Arazy Group Resources
Regulatory information and product registration know-how to help you manage your global market access
Registered by Arazy Group’s 
LICENSALE®2.0
IDM100 Medical Tablet,
Canada
Canada
Densah Burs & Tapered Pilot Drill and Universal Bur Holder & Parallel Pins,
Moldova
Moldova
Cardiovit AT-102 G2,
USA
USA
Chemdye,
USA
USA
Bionova,
USA
USA
SENSA with measuring function,
Saudi Arabia
Saudi Arabia
Multichem S, S+, NB, HsTn and WBT,
Australia
Australia
PR of Sleepsafe Porter,
Saudi Arabia
Saudi Arabia
The AIO Solution,
USA
USA
Class III Huber Needles,
Brazil
Brazil
OraQuick HIV Test,
Rwanda
Rwanda
CB9 strips for the Clearblue Digital Pregnancy Test with Conception Indicator,
Philippines
Philippines
CB9 strips for the Clearblue Digital Pregnancy Test with Conception Indicator,
Korea
Korea
OraQuick HIV Test,
Ukraine
Ukraine
HemoTypeSC,
Kenya & Nigeria
Kenya & Nigeria
Recently Added
Medical Device Registration and Supply in Ukraine
According to the Medical Device Rules 2017, “A medical device that is essential to or that yields information that is essential to the restoration or continuation of a body function important to the continuation of human or animal life” are exempted from either Establishment Certificate and/or Enlistment/Registration Certificate.
Mundomedis and Arazy Group Sign Cooperation MoU
Mundomedis FZCO and Arazy Group recently signed a cooperation memorandum. Both companies will cooperate to support Mundomedis’ global medical device portfolio companies by streamlining their global regulatory processes through Arazy Group’s Licensale online platform.
Certain Medical Devices in India will be Considered as Drugs as of 30 June 2022
A February 8, 2019 announcement by the Ministry of Health & Family Welfare, Government of India declaired that certain health devices were to be regulated as drugs, effective April 1, 2021. That deadline has been extended.
Medical Devices Registration Exemption in Pakistan
According to the Medical Device Rules 2017, “A medical device that is essential to or that yields information that is essential to the restoration or continuation of a body function important to the continuation of human or animal life” are exempted from either Establishment Certificate and/or Enlistment/Registration Certificate.
Mandatory Registration Scheme for Non-Notified Medical Device in India
According to the Medical Device (Amendment) Rules – February 2020 (1), which was enforced in April 2020, all non-notified medical devices can be voluntarily registered with the Central Licensing Authority (CLA) through the online system for medical devices.
Regulatory News Articles
Regulatory Update Videos (Country Specific)
