HRD Corp Claimable Courses · ISO 13485 · GDPMD · MDA

HRD Corp claimable training for medical device companies, paid from your levy.

ISO 13485, GDPMD, MDA registration and post-market surveillance courses, taught by the consultants who do the work. Take the course from your HRD Corp levy, then let the same team implement it for you. One programme, two invoices: training to HRD Corp, consultancy to you.

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Short answer: if your company pays the HRD Corp levy, our ISO 13485, GDPMD, MDA registration and PMS courses can be paid from that levy under the HRD Corp Claimable Courses scheme. HRD Corp caps general in-house courses at RM10,500 per group per day (January 2026 cost matrix). You apply for the grant before the course; we claim the fee from HRD Corp after it. The implementation work that follows (ISO 13485 from RM7,500, GDPMD with the licence RM5,500, registrations from RM3,800) is consultancy, billed at our published fees.

Courses

HRD Corp claimable courses for medical device teams

Course	For	Length	Leads into
ISO 13485:2016 Awareness and Requirements	Manufacturers, own-brand companies and contract manufacturers; all staff who work inside the QMS	1 day (7 hours)	ISO 13485 implementation
ISO 13485:2016 Internal Auditor	QA/RA staff and managers who will run the internal audit programme	2 days (14 hours)	ISO 13485 implementation
GDPMD Awareness and Internal Audit	Importers, distributors and authorised representatives; warehouse, QA, sales and service staff	2 days (day 1 awareness, day 2 internal audit) (14 hours)	GDPMD certification + establishment licence
MDA Medical Device Registration and CSDT Workshop	Regulatory affairs, QA and product staff at manufacturers, ARs and importers	1 day (7 hours)	MDA registration service
Post-Market Surveillance, Vigilance and Recall Workshop	Licence holders: QA/RA, service and customer-facing staff	1 day (7 hours)	PMS retainer

In-house at your premises or remote online. Every course is written for Malaysian medical device law (Act 737 and MDA guidance), not adapted from a general ISO course.

GDPMD Awareness and Internal Audit

2 days (day 1 awareness, day 2 internal audit). Importers, distributors and authorised representatives; warehouse, QA, sales and service staff.

Good Distribution Practice for Medical Devices and why the establishment licence depends on it
Premises and storage, stock handling, traceability and distribution records
Complaint handling, field corrective action, recalls and mandatory problem reporting
Running a GDPMD internal audit and management review before the CAB audit

MDA Medical Device Registration and CSDT Workshop

1 day. Regulatory affairs, QA and product staff at manufacturers, ARs and importers.

Act 737 basics: registration (s.5), establishment licence (s.15), who may hold a registration
Classification rules, grouping (MDA/GD/0005) and the conformity assessment routes, including verification
Building the CSDT section by section (MDA/GD/0008) and the essential principles checklist
MeDC@St submission and answering MDA “Require change” queries

Post-Market Surveillance, Vigilance and Recall Workshop

1 day. Licence holders: QA/RA, service and customer-facing staff.

Duties of establishments (Medical Device (Duties and Obligations of Establishments) Regulations 2019)
Complaint handling and distribution records (MDA/GD/0011, MDA/GD/0012 and its draft Second Edition)
Mandatory problem reporting under Act 737 s.40: 48 hours, 10 days, 30 days
Field corrective action and recall: deciding, notifying MDA, reconciling lots, closing out

The two ISO 13485 courses (awareness, and internal auditor) are set out in full on ISO 13485 training in Malaysia.

Training + consultancy

Packages: learn it from the levy, then we implement it

Training on its own leaves your team knowing what to do, with no time to do it. Each package below pairs the course (paid from your levy) with the project it prepares for (our published fee). Your staff sit the course with the consultant who then runs the project, so day one of the project starts from shared ground.

MANUFACTURERS

ISO 13485 package

From your levy: ISO 13485 awareness (1 day) + internal auditor (2 days)
Consultancy: ISO 13485 system + MDA manufacturer licence application, RM7,500 our fee
Paid direct: certification body audit RM7,500; MDA manufacturer licence RM4,250

Ask about the ISO 13485 package

IMPORTERS · DISTRIBUTORS · ARs

GDPMD + licence package

From your levy: GDPMD awareness and internal audit (2 days)
Consultancy: GDPMD certification + establishment licence submission, RM5,500 our fee
Paid direct: CAB audit RM4,785 per warehouse; MDA licence fee per role (distributor RM2,250)

Ask about the GDPMD package

REGISTRATION HOLDERS

Regulatory package

From your levy: MDA registration & CSDT workshop + PMS, vigilance & recall workshop (1 day each)
Consultancy: registrations all-in from RM3,800 per device, or outsourced regulatory affairs on a retainer
Paid direct: nothing extra for registrations (CAB and MDA fees included)

Ask about the regulatory package

Training and consultancy are separate contracts with separate invoices: the course fee is claimed from HRD Corp by MedTech Advisory PLT; consultancy is invoiced by AA Alive Sdn Bhd. Consultancy can be spread from RM1,500 a month.

