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Medical Device Registry Insights · FDA

Myanmar Medical Device Registry Statistics

Aggregated from 4,664 official FDA registration records covering 1,595 manufacturers from 38 countries. Data as of 2022-12-21.

4,664
Registrations
1,595
Manufacturer names
283
Authorized Representative names
38
Manufacturer countries
DJ Fang
DJ Fang
MedTech Regulatory Expert

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New registrations by year
20212022
VerifiedFDA · data as of 2022-12-21

Published Manufacturer Countries

Countries associated with manufacturers in this dataset (top 15); these do not establish individual manufacturing-site locations.

#CountryRegistrationsShare
1China1,36729.3%
2United States57312.3%
3Germany51711.1%
4India4199.0%
5South Korea3868.3%
6Japan2465.3%
7United Kingdom1573.4%
8France1092.3%
9Taiwan891.9%
10Malaysia731.6%
11Ireland711.5%
12Mexico671.4%
13Italy631.4%
14Switzerland621.3%
15Thailand571.2%

Top 50 Manufacturers in Myanmar

Ranked by registrations under published names. Name grouping does not establish legal-entity identity or corporate relationships.

RankManufacturerPublished countryRegistrations
#1
Roche Diagnostics GmbHGermany166
#2
Boditech Med IncSouth Korea107
#3
SD Biosensor, Inc.South Korea75
#4
Guangzhou Wondfo Biotech Co., Ltd.China67
#5
Shenzhen New Industries Biomedical Engineering Co., Ltd.China66
#6
KARL STORZ SE & Co. KGGermany42
#7
Roche Molecular Systems, Inc.United States33
#8
Shenzhen Mindray Bio Medical Electronics Co., LtdChina32
#9
Prevest DenPro LimitedIndia31
#10
Randox Laboratories Ltd.United Kingdom30
#11
Shijiazhuang Hipro Biotechnology Co.,ltdChina30
#12
Changzhou Kanghui Medical Innovation Co., LtdChina26
#13
CovidienDominican Republic25
#14
Zybio Inc.China24
#15
Aesculap AGGermany23
#16
Jarit GmbHGermany23
#17
Erbe Elektromedizin GmbHGermany20
#18
WUHAN MINDRAY SCIENTIFIC CO.LTD.China20
#19
Aomori Olympus Co., LtdJapan19
#20
Abbott Ireland Diagnostics DivisionIreland18
#21
Abbott VascularUnited States18
#22
CTK Biotech, Inc.United States18
#23
Sansure Biotech Inc.China18
#24
Advance Healthcare Ltd.United Kingdom17
#25
Gesellschaft für Biochemica und Diagnostica mbHGermany17
#26
Hangzhou Biotest Biotech Co., Ltd.China17
#27
InTec PRODUCTS, INC.China17
#28
Abbott Diagnostics Korea Inc.South Korea16
#29
Flexicare Medical (Dongguan) Ltd.China16
#30
Nantong Diagnos Biotechnology Co., LtdChina16
#31
Shirakawa Olympus Co.,LtdJapan16
#32
Siemens Healthcare Diagnostics IncUnited States16
#33
Xinhua Surgical Instruments Co. LtdChina16
#34
ASAHI INTECC (THAILAND) CO.,LTDThailand15
#35
Bistos Co., Ltd.South Korea15
#36
Boston Scientific CorporationCosta Rica15
#37
Dentium Co., LtdSouth Korea15
#38
Nihon Kohden Tomioka Corporation Tomioka Production CenterJapan15
#39
Ortho-Clinical Diagnostic.,United Kingdom15
#40
Wellmed International Industries Pvt. LtdIndia15
#41
Coral Clinical Systems - A Division of Tulip Diagnostics (P) Ltd.India14
#42
Qingdao Hightop Biotech Co.,LtdChina14
#43
TaiDoc Technology CorporationTaiwan14
#44
Fisher DiagnosticsUnited States13
#45
Jeil Medical CorporationSouth Korea13
#46
Romsons International (Unit-II)India13
#47
Tianjin Zhengtian Medical Instrument Co., Ltd.China13
#48
Viant Medical, IncUnited States13
#49
Edan Instruments, Inc.China12
#50
Sirona Dental Systems GmbHGermany12

Top 50 Authorized Representatives in Myanmar

Published authorized representative names ranked by registrations held.

