Regulatory affairs · MDA compliance · Retainer
Outsourced regulatory affairs for medical device companies in Malaysia.
Your MDA approvals run on a dozen different clocks. We run them for you: registrations and re-registrations, licence renewals, change notifications, advert approvals, tender documents, MDA queries and vigilance. One consultant who knows your file, on a retainer, instead of a hire you have to train and cover.
01 MDA Registration02 GDPMD + Licensing03 ISO 13485 QMS04 MDSAP05 CE / FDA Export
Short answer: most Malaysian device importers, distributors and SME manufacturers do not need a full-time regulatory affairs hire; they need nothing to lapse. We run the MDA compliance calendar, prepare and file every submission, answer MDA queries and handle vigilance, as a retainer quoted per portfolio, with project work at our published fees (registration from RM3,800 all-in, re-registration RM6,000 per 5 years).
The MDA compliance calendar for a device company
Every row below is a date that, if missed, stops sales, voids an approval or creates an offence. A regulatory affairs function exists to make sure none of them is missed.
| Duty | When | Basis |
|---|---|---|
| Device re-registration | Opens 1 year before the 5-year expiry; impossible after expiry | MDA re-registration notice; automated route from 13 July 2026 |
| Establishment licence renewal | Per role licence, before expiry | Act 737 s.15; one licence per role since 1 July 2024 |
| 2026 licence fee payments and reimbursement requests | By 14 December 2026 (MDA account closes 21 December) | MDA notice, 3 November 2026 |
| GDPMD surveillance and re-certification | Surveillance audits in years 2 and 3; re-certification every 3 years | CAB certification cycle |
| Change notification | Category 2: before the change is implemented; Category 3: on submission | MDA/GD/0020; 30 or 60 working days |
| Advertisement approval | Before any advert to the public; lapses when the registration expires | Medical Device (Advertising) Regulations 2019 |
| Mandatory problem reporting | 48 hours, 10 days or 30 days from discovery, by severity | Act 737 s.40 |
| Tender documents | Every tender, Government or private | Circular Letter No. 1/2026: licence, registration certificate, appointment letter |
| Import permit | Every shipment from 1 July 2027 | MDA announcement, 1 December 2025 |
What we take over
- Registrations: new devices (classification, CSDT, CAB, MeDC@St), re-registrations and grouping strategy
- Licences and certificates: establishment licence renewals per role, GDPMD surveillance and re-certification, MDA fee deadlines
- Changes: change notifications under MDA/GD/0020, labelling reviews, change of ownership when an AR changes
- Market-facing approvals: advertisement approvals, tender document packs under Circular Letter No. 1/2026, Certificates of Free Sale for export
- Post-market: complaint and distribution records, mandatory problem reports, field corrective actions and recalls (our PMS retainer)
- MDA correspondence: queries in MeDC@St, clarifications, and a short note to you whenever MDA changes a rule that touches your devices
- Local presence for foreign manufacturers: we can hold registrations as your authorised representative under our own MDA establishment licence
In-house hire or outsourced: how to decide
| In-house RA executive | Outsourced to us | |
|---|---|---|
| Best fit | Large portfolios with daily submissions, or a manufacturer with an active design pipeline | Importers, distributors, foreign brands and SME manufacturers with a steady portfolio |
| Cost | A full salary whether the month is busy or quiet | Retainer sized to the portfolio, plus published per-item fees |
| Cover | One person; leave and resignations leave gaps | A team that already knows your file |
| MDA experience | Whatever your hire has seen | 1,000+ registrations since 2016; median 53 days submission to approval on our last 39 |
Many clients do both: an in-house coordinator for tenders and sales support, with us on submissions, renewals and MDA queries.