How claiming works

From quotation to claim, step by step

Quotation. WhatsApp us the course, the number of trainees and the dates. We send a quotation with the course details and the claimable amount.
Grant application. You apply in e-TRiS at least one day before the course starts. Your levy account must be up to date, with no arrears or late-payment interest.
Approval. HRD Corp approves the grant against your levy balance.
Training. In-house or online. Trainees sign the daily attendance (T3) form and must attend at least 75% of the hours.
Declaration. A manager or above approves the Joint Declaration 14 (JD14) after the course.
Claim. We invoice HRD Corp and claim the course fee, which HRD Corp debits from your levy. As long as the fee is within the cap and your levy balance, none of it comes out of your cash budget.

HRD Corp limits on the course fee

Format (general courses)	HRD Corp maximum course fee
In-house, full day (at least 7 training hours)	RM10,500 per group
In-house, half day (up to 4 training hours)	RM6,000 per group
In-house with fewer than 5 trainees	Prorated, e.g. RM2,100 per trainee per day
Public course, full day	RM1,750 per participant
Remote online training	Treated the same as face-to-face, in-house or public

From HRD Corp’s Allowable Cost Matrix guidebook (January 2026 version). Industry specific and professional certification courses are paid as charged per participant. Meal or travel allowances follow the same matrix. We quote every course within the cap.

Who runs the training

Courses are delivered by MedTech Advisory PLT (202604002526), HRD Corp registered training provider and the training arm of AA Alive Sdn Bhd. The trainers are the consultants behind our 1,000+ MDA device registrations since 2016, our own MDA establishment licence and GDPMD-certified system, and a measured median of 53 days from submission to approval on our last 39 registrations. You learn the requirement from people who answer MDA queries every week.

Jawapan ringkas · Bahasa Malaysia

Adakah latihan ISO 13485 dan GDPMD boleh dituntut HRD Corp?

Ya. Kursus ISO 13485, GDPMD, pendaftaran MDA dan pengawasan pasca pasaran kami boleh dibayar daripada levi HRD Corp di bawah skim HRD Corp Claimable Courses. Had yuran kursus dalaman ialah RM10,500 bagi setiap kumpulan sehari (matriks kos Januari 2026). Majikan memohon geran dalam e-TRiS sekurang-kurangnya sehari sebelum kursus; kami menuntut yuran daripada HRD Corp selepas latihan. Kerja perundingan (ISO 13485, GDPMD, pendaftaran) dibayar mengikut yuran kami yang diterbitkan. WhatsApp 010-206 2070.

FAQ

Frequently asked questions

What does “HRD Corp claimable” mean?

The course is registered with HRD Corp under the HRD Corp Claimable Courses scheme, so an employer registered with HRD Corp can pay the course fee from its levy instead of its cash budget. You apply for the grant in e-TRiS, HRD Corp approves it, we run the training, and we then claim the course fee from HRD Corp ourselves, invoicing HRD Corp directly. Our courses are run by MedTech Advisory PLT, our HRD Corp registered training provider.

How much will HRD Corp pay for a course?

For general courses, HRD Corp’s Allowable Cost Matrix (January 2026) caps the course fee at RM10,500 per group per day for in-house training of at least 7 hours, and RM6,000 per group for a half day of up to 4 hours. Below 5 trainees the cap is prorated (for example RM10,500 ÷ 5 = RM2,100 per trainee). Public courses are capped at RM1,750 per participant per day. We quote within the cap, and your quotation shows the claimable amount before you apply.

Who can claim?

Employers registered with HRD Corp that have paid at least their first month of levy and have no levy arrears or late-payment interest, because HRD Corp debits the course fee from the accumulated levy. Registration is compulsory for employers with 10 or more Malaysian employees in the covered sectors, at a levy of 1% of monthly wages.

Can HRD Corp pay for ISO 13485 or GDPMD certification itself?

No. HRD Corp funds training. Consultancy (gap analysis, documentation, audit-day support, MDA submissions), the certification body’s or CAB’s audit fee and MDA’s licence and registration fees are not training costs, so they are paid in the normal way. That is why our packages separate the two: the courses from your levy, the implementation at our published fees.

How many people do we need for an in-house course?

At least 2 trainees for face-to-face in-house training (1 for remote online training). Below 5 trainees HRD Corp prorates the claimable course fee, so 5 or more makes the best use of the cap. Each trainee must attend at least 75% of the training hours for the claim.

Can the course be online?

Yes. HRD Corp now treats remote online training, in-house and public, the same as face-to-face training. Attendance is taken from the system and signed by both of us.

What paperwork does our company sign?

The grant application in e-TRiS before the course (at least one day before it starts), the daily attendance (T3) form during the course, and the Joint Declaration 14 (JD14) form, approved by a manager or above, after it. We prepare the T3 and JD14 and submit the claim with our invoice to HRD Corp.

Who delivers the training?

MedTech Advisory PLT (202604002526), the training arm of AA Alive Sdn Bhd. The trainers are the same consultants who run our MDA registrations, GDPMD and ISO 13485 projects. Since 1 January 2025 HRD Corp requires trainers in its ecosystem to hold HRD Corp Accreditation status.

Use your levy before you budget for training

Tell us the team and the course. You get the dates, the HRD Corp claimable amount and, if you want it, the implementation quote.

WhatsApp for HRD Corp training