25 May 2018: AMMI Regulatory Affairs Meeting and Dialogue with Medical Device Authority

25 June 2018: AMMI Regulatory Affairs Meeting and Dialogue with Medical Device Authority

The meeting was held at the new MDA headquarters at Cyberjaya and was attended by 55 AMMI members. MDA was represented by CEO, Encik Zamane and top MDA officials. AMMI presented its policy advocacy on key regulatory issues related to Change Notification for Registered Medical
Device (MDA/GD/0020), Notification of Medical Device Intended for Transit and Registration of Drug-medical Device and Medical Device-drug Combinations Products
Key takeaways:
1. Contract Manufacturers are not subject to the Reminder Notice dated 21 May 2018 on Full Enforcement on Registration Requirement for Medical Devices by 30 June 2018.
2. Export-only devices which do not require Certificate of Free Sales (CFS) are exempted from medical device registration.
3. MDA agreed in principle to remove the labelling requirement for export-only devices (subject to approval from MDA’s Board).
4. Medical device 100% in transit only (“passing the gate”) may be exempted from MDA’s control.
5. Five (5) years’ exemption for entire labelling compliance (not just for medical device registration only.