Perlong medical device network information: in order to promote the management of the local medical device market，Sichuan Province Food and Drug Administration issued new regulations on the management of medical equipments.
Pointed out that the new medical device regulations, the sale of the
sale of medical equipment must have a real estate license to be
eligible. By the common people's dissatisfaction. This reporter a
special visit to the Food and Drug Administration leaders said many
businesses did not fully understand the new requirements, "must have a
real estate license requirement only for the business scope containing
Class III implant materials and artificial organs, interventional
equipment, medical equipment, electronics equipment class high-risk
small number of enterprises. "
Thermometer wheelchair can still be sold as usual
We are commonly used in thermometers, sphygmomanometers belong to Class II medical devices, while many people to the elderly to buy wheelchairs, but also belong to a class II medical devices. Not meet the new standards may only choose to close the switch to. Previously, operating medical devices in the General Street Anke learned that he amounted to less than new regulations, and other businesses, was very anxious helplessness.
However, the Sichuan Provincial Food and Drug Administration yesterday to the West China City Daily Reporter, people's daily lives of a large thermometer, blood pressure monitors can be as usual to sell. According to reports, the State Food and Drug Administration on May 26, 2005 and November 3, 2011, released two batches do not need to apply for "Medical Device Distribution Enterprise License" Class II medical devices directory. Have thermometers, wheelchairs and other 19 common species included in this directory.
Therefore, the Provincial Food and Drug Administration on the operation of the above varieties of medical equipment businesses were not doing the licensing requirements, as only business class II medical device products in the directory, you do not need to apply for "Medical Device Distribution Enterprise License.
Its own real estate license only for a small number of enterprises
Housing ownership certificates "must have" this provision, in the end for the operation of the medical equipment business? Province Food and Drug Administration, this made it clear that this provision only for the business scope contains Class III implant materials and artificial organs, intervention equipment, medical electronic equipment class high-risk minority enterprises, and the class risk medical device products is for informational purposes only and medical institutions, professional physicians healed the sick.
Province Food and Drug Administration also said that the new introduction of the "Sichuan Medical Device Distribution Enterprise License inspection and acceptance criteria, the main principles of the masses of the people with armed security, effective, convenient, controllable risk, start-up business The small number of high-risk Class III medical devices varieties bid conditions.
Sichuan Province Food and Drug Administration official told reporters, "such as medical devices like pacemakers, once a problem, the tenants of housing ownership certificates relative tenants of housing ownership certificates, after the traceability will be better to do. "
Premises is not non-shops can not
Provincial Food and Drug Administration yesterday also revised standards further interpretation. Provincial Food and Drug Administration pointed out that the declaration of the "Medical Device Distribution Enterprise License enterprises in the province, does not necessarily require to shops, business premises, commercial office buildings, office buildings can be used as business premises.
“Cherish Your Life and Care About Your Health” is always the principle of our company. As a professional manufacturer of medical products, we will spare no effort to make great contributions to the development and improvement of medical industry.Choose perlong medical, you won't regret it, thank you for your visiting!
Thermometer wheelchair can still be sold as usual
We are commonly used in thermometers, sphygmomanometers belong to Class II medical devices, while many people to the elderly to buy wheelchairs, but also belong to a class II medical devices. Not meet the new standards may only choose to close the switch to. Previously, operating medical devices in the General Street Anke learned that he amounted to less than new regulations, and other businesses, was very anxious helplessness.
However, the Sichuan Provincial Food and Drug Administration yesterday to the West China City Daily Reporter, people's daily lives of a large thermometer, blood pressure monitors can be as usual to sell. According to reports, the State Food and Drug Administration on May 26, 2005 and November 3, 2011, released two batches do not need to apply for "Medical Device Distribution Enterprise License" Class II medical devices directory. Have thermometers, wheelchairs and other 19 common species included in this directory.
Therefore, the Provincial Food and Drug Administration on the operation of the above varieties of medical equipment businesses were not doing the licensing requirements, as only business class II medical device products in the directory, you do not need to apply for "Medical Device Distribution Enterprise License.
Its own real estate license only for a small number of enterprises
Housing ownership certificates "must have" this provision, in the end for the operation of the medical equipment business? Province Food and Drug Administration, this made it clear that this provision only for the business scope contains Class III implant materials and artificial organs, intervention equipment, medical electronic equipment class high-risk minority enterprises, and the class risk medical device products is for informational purposes only and medical institutions, professional physicians healed the sick.
Province Food and Drug Administration also said that the new introduction of the "Sichuan Medical Device Distribution Enterprise License inspection and acceptance criteria, the main principles of the masses of the people with armed security, effective, convenient, controllable risk, start-up business The small number of high-risk Class III medical devices varieties bid conditions.
Sichuan Province Food and Drug Administration official told reporters, "such as medical devices like pacemakers, once a problem, the tenants of housing ownership certificates relative tenants of housing ownership certificates, after the traceability will be better to do. "
Premises is not non-shops can not
Provincial Food and Drug Administration yesterday also revised standards further interpretation. Provincial Food and Drug Administration pointed out that the declaration of the "Medical Device Distribution Enterprise License enterprises in the province, does not necessarily require to shops, business premises, commercial office buildings, office buildings can be used as business premises.
“Cherish Your Life and Care About Your Health” is always the principle of our company. As a professional manufacturer of medical products, we will spare no effort to make great contributions to the development and improvement of medical industry.Choose perlong medical, you won't regret it, thank you for your visiting!
没有评论:
发表评论