Is Audit Fee Inclusive?

Nope, as it’s charged by another 3rd party independent audit firm.

2. How Much is the Audit Fee (by CAB) for GDPMD?

1st year: RM6,000

2nd & 3rd year: RM4,000

4th year (re-cert year): RM6,000

2.1 How Much is the Verification Fee (by CAB) for Product That Falls Under Class B, C and D?

It’s ± RM1500

2.2 When Will the Product Verification Cert (for Class B, C & D) Expire?

5 years, just like the product license.

3. How Much is the Product License Fee (That's Charged by MDA) for Each Class?

Class A: RM100

Application fee + License Fee

Class B: RM250 + RM1000 = RM1250

Class C: RM500 + RM2000 = RM2500

Class D: RM750 + RM3000 = RM3750

3.1 How Much is the Renewal Fee for the Establishment License (Authorized REP, Distributor and Importer)?

New application
AR = RM4250
Distributor = RM2250
Importer = RM2250

Renewal
AR = RM2200
Distributor = RM1200
Importer = RM1200

4. What's the Validity Period for Each License?

For GDPMD: every year

For Establishment License: 3 years

For Product License: 5 years

5. How's the Payment Term (for Consultation)?

Upon confirmation and pay 10 days before the commencement:

Step 1: Pay for GDPMD Consultation
Step 2: Pay for Medical Device Registration Consultation

PS: Travelling allowance will be bare by client for out-of-Klang Valley consultation project.

6. What's Inclusive in Your Consultation?

1. Awareness training

2. Internal audit training

3. Documentation

4. Management review

7. Do You Provide "Maintenance Package" for Following Years?

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

8. How Shall We Start?

WhatsApp us at (60) 10 290 1182 or fill up the form here

Mentari Yakin Sdn Bhd (520648-P)

Block D-53-3A, Jaya One,
72, Jln Profesor Diraja Ungku Aziz, , Seksyen 13A, 46400 Petaling Jaya, Selangor 46400, Petaling Jaya Selangor
Malaysia