Mask&Forehead Thermometer Registration

 一、Applicable Area

Production enterprises in provinces (municipalities directly under the Central Government) where the contingency registration and approval policies for epidemic prevention supplies continues to take effect (consult ZOOP for details)can apply for the contingency registration certificate to the city-level joint prevention and control material security department (industry and information department)  or the market supervision and administration department, regardless of whether they were originally mask manufacturers.With this certificate, a company may apply for product  contingency registration certificate and production license to the provincial drug regulatory authority.

 

The contingency registration certificate is valid for the epidemic prevention period (mostly one-year validity period). Before the expiration, the registration certificate and production license of class II medical devices must be obtained before the production and sales can proceed.

 

The conventional registration certificate shall be valid for 5 years and shall be renewed every 5 years.

 

二、Product Range and Type

Masks: disposable medical masks, surgical masks, protective masks.Sterile or non-sterile.

Instant Read Thermometer (equipment) : forehead thermometer, ear thermometer, quick infrared thermometer.

 

三、Basic Conditions

About site:The layout shall be reasonable, with independent materials, packaging materials and finished product warehouses, inspection rooms, and production workshops. The scale shall meets the needs of production and is planned according to the specific conditions of each customer.

 

About workshop: non-sterile masks can be produced without purification, but corresponding sanitary control measures are required.The production of sterile masks must be at least a Grade D purification workshop.

 

About inspection: Production of masks and protective clothing requires a microinspection room.Forehead thermometers and ear thermometers shall have measuring equipment (room)

 

About equipment: General equipment,inspection equipment that required for production(if outsourcing inspection is available, these are not required)

 

About product: It shall meet the technical requirements of the corresponding products and pass the necessary tests. The ZOOP's technician will advise the specific test items after the project is officially start.

 

About staff: It shall have the necessary personnel for production, such as quality inspection personnel, production personnel.Personnel shall meet the basic qualification requirements.

 

About management: It shall meet all the conditions of the  to ensure the Good Manufacturing Practice for Medical Devices to ensure the continuous conformity of product quality.

 

四、Process

Procedures for contingency registration

The enterprise applies to the local industry and information department or the market supervision department——the mentioned department evaluates and issues a certificate (may need to see the site)-trial product submission——test completed——compilation of registration information——submit for registration-review and accept by provincial NMPA——submit application for QMS review——on-site review of factory by the NMPA——technical review——approval——administrative approval——issuance of contingency registration certificate.

The general registration process is basically the same.

 

五、Period

Contingency Registration

Under the premise that the factory meets the requirements (site, personnel, management) and the equipment and materials are in place,the registration of masks is expected to be 2-3.5 months from the time of product test, and the registration of temperature measuring equipment is expected to be 3-4 months.

 

It varies according to the location of the plant, the production of sterile and non-sterile products, and the basic conditions of the factory.

 

General Registration

Since the preliminary emergency registration has met the requirements, the routine registration is expected to be about 6-8 months from the start of product test, which is related to the basic conditions of the factory itself and the review period of the drug regulatory department.

 

六、 Documents Required for Registration

1. Application form(for contingency registration).

2. Application form(for general registration).

3. List of safety and and effectiveness of medical devices.

4. Business License.

5. Proof of venue use.

6. Summary data and research data.

7. Manufacturing information

8. Clinical evaluation data and product risk analysis data(It will be prepared by ZOOP’s technician).

9. Technical requirements for products.

10. Product test report.

11. Product manual and label sample draft of the minimum sales unit.

12. Declaration of conformity.

( The information submitted for contingency registration and regular registration is basically the same).

 

Special instructions

Contingency registration and routine registration have the same requirements for factory conditions. Compared with regular registration, the biggest difference is that special procedures are adopted for testing and authority review, which greatly shorten the period, facilitate enterprises to organize production quickly and increase the supply of prevention and control materials.

 

Available Services from ZOOP

Related services for contingency registration:

1.  To guide enterprises in applying for emergency registration.

2.  Provide technical requirements for product and compile manufacturing information.

3.  Make test application form and guide product delivery for testing.

4.  Prepare product manual and labels writing

5.  Instruct the factory to plan the site (if client needs).

6.  Make clinical evaluation of the product.

7.  Prepare risk analysis report.

8.  Legal training for factory personnel.

9.  Provide the QMS document template (level 1&2), guide the production of the QMS document, and pre-review the document.

10、1-2 people to the factory for training guidance and pre-review system.

11. Compile application materials for products and production registration, submit registration materials, and in charge of following up technical and regulatory issues in the registration and application process until obtaining registration certificate and production license.