How the work is priced
| Work | Our fee | Paid direct (not included) |
|---|---|---|
| Compliance calendar, MDA monitoring, correspondence, vigilance | Retainer, quoted per portfolio | None |
| New device registration, per device | RM3,800 (A) · RM6,800 (B) · RM9,800 (C) · RM12,000 (D) | None: CAB and MDA fees included |
| Re-registration, every 5 years | RM6,000 per registration | None: CAB and MDA fees included |
| GDPMD surveillance (years 2 and 3) | RM2,500/yr | CAB surveillance audit RM2,585/yr |
| GDPMD re-certification + licence renewal (every 3 years) | RM5,500 | CAB audit RM4,785 per warehouse; MDA renewal fee per role |
| Change notifications, advertisement approvals, CFS | Quoted per item, or inside the retainer | MDA charges: RM30–RM2,500 per change, RM1,000 per advert application, from RM100 per CFS |
Payment plans from RM1,500 a month. Quotations are itemised and usually issued within one working day.
Jawapan ringkas · Bahasa Malaysia
Apakah perkhidmatan hal ehwal regulatori (regulatory affairs) untuk syarikat peranti perubatan?
Kami mengurus kalendar pematuhan MDA syarikat anda: pendaftaran dan pendaftaran semula peranti, pembaharuan lesen establismen, pemberitahuan perubahan, kelulusan iklan, dokumen tender, pertanyaan MDA dan laporan masalah wajib. Kerja projek mengikut yuran yang diterbitkan (pendaftaran dari RM3,800, pendaftaran semula RM6,000); kerja berterusan secara retainer mengikut portfolio. WhatsApp 010-206 2070.
FAQ
Frequently asked questions
What does a regulatory affairs consultant do for a medical device company in Malaysia?
Keeps the company’s MDA approvals valid and its new products moving: device registrations and re-registrations, establishment licence renewals, change notifications when a device changes, advertisement approvals, tender documents, answers to MDA queries in MeDC@St, and the post-market duties under Act 737 (complaints, distribution records, mandatory problem reporting and recalls). Outsourcing means one firm runs that calendar for you instead of an in-house hire.
How much does outsourced regulatory affairs cost?
Project work is billed at our published fees: for example device registration RM3,800 (Class A) to RM12,000 (Class D) all-in, re-registration RM6,000 per registration every 5 years, GDPMD surveillance RM2,500 a year our fee. The standing work (compliance calendar, MDA monitoring, vigilance and correspondence) runs as a retainer quoted per portfolio, because a distributor with five Class A registrations and a manufacturer with forty Class C devices need very different coverage. You get the quote after we have looked at your registrations and licences.
Can you work alongside our in-house regulatory person?
Yes. Common set-ups are cover during leave or a resignation, taking the submissions so your RA executive can focus on quality and tenders, or a second check on dossiers before they go to the CAB or MDA.
Can you take over from our current consultant or authorised representative?
If the registrations are held by your own company, switching consultants needs no MDA filing; you give us the documents and access. If your current authorised representative holds them, moving them is a change of ownership under MDA/GD/0041: the new AR applies with the manufacturer’s new Letter of Authorisation, the current AR signs a declaration and hands over the distribution and complaint records, and MDA charges RM500 per registration. No new registration or conformity assessment is needed. We plan the hand-over so nothing lapses in between.
How do you handle MDA queries?
They are part of the job, not an extra. On our last 39 new registrations MDA sent a “Require change” request on 34 of them at least once before approving; answering those quickly and completely is most of what separates a 53-day median from a six-month wait. Queries on applications we prepared are handled inside the quoted fee.
Will you tell us when MDA changes the rules?
Yes. We read MDA’s announcements, guidance document list and circular letters, and tell you only what affects your licences and devices, with the date it takes effect. Recent examples: licence fees for 2026 due by 14 December 2026, the import permit moved to 1 July 2027, and the draft Second Edition of the Distribution Records guidance open for comment until 18 November 2026.
Do you keep our product and customer information confidential?
Yes. We never publish client names, products or registration numbers, including in our own track record, which is reported only as counts and medians.
Hand us the calendar
Send the list of what you hold. We tell you what is due, what it costs and what we would take over, in writing.