Quality assurance forum
On application of the MDD 93/42/CE, Medical Devices can circulate freely within the European Community.
To export Medical Devices out of Europe, it is essential that the goods are conform to the local requirements as specified by local competent Authorities.
Each nation has its own PROCEDURES for product evaluation and for the compliancy requirements for each specific type of Medical Device.
The fulfilment of these requirements is necessary to ensure that products put onto the local markets are safe, reliable and high quality. There is no set of rules which can be considered universally compliant worldwide.
Sometimes it is necessary to have a Quality System that is compliant to the rules of the country of destination, others may require specific tests in order to ensure product compliancy with the national laws in that country, other countries have their own specifications regarding the correct product labelling.
In any case the local Authorities carry out the following tests:
- Previous to market introduction (pre-market verification) => project and development tests for the product, production processes, packaging and labelling;
- During sales (placing-on-the market) => distribution network, sales format, advertising;
- After sales (post-market surveillance) => client feedback, accidents /near accident surveillance.
The correct international registration is a “Safe passage”, which permits the legitimate distribution and sale of the product in the territory.
It requires both time and resources, but with constant hard work and respect for all the local laws and requirements, Spencer Italia S.r.l. has already completed the registration of many devices throughout the world.
This is a list of certificates issued by the local International Competent Authorities following International product registration.
- P. REP. of CHINA (SFDA) – SELF LOADING AND HOSPITAL STRETCHERS
- P. REP. of CHINA (SFDA) – STAIR CHAIRS AND EVACUATION CHAIRS
- P. REP. of CHINA (SFDA) – SPINE BOARDS AND VACUUM MATTRESSES
- URUGUAY – HEAD IMMOBILIZER
- RUSSIA – GOST nr. 0496694
- RUSSIA – GOST
- RUSSIA – STRETCHERS AND PATIENT CHAIRS
- RUSSIA – OTHER DEVICES pag. 1
- RUSSIA – OTHER DEVICES pag. 2
- CROATIA – CARRERA PRO pag. 1
- CROATIA – CARRERA PRO pag. 2
- CROATIA –420 CHAIR pag. 1
- CROATA –420 CHAIR pag. 2
The detailed lists of the products included on these certificates along with the registration carried out but for which the Competent Authorities do not issue any specific certificate can be found in the area PRODUCTS.
If the code or the type of product you are interested in is not present in this list, you can request information by sending an email to firstname.lastname@example.org.