- The Director-General of Pharmaceutical and Medical Devices has issued Circular No. HK.02.02/E/1721/2023 on the Post-Market Testing ("Testing") of Medical Devices, which has been in force since 20 September 2023 and which should be complied with by holders of circulation permits for: 1) Medical devices; and 2) Diagnostic in-vitro medical devices (collectively referred to as "Permit Holders").
- Permit Holders are encouraged to complete the independent Testing of all circulated products (produk di peredaran) in order to ensure that said products still fulfill the relevant safety, quality and benefits requirements. A total of six product categories have been designated for Testing, including: 1) Prenatal ultrasound (USG), continuous ventilators, infusion pumps and syringe pumps; 2) Disposable syringes, IV cannulas, catheters, wing needles, fistula needles and infusion sets with needles; and 3) IVD for RDT HIV, syphilis, hepatitis and dengue. The Testing methods that should be applied differ and have been stipulated in accordance with the relevant types of medical devices and products, as listed under Appendix II to the Circular.
- Testing should be completed at least once every two years through accredited testing laboratories in line with the following overall mechanism: 1) Taking of samples; 2) Delivery of samples; 3) Sample testing; 4) Reporting; and 5) Follow-ups. Details of this mechanism are illustrated under Appendices III - IV to the Circular.
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