There are few direct implications to the Customes Agreements for manufacturer of medical devices from Turkey. Read all the details in our article!
Free sales certificate (FSC)
FAMHP releases its Annual Report: Focus on medical devices
The digital Annual Report 2019 contains interesting figures concerning medicines and medical devices read more about it here.
Medical device procurement in Vietnam: How many Free Sales Certificates do you need?
Learn more about the new procedures for medical device procurement in Vietnamese public health facilities and free sales certificate requirements and limits.
Free Sales Certificates needed for medical device registration in Bosnia and Serbia
It is well known that for Medical and In Vitro Diagnostic Devices, the best tool easing the access to non-European markets is the Free Sales Certificate, which allows the manufacturer to prove the compliance of his devices with the EU laws and safety standards. These EU standards are then fully accepted and welcomed as the best possible ones also outside the European Union, typically as an official proof of compliance or generally to clear the Customs.
New Electronical Apostille system from the Belgian Ministry of Foreign affairs
The Belgian Ministry of Foreign Affairs' new electronic apostille system for Free Sales Certificates will have a positive impact on legalization timeframes.
Saudi Arabia – SASO and CAP (Conformity Assessment Program) do not apply to Medical Devices – FSC is the best tool to enter this market
SASO CoC (Certificate of Conformity) and CAP (Conformity Assessment Program) are two particular Conformity Assessment routes that are allowing manufacturers worldwide to enter the market of Saudi Arabia with their products. This is in order to ensure some key objectives such as: Protection of public health, Consumer safety, National security, Protection of religious and public morals and environment, Prevention of deceptive practices.
New countries admitted to the Hague Conference
Dominican Republic, Colombia, Kazakhstan and Lebanon have been added to the Hague Conference on Private International law taking place in June 2017.
The new South African Health Products Regulatory Authority (SAHPRA)
The South African government has formed an independent, state-owned agency, SAPHRA, to oversee medical device and pharmaceutical regulatory systems.
Obelis at Medica 2016
Obelis Group exhibited for the 13th consecutive year at Medica Trade Fair, one of the…
Obelis to hold EROMED seminar at MEDICA 2016
Obelis Group will hold an EROMED seminar at the MEDICA trade show, taking place from the 14th November till 17th November in Messe Düsseldorf, in Germany. The seminar, which is entirely free of charge, will be conducted at the Obelis booth (Hall 17, Stand D59), every day at 11 am and 3 pm. It will focus on the new proposal on EU legislation on Medical Devices and its impact on the compliance path and the CE marking process.