Towards common ASEAN medical device regulations
BANDAR SERI BEGAWAN
THE Ministry of Health (MoH) called on members of the local medical device industry to support Brunei’s efforts towards implementing the ASEAN Medical Device Directive (AMDD).
Permanent Secretary Datin Paduka Dr Hjh Norlila Dato Paduka Hj Abdul Jalil yesterday called for cooperation from major stakeholders as the country prepares to finish drafting its act and regulations as part of its obligation on the directive.
She advised them to participate in more medical device regulation events and start learning from their ASEAN counterparts on the placement of medical devices in the market.
During the 19th ASEAN Consultative Committee on Standards and Quality – Medical Device Product Working Group (ACCSQ-MDPWG) Meeting, she told industry members to acquire the required tools and knowledge to ensure minimal delays in placing their medical devices in Brunei.
Datin Paduka Dr Hjh Norlila reiterated that the Sultanate will remain a supporter of a common medical device regulation for the region.
“And we are putting every effort into transposing the AMDD into (our) national law and will keep continuing to support ASEAN initiatives, especially on medical devices,” she told delegates at the Rizqun International Hotel.
She said the Healthcare Technology Department at MoH has been tasked to look into medical device regulatory matters.
The department has taken the initiative to form a Medical Device Regulatory Unit under its Biomedical Engineering Section in 2011 with the primary task of initiating the development process of medical device regulation in Brunei.
In November 2013, the unit was further upgraded with the sole purpose of developing the regulation of medical devices in the nation.
The Permanent Secretary said Brunei has also been actively preparing its staff for the development process as well as developing medical device regulation mechanisms through various capacity building activities.
They have also conducted post-market surveillance on medical devices in the country through administration control.
Surveillance was also carried out through discussions on matters concerning medical device regulation with local and foreign stakeholders such as the Conformity Assessment Body, consultants and manufacturers.
The Healthcare Technology Department has also developed proposals for development of acts and regulations through research and comparison of acts regulations.
They have also undertaken research on the guidance documents of relevant countries in the region: Global Harmonisation Task Force and its members the US, Canada, EU, Australia and Japan; World Health Organisation; and International Standards Organisation.
As part of its proposed medical device regulation, Brunei has also adopted important documents developed by ACCSQ-MDPG.
Among the documents adopted by the Sultanate are the ASEAN Common Submission Dossier Template (ACSDT) and its guidance document, ASEAN Adverse Event Form and ASEAN Field Safety Corrective Action (FSCA) Form.
Datin Paduka Dr Hjh Norlila explained the ACSDT will be used as part of the requirements for medical device registrations in the country.
The Brunei Times