Malaysia–China reliance, as MDA published it.

Where things stand on 8 October 2026.

Both Malaysia–China pilots have closed. Phase 1, the Malaysia–China Medical Device Regulatory Reliance Programme, ran from 30 July to 30 September 2025 and covered IVDs only. Phase 2, the Malaysia–China Joint Evaluation Pilot Programme, ran from 1 July to 30 September 2026. MDA has not announced a further phase. NMPA is not one of the recognised regulators for MDA’s ordinary verification route (MDA/GD/0070, Annex 1), so a device whose only approval is Chinese goes through full conformity assessment by a registered conformity assessment body. If the same device also holds a recognised approval, such as an EU notified-body certificate or FDA 510(k), it can use the verification route on that approval instead.

How the programme developed

Phase 1 (2025): reliance for IVDs

MDA described Phase 1 as the first reciprocal regulatory arrangement of its kind, under the Global Harmonization Working Party (GHWP) framework. Both authorities agreed to recognise each other’s regulatory decisions for in vitro diagnostic (IVD) medical devices. The press release said Chinese IVDs could use Malaysia’s verification pathway and Malaysian IVDs qualified for China’s Green Channel, with approval timelines reduced to 30 and 60 working days respectively.

The Malaysian side of Phase 1 followed MDA’s verification process:

1. The Chinese manufacturer appoints a licensed local authorised representative; the AR must hold a valid MDA establishment licence.
2. The AR emails the pre-market documentation to MDA (cab.registration@mda.gov.my) for eligibility screening.
3. MDA appoints a CAB with the relevant technical code to carry out the verification assessment under MDA/GD/0068.
4. The CAB issues its certificate and report.
5. The AR applies for registration through MeDC@St, following MDA/GD/0070.
6. MDA evaluates the application and issues the registration certificate; the device is listed on the Medical Device Register (MDAR) for 5 years.

Phase 2 (2026): joint evaluation

Phase 2 ran under the GHWP Common Evaluation Reliance Practice (CERP) framework. Instead of relying on an existing approval, MDA and NMPA assess the same device collaboratively and at the same time, so it was aimed at devices not yet registered in either country.

MDA’s Appendix 1 sets out the Malaysian-side process for a local manufacturer: hold a valid MDA establishment licence, send the pre-market documentation to MDA for screening, have the CAB MDA identifies carry out a full conformity assessment under MDA/GD/0031, apply in MeDC@St, and receive a 5-year registration, while submitting to NMPA in parallel. For China-made devices the notice names NMPA as the submission authority and does not set out the Malaysian steps. It publishes no timeline, application limit or priority list for Phase 2.

What MDA asked for in both phases

Only complete applications were processed. The screening package was:

• QMS: ISO 13485, MDSAP, FDA QSR (21 CFR Part 820) or Japan MHLW Ordinance 169.
• Device information: name, intended use, classification, rule and grouping (see our classification and grouping guides).
• CSDT documentation: executive summary, essential principles (EPSP), design verification and validation summary, pre-clinical and software validation studies, clinical performance, labelling, IFU and brochures, risk analysis and manufacturing information. Our CSDT page covers the format.
• Post-market surveillance system information.
• Declaration of Conformity.
• Phase 1 only: the Class II registration certificate from the provincial MPA or the Class III certificate from NMPA.

The routes compared

Every route ends in the same place: a MeDC@St application by a licensed Malaysian establishment and a 5-year registration. Published review times for each route are on our registration timeline page.

What a Chinese manufacturer needs on any route

• A Malaysian authorised representative with a valid MDA establishment licence to hold the registration; see our authorised representative service and the MDA establishment licence guide.
• The Malaysian class and rule for the device. MDA’s notices set Chinese Class II and III beside Malaysian Classes B to D, but the Malaysian class comes from the First Schedule rules, so classify the device under those rules rather than translating the Chinese class.
• A CSDT dossier, a Declaration of Conformity in the Malaysian format and a current QMS certificate.
• Your own facility. Both pilots excluded OEM brand owners, rebranders, relabellers and assemblers, so if a future phase follows the same rules, the legal manufacturer must also be the one making the device.

If you would rather work in Chinese, see our Chinese-language page.

Our reading of the pilots

• The windows were short. Each phase accepted applications for two to three months, and Phase 1 capped applications at six. Plan the Malaysian launch on an open route, and treat a future pilot as a bonus.
• A recognised approval is the practical shortcut today. If the device already holds an EU notified-body certificate, FDA clearance or another approval listed in MDA/GD/0070 Annex 1, the verification route is open now.
• Keep the dossier pilot-ready. The screening package above is the same content a full conformity assessment needs, so the work is not wasted if no further phase opens.