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Mission
THEMA offers strategic and regulatory consulting to medical device IVDs and regulatory-related companies.
THEMA aims to help the Customer to achieve his own commercial purposes, using a reliable and competent regulatory specialist partner.
THEMA supports national and foreign companies with needs, projects, possibilities and different aims that want to place their devices on national and international markets in compliance with regulations.
Our team has the required professional skills and competencies to perfectly understand Customer’s needs, products and services, by acting quickly and in the most suitable manner.
Our branches and international partners collaborate with us to find out the solution that best suits Customer’s specific needs, protecting even his interests.
Mission
FAQ
What is a regulatory strategy
How do I register medical devices in the world
Why is the CE marking required
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Countries
Countries
News
- 19 June 2020 Because of the postponement by one year of the date of implementation of the MDR (EU) 2017/745 Medical Devices Regulation (May 26, 2021), the European Commission published a new implementing ...
- 19 June 2020 In France, on January 21, 2020, the Ministry of Solidarity and Health and the Ministry of Action and Public Accounts have issued a decree according to which, from January 1, ...
- 19 June 2020 From April 1, 2020 Health Canada has updated licensing fees and the registration of medicines and medical devices according to the consumer price index. It consists of a significant increase ...
- 27 May 2020 In accordance with the FDA guideline “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking” for class I medical devices and Unclassified devices, deadlines ...
- 27 May 2020 Due to the Covid-19 medical emergency, the Indonesian Ministry of Health has simplified the procedures in order to facilitate the import of medical equipments. Simplified COVID-19 import procedures Previously, imports of medical ...
- 27 May 2020 The Medical Device Coordination Group (MDCG) has recently published several interesting guidelines for the medical and in vitro diagnostic medical devices fields. New guidelines published by MDCG The MDCG 2020-5 “Clinical Evaluation – Equivalence. ...
- 20 April 2020 To face the COVID-19 epidemic effects, FDA has published the “Post marketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic” guideline concerning adverse event management during ...
- 20 April 2020 Because of COVID-19 pandemic, last March 30, 2020 the Canadian Minister of Health, Patty Hajdu, signed a provisional order allowing extraordinary regulatory exceptions to importation and selling of specific medical healthcare products in ...
- 20 April 2020 Recently ANVISA has published two regulations RDC 340/2020 and IN 61/2020, introducing from April 1, 2020 new classification rules for medical device changes. The changes to the device have been classified in ...
- 27 March 2020 The Medical Device Coordination Group (MDCG) approved the guideline on significant changes required by article 120 of the MDR concerning the Period of Grace MDD or AIMDD certificates. MDCG guideline ...