| Hakim Hayat |
ASEAN member countries are urged to adopt a standardised set of regulations on medical device, following the recent signing of the Asean Medical Device Directive (AMDD) by the bloc’s economic ministers recently.
Permanent Secretary at the Ministry of Health (MoH) Datin Paduka Dr Hajah Norlila binti Dato Paduka Haji Abd Jalil made this call yesterday at the opening of the three-day ‘19th Asean Consultative Committee on Standards and Quality Medical Device Product Working Group (MDPWG) and its Related Events’ meeting held at Rizqun International Hotel.
Brunei will remain a strong supporter of the effort within Asean, she said, before going on to share some of the Sultanate’s initiatives to regulate medical devices.
The Healthcare Technology Department (HTD) of the Ministry of Health, tasked with looking into medical device regulatory matters, took the initiative to form a Medical Device Regulatory Unit under its Biomedical Engineering Section in 2011. Since last year, it has been upgraded through actively preparing its staff for the development process as well as developing medical device regulation mechanisms through various capacity building activities, carrying out post-market surveillance on medical devices in Brunei through administrative control as well as actively approaching and discussing with stakeholders inside and outside of Brunei.
To realise the objective of adopting such law in the Sultanate, she urged strong cooperation from major stakeholders or local medical device industry members by supporting and participating, as well as encouraging them to learn from other Asean medical device industry members.
Datin Paduka Dr Hajah Norlila said local medical device industry members should start equipping their business with the required tools and knowledge “to ensure the minimisation of delays in placing medical devices into the country.”
According to a MoH press release, the MDPWG is part of a working group under the Asean Consultative Committee on Standards and Quality (ACCSQ) that is tasked to coordinate technical needs for medical device regulation in the region.
Apart from discussing matters on medical device regulation in the region, some of the working group’s other agenda are discussion on capacity building programmes with regional and international partner organisations, and development status of regional and international bodies involved in medical device regulation and planning ahead on the working group’s agenda for the next meeting.
Over 160 delegates comprising officials from the Asean Secretariat, regulators, authorities from Asean member countries and members of the medical device industries in the region are attending the meeting.