RankAuthorized RepresentativeRegistrationsManufacturers represented
#1
SEA LION COMPANY LIMITED506220
#2
YEE SHIN COMPANY LIMITED326103
#3
OKKAR THIRI COMPANY LIMITED27291
#4
A A MEDICAL PRODUCTS LIMITED27127
#5
BIOMED MYANMAR COMPANY LIMITED20117
#6
ZIZAWA COMPANY LIMITED18256
#7
ZEYA & ASSOCIATES COMPANY LIMITED12551
#8
HEALTHCARE MANDALAR PHARMACEUTICALS AND LABORATORY COMPANY LIMITED11911
#9
EVER GLORY COMPANY LIMITED11852
#10
ADVAMED MEDICAL INNOVATION COMPANY LIMITED11542
#11
DKSH (MYANMAR) LIMITED9444
#12
CONCORDIA INTERNATIONAL COMPANY LIMITED8326
#13
ADVANCED MEDICAL & DIAGNOSTICS TRADING LIMITED6137
#14
BIZ-PARTNER GROUP COMPANY LIMITED5936
#15
SHWIN CHAN TRADING COMPANY LIMITED585
#16
U THAN OHN & SONS COMPANY LIMITED5718
#17
HOLY FLYING TIGER HERITAGE COMPANY LIMITED5520
#18
NI LAY NAING COMPANY LIMITED5017
#19
DENTAL KEY DENTAL TRADING LIMITED467
#20
AMTT CO., LTD4516
#21
GLORIOUS LIGHT TRADING COMPANY LIMITED4214
#22
ZWT PHARMA COMPANY LIMITED4121
#23
MYANMAR ZIRCON COMPANY LIMITED3813
#24
VITAL DIAGNOSTICS COMPANY LIMITED382
#25
SNOW EVEREST COMPANY LIMITED3520
#26
MIRACLE LIGHT COMPANY LIMITED3214
#27
FOCUS HEALTH COMPANY LIMITED315
#28
GOLD LITE MYANMAR COMPANY LIMITED3115
#29
THUKA KALYAR COMPANY LIMITED3112
#30
MEKONG GLORY MEDICAL COMPANY LIMITED3011
#31
SIRIUS LOGISTICS & DISTRIBUTION SOLUTIONS COMPANY LIMITED283
#32
MYITTAR BIOTECH COMPANY LIMITED289
#33
J D S CO., LTD.2613
#34
TAW WIN YONG NI OO COMPANY LIMITED254
#35
DEW MEDICAL AND DIAGNOSTIC (DMD) COMPANY LIMITED247
#36
GRAND MEDI CORE COMPANY LIMITED238
#37
ABMT MYANMAR COMPANY LIMITED2111
#38
NOVEL LIFE COMPANY LIMITED214
#39
GAMBIRO CO., LTD208
#40
PASSIONCARE COMPANY LIMITED208
#41
HEALTH GLORY COMPANY LIMITED205
#42
C.I.L COMPANY LIMITED1910
#43
MYANMAR AMERICAN VISION COMPANY LIMITED1813
#44
KYMS TRADING COMPANY LIMITED188
#45
POLE STAR PALACE COMPANY LIMITED174
#46
PEAK GLOWIC COMPANY LIMITED179
#47
MEDITECH COMPANY LIMITED1711
#48
THE SUN COMPANY LIMITED176
#49
DISTINCT MEDICAL COMPANY LIMITED169
#50
UNIQUE POWER TOOL COMPANY LIMITED1610
About the data

What the FDA medical device registry shows

The Myanmar Food and Drug Administration (FDA) regulates medical devices in Myanmar. As of 2022-12-21, this official dataset snapshot contains 4,664 registration records. The most frequently listed manufacturer name is Roche Diagnostics GmbH with 166 registrations. China is the most represented manufacturer country, accounting for 1,367 registrations (29.3%). The dataset lists 283 distinct published authorized representative names.

Every figure is computed from the official dataset snapshot as mirrored in the Pure Global database. Published company names are grouped by whitespace and case. These name counts do not establish distinct legal entities or corporate relationships. Product and category labels use the derived English value when the current row has one and otherwise preserve the official source-language value. Browse individual records in the searchable Myanmar device database, or see our methodology for how the data is collected.

VerifiedMyanmar Food and Drug Administration · 4,664 records · generated 2026-08-26
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