NEWS

Current location:
Homepage
/
/
/
How are medical devices classified? What are the relevant laws and regulations?

How are medical devices classified? What are the relevant laws and regulations?

(Summary description)Medical devices are divided into three categories, one, two and three term management categories. According to the relevant provisions of the Regulations on the Supervision and Administration of Medical Devices, the management is from low to high. The state implements classified management of medical devices according to the degree of risk.

How are medical devices classified? What are the relevant laws and regulations?

(Summary description)Medical devices are divided into three categories, one, two and three term management categories. According to the relevant provisions of the Regulations on the Supervision and Administration of Medical Devices, the management is from low to high. The state implements classified management of medical devices according to the degree of risk.

1. Distinguish:

Medical devices are divided into three categories, one, two and three term management categories. According to the relevant provisions of the Regulations on the Supervision and Administration of Medical Devices, the management is from low to high. The state implements classified management of medical devices according to the degree of risk.
The first category refers to medical devices that are sufficient to ensure their safety and effectiveness through routine management. The first category is the low-risk medical device, which can be guaranteed to be safe and effective by routine management. Implement product filing management, which is approved, issued and registered by the supervisor of the municipal food and drug supervision and management department.

The second category refers to medical devices whose safety and effectiveness should be controlled. The second category is a medical device with moderate risk that requires strict control and management to ensure its safety and effectiveness. Implement product registration management management, which shall be reviewed, approved, issued and registered by the food and drug supervision and management departments of provinces, autonomous regions and municipalities directly under the Central Government.

The third category refers to medical devices that are implanted into the human body to support and maintain life, and are potentially dangerous to the human body, and their safety and effectiveness must be strictly controlled. Generally, it is approved, issued and registered by the State Food and Drug Administration. The third category is medical devices with higher risks that require special measures to be strictly controlled and managed to ensure their safety and effectiveness. The administration of product registration shall be implemented, and the approval, certificate issuance and registration shall be conducted by the food and drug regulatory department of the State Council in charge.

Note: To operate Category 1, you only need a license for the business scope; to operate Category 2, you need to do business filing; to operate Category 3, you need to obtain a business license.


2. To apply for the "Medical Device Operation Enterprise License", the following conditions should be met at the same time:

(1) It has a quality management organization or full-time quality management personnel that is commensurate with its business scale and business scope. Quality management personnel shall have relevant professional qualifications or professional titles recognized by the state;

(2) It has a relatively independent business place commensurate with its business scale and business scope;

(3) It has storage conditions suitable for its business scale and business scope, including storage facilities and equipment that meet the requirements of medical device product characteristics;

(4) It shall establish and improve the product quality management system, including procurement, purchase acceptance, warehousing, outbound review, quality tracking system and adverse event reporting system, etc.;

(5) It shall have the capability of technical training and after-sale service suitable for the medical device products it operates, or agree to provide technical support by a third party.
Those who apply for the "Medical Device Business Enterprise License" must pass the inspection and acceptance of the (food) drug supervision and management department.

Handling a case

When applying for the "Medical Device Business Enterprise License", the following materials should be submitted:

(1) "Medical Device Business Enterprise License Application Form";

(2) The enterprise name pre-approval certificate issued by the administrative department for industry and commerce;

(3) Photocopies of the ID cards, academic qualifications or professional title certificates and personal resumes of the quality management personnel of the proposed enterprise;

(4) The organization and functions of the proposed enterprise;

(5) Copies of the registered address of the enterprise to be established, the geographical location map of the warehouse address, the floor plan (with the area indicated), and the certificate of property ownership (or the lease agreement);

(6) The product quality management system documents of the proposed enterprise and the catalogue of storage facilities and equipment;

(7) The business scope of the proposed enterprise.

Legal Penalties:
Article 33 If a medical device business enterprise changes its quality management personnel without authorization, the (food) drug supervision and administration department shall order it to make corrections within a time limit. Those who refuse to make corrections within the time limit shall be fined not less than 5,000 yuan but not more than 10,000 yuan.

Article 34 If a medical device business enterprise changes its registered address and warehouse address without authorization, the (food) drug supervision and administration department shall order it to make corrections within a time limit, issue a circular for criticism, and impose a fine of not less than 5,000 yuan but not more than 20,000 yuan.

Article 35 If a medical device business enterprise expands its business scope and reduces business conditions without authorization, the (food) drug supervision and administration department shall order it to make corrections within a time limit, issue a circular for criticism, and impose a fine of not less than 10,000 yuan but not more than 20,000 yuan.

Article 36 Where the applicant conceals relevant information or provides false materials to apply for the "Medical Device Business Enterprise License", the provincial, autonomous region, municipality (food) drug supervision and administration department or the entrusted city (food) drug The regulatory agency shall not accept the application or shall not issue the "Medical Device Business Enterprise License", and issue a warning. The applicant shall not apply for the "Medical Device Business Enterprise License" again within one year.

Article 37 If an applicant obtains the "Medical Device Operation Enterprise License" by deceit, bribery or other improper means, the (food) drug supervision and administration department shall revoke its "Medical Device Operation Enterprise License", issue a warning, and impose a penalty on it. A fine of not less than 10,000 yuan but not more than 20,000 yuan. The applicant shall not apply for the "Medical Device Business Enterprise License" again within 3 years.

Recommended news

SEARCH YOUR NEEDS

Search
Confirm
Cancel

info@QJMDMGAUZE.COM     info@KINGPHAR.CN

Contact Us

tel

Telephone:+86 27 8575 9366

tel

Fax:+86 27 8575 9368

tel

Mobile(WhatsApp, Wechat):
0086 15384407182

language
中国
韩国
韩国
韩国
韩国
韩国

Quick Navigation 

Focus  Us

Focus  Us

Contact  Us

Contact  Us