Specify advanced management medical equipment, such as manufacturing and sales certification services
Manufacture and sale of certification services
2014 November 25, from "Pharmaceuticals, quality such as medical devices, Law for ensuring the effectiveness and safety" (Pharmaceuticals and Medical Devices Act) was enacted amendment.
Certification of medical equipment, but I've just been introduced by the enforcement has been revised Pharmaceutical Affairs Law in April 2005, specify advanced management medical equipment Health, Labor and Welfare designated by the Minister establishes standards even in the Pharmaceuticals and Medical Devices Act, etc. is the manufacture and sale of skill in the art, it has been stipulated that must be certified by a registered certification body for each individual item prior to the market. (Pharmaceuticals and Medical Devices Act Article 23 2 of 23 the first term of)
received from us April 1, 2005, the registration of as authority from the Ministry of Health, Labor and Welfare (registration number: No. AG), specify advanced management medical we made the offer of the manufacture and sale authentication service of equipment and the like.
In our company, and all of the designated controlled medical devices, is possible authentication for the specified advanced management medical equipment below.
Designated controlled medical devices (class Ⅱ)
- active implantable devices
, anesthesia, respiratory equipment
and dental equipment
, electronic medical equipment
and facilities for equipment
and non-active implantable devices
, ophthalmology and visual equipment
and re-usable equipment
, single -use equipment
, household massager, household electrotherapeutic device and its associated equipment
, hearing aids
, radiation and imaging equipment
It specifies highly controlled medical devices (Class Ⅲ)
- Insulin pen injector
, enteral nutrition for infusion pumps, general purpose infusion pumps, syringe infusion pump and infusion pump for patient-controlled analgesia
Quote form for the specified advanced management medical equipment, such as manufacturing and sales certification application business