| 000 -LEADER |
|---|
| fixed length control field |
a |
| 003 - CONTROL NUMBER IDENTIFIER |
|---|
| control field |
OSt |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
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| control field |
20220101152620.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
220101b xxu||||| |||| 00| 0 eng d |
| 040 ## - CATALOGING SOURCE |
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| Original cataloging agency |
AIKTC-KRRC |
| Transcribing agency |
AIKTC-KRRC |
| 100 ## - MAIN ENTRY--PERSONAL NAME |
|---|
| 9 (RLIN) |
7683 |
| Author |
Kalaiselvan, Vivekanandan |
| 245 ## - TITLE STATEMENT |
|---|
| Title |
Medical device’s regulation in South-East Asian countries: Current status and gap areas |
| 250 ## - EDITION STATEMENT |
|---|
| Volume, Issue number |
Vol.11(3), July-Sep |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
|---|
| Place of publication, distribution, etc. |
Raipur |
| Name of publisher, distributor, etc. |
Asian Pharma Press |
| Year |
2021 |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Pagination |
173-179p. |
| 520 ## - SUMMARY, ETC. |
|---|
| Summary, etc. |
As 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 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| 9 (RLIN) |
4639 |
| Topical term or geographic name entry element |
PHARMACEUTICS |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
|---|
| 9 (RLIN) |
15324 |
| Co-Author |
Aishwarya, G. |
| 773 0# - HOST ITEM ENTRY |
|---|
| International Standard Serial Number |
2231-5683 |
| Title |
Asian journal of pharmaceutical research |
| Place, publisher, and date of publication |
Raipur Asian Pharma Press |
| 856 ## - ELECTRONIC LOCATION AND ACCESS |
|---|
| URL |
https://asianjpr.com/AbstractView.aspx?PID=2021-11-3-6 |
| Link text |
Click here |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Source of classification or shelving scheme |
|
| Koha item type |
Articles Abstract Database |
