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AA Alive Sdn Bhd · SSM 1204108-DMDA-licensed practiceSuperbrands Malaysia 20251,000+ devices registered
ISO 13485.MY
About · AA Alive Sdn Bhd (1204108-D) · Est. 2016

A quality-system practice that has sat on your side of the counter.

ISO 13485 Malaysia is the quality-management and licensing arm of AA Alive Sdn Bhd — a group that registers, imports and supplies medical devices itself. We advise from experience, not from templates.

The practice

AA Alive Sdn Bhd was founded in 2016 by Evin Lim and has grown into a portfolio spanning medical equipment supply and regulatory consulting. The consulting practice — operating as GDPMD Malaysia at gdpmd.my, as the device flagship medicaldeviceconsultant.my and as this ISO 13485 / QMS practice — has registered 1,000+ medical devices with MDA and guided importers, distributors and manufacturers through GDPMD certification, ISO 13485 implementation and establishment licensing across Malaysia.

What makes the practice unusual is that the group also holds licences and registrations of its own: we operate device supply businesses, so we run the same GDPMD system, keep the same records and face the same audits we build for clients. When we say a procedure is workable at 8pm on a delivery night, it is because ours has to be.

Our founder

Evin Lim is a medical device industry consultant whose commentary on the Malaysian pharmaceutical and device industry has been featured on national media:

  • BERNAMA TV — panelist, Ruang Bicara: Aspirasi Ekonomi on the pharmaceutical and medical device industry (3 July 2026)
  • RTM — quoted in Portal Berita RTM on regulation and medical costs (July 2026)
  • Superbrands Malaysia — CEO Interviews 2025 on the official Superbrands Limited channel (December 2025)

Watch the appearances on our media coverage page.

Credentials & recognition

  • AA Alive Sdn Bhd — registered with SSM Malaysia (1204108-D), operating since 2016
  • MDA establishment licence MDA-6798-K124 — held by the practice; we run the same GDPMD system we build for clients
  • 1,000+ medical devices registered with the Medical Device Authority
  • 98% approval success rate, typically within 3 months
  • Superbrands Malaysia 2025 (Malaysia's Choice) award recipient
  • Founder featured on BERNAMA TV and RTM as a device-industry consultant
  • Serving clients nationwide — remote-friendly engagements

Contact

ISO 13485 Malaysia — HQ / Showroom
Lot 1, Jalan Perusahaan 4, Kawasan Industri Batu Caves, 68100 Batu Caves, Selangor, Malaysia
Phone/WhatsApp: 010-206 2070
Email: contact@evin2u.com

Who you’ll work with

Named people, with profiles you can check.

AA Alive’s device regulatory team on a client visit
AA Alive’s device regulatory team, on client visits across Malaysia.
Founder & Managing Director · Regulatory authority

Evin Lim

Advises from the operator’s chair — the group registers, imports and supplies devices itself — and speaks on the Malaysian pharmaceutical and device industry on BERNAMA TV and RTM.

LinkedIn profile
Commercial Lead · Your first contact

Lim Yen Thong

Your first point of contact for scope, timelines and quotations. Lim Yen Thong runs the commercial side of the device practice and coordinates every engagement from first enquiry to signed proposal.

LinkedIn profile