For class II medical device registration certificate to charge testing fees.
Ningbo second and third class medical device registration fee:
In our country medical devices in accordance with the risk level classification of Class I medical devices, Class II medical devices and Class III medical devices, for different management categories of medical devices, the path to marketing authorization and marketing authorization approval unit level is different, the first class of medical devices to the municipal market supervision and administration bureau The first class medical devices are approved by the municipal market supervision bureau, the second class medical devices are registered by the provincial/municipal drug administration for approval, and the third class medical devices are approved by the State Drug Administration.
The charges for registration of various types of medical devices are also different, at present, there is no charge for the filing of the production of Class I medical devices in Zhejiang Province, the charge for the registration of Class II medical devices is 65,730 yuan, and the charge for the registration of Class III medical devices is 153,600 yuan.
Companies want to apply for Class II medical device filing:
First of all, look at the company's scope of business there is no Class II medical device sales; if not, to change the company's scope of business, the new license out, and then apply for Class II medical device filing; Class II medical device filing requires personnel: an enterprise at least one enterprise responsible person and the person in charge of quality: the person in charge of the enterprise can be the Legal person can also be the company's employees, there is no educational requirements; required to provide a copy of ID card. Contact phone number, email. The last year's physical examination report (including laboratory tests), serving in the unit's social security statement, resume.
The person in charge of quality is required to be a relevant professional (relevant professional refers to medical devices, biomedical engineering, machinery, electronics, medicine, bio-engineering, chemistry, pharmacy, nursing, rehabilitation, testing, computers, law, management, etc.), at least college degree; provide a copy of the ID card, copy of the certificate of academic qualifications or proof of title, resume form of the personnel, proof of employment in the unit (social security statement) ,Physical examination report (within the last year).