Free Sale Certificate and Apostille Pack for Medical Device Exports
Quick answer: A free sale certificate proves that a device may be sold freely in the country of manufacture, and an apostille...
Read ArticleCE, ISO 13485, FDA, MDR, IEC 60601, RoHS, REACH, UDI, Free Sale, Apostille, and vigilance reporting for medical equipment.
Quick answer: A free sale certificate proves that a device may be sold freely in the country of manufacture, and an apostille...
Read Article
The EU MDR transition has set a phased deadline that runs past 2027, which means a device placed on the EU market...
Read Article
The UAE operates a two-track system for medical device oversight: a federal track under the Ministry of Health and Prevention (MOHAP) that...
Read Article
Tanzania is one of East Africa’s most active medical device import markets, and its regulator — the Tanzania Medicines and Medical Devices...
Read Article
Nigeria NAFDAC Requirements for Medical Devices Nigeria is the largest medical device market in West Africa by population, and every imported device...
Read Article
Certificate Package for African Tenders: CE, ISO, Legalisation and Apostille On paper, an equipment tender is won on price. In practice, a...
Read Article
Kenya Medical Device Registration: Pharmacy and Poisons Board If you want to sell a medical device in Kenya, you need to register...
Read Article
Post-Market Surveillance Plans for Distributors Post-market surveillance is not a compliance box; it is the ongoing process of watching a device in...
Read Article
The price of a surgical light or operating table from China is rarely the most expensive part of the deal. The cost...
Read Article
Labeling and Instructions for Use: MDR Basics for Medical Devices In the European Union, a medical device is not legal to place...
Read Article