000			a
999			_c15887 _d15887
003			OSt
005			20220101152620.0
008			220101b xxu||||| |||| 00| 0 eng d
040			_aAIKTC-KRRC _cAIKTC-KRRC
100			_97683 _a Kalaiselvan, Vivekanandan
245			_aMedical device’s regulation in South-East Asian countries: Current status and gap areas
250			_aVol.11(3), July-Sep
260			_aRaipur _bAsian Pharma Press _c2021
300			_a173-179p.
520			_aAs Medical device application in disease prevention, diagnosis or treatment is evolving to a greater extent; there is a need for regulation to monitor its quality, safety and efficacy. The present article attempts to study the medical device regulation available in eleven South-East Asian World Health Organization (WHO) member countries. The information searched from the available sources reveals that medical device regulation exists in seven countries. Most of the countries follow the International Organization for Standardization (ISO) 13485 for their quality standards in medical devices. Most countries also specified the time frame and authority to which adverse event is to be reported. Countries like India and Thailand have separate Adverse Event reporting forms for the medical device. The present study reveals that there is no separate web-based database for adverse event reporting of medical devices. Therefore, WHO South-East Asian Regulators Network (SEARN) under South East Regulatory Office (SERO) office may provide handholding support to these regions in developing a common software or tool for the management and analysis of signals arising from the adverse events.
650		0	_94639 _aPHARMACEUTICS
700			_915324 _aAishwarya, G.
773	0		_x2231-5683 _tAsian journal of pharmaceutical research _dRaipur Asian Pharma Press
856			_uhttps://asianjpr.com/AbstractView.aspx?PID=2021-11-3-6 _yClick here
942			_2ddc _cAR