What are the processes required to produce medical devices?

The manufacturing process and process of medical devices vary from one device to another. In general, the production process of medical devices includes the following steps: Design and R&D

The research and development of medical devices needs to go through multiple links such as design, testing, and correction to ensure the reliability and safety of products. Raw material procurement: The production of medical devices requires the use of various raw materials, including metals, plastics, electronic components, simple and resistant parts, etc.

Manufacturing: The manufacturing of medical devices often requires a variety of processes, including injection molding, die casting, sheet metal, welding, and more. Assemble:

The assembly of medical devices requires rigorous procedures and processes to ensure the quality and precision of each component. Inspection and testing: Various inspections and tests are required during the production process of medical devices, including visual inspection, dimensional measurement, electrical testing, etc.

Packaging and transportation: The packaging of medical devices needs to comply with relevant standards to ensure that the product is not damaged during transportation. The above is the general process of medical device production, and it may vary for different types of devices.

At the same time, the production of medical devices needs to comply with relevant laws, regulations and standards to ensure the quality and safety of products.

The medical device production process and process is a complex process, which usually includes the following steps:1Design & R&D:

The design and development of medical devices is the first step in the entire production process. This process usually requires multiple trials and modifications to ensure the quality and safety of the product. 2.

Raw material procurement: The production of medical devices requires the use of a variety of raw materials, including plastics, metals, electronic components, etc. These raw materials need to be sourced from reliable suppliers.

3.Manufacturing and processing: The manufacturing and processing of medical devices typically includes processes such as injection molding, stamping, welding, assembly, and more.

These processes need to be tightly controlled to ensure the quality and safety of the product. 4.Testing & Quality Control:

The packaging and transportation of medical devices need to comply with relevant standards and regulations to ensure that the product is not damaged during transportation. In general, the production process of medical devices needs to be strictly controlled and managed to ensure the quality and safety of products. At the same time, the production process needs to comply with relevant regulations and standards to ensure that the products meet the market demand and user needs.

According to the provisions of Articles 8 and 11 of the Measures for the Supervision and Administration of Medical Device Production, if a Class I medical device manufacturing enterprise is established, it shall go through the filing of Class I medical device production with the food and drug supervision and administration department of the city divided into districts where it is located; If a Class II or Class III medical device manufacturing enterprise is established, it shall apply for a production license from the food and drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government where it is located.

Articles 8 and 9 of the Regulations on the Supervision and Administration of Medical Devices (2014 Revision) stipulate that Class I medical devices shall be subject to product filing management, and Class II and Class III medical devices shall be subject to product registration management. Article 10 stipulates that for the filing of Class I medical device products, the filing person shall submit the filing materials to the local people's food and drug supervision and administration department of the city divided into districts. Article 11, to apply for the registration of Class II medical device products, the registration applicant shall submit the registration application materials to the people's food and drug supervision and administration department of the province, autonomous region and municipality directly under the Central Government.

To apply for the registration of Class III medical device products, the registration applicant shall submit the registration application materials to the food and drug supervision and administration department.

To sum up, enterprises that produce Class I medical devices need to go through the production filing with the food and drug supervision and administration department of the city divided into districts where they are located, and their products need to go through the product filing at the same time before they can be produced; Enterprises that produce Class II medical devices need to apply for a production license with the food and drug supervision and administration department of the province, autonomous region or municipality directly under the central government, and their products must be registered at the same time before they can be produced; Enterprises that produce Class III medical devices need to apply for a production license with the food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government, and their products need to be registered with the food and drug supervision and administration departments before they can be produced.

Medical device manufacturers should meet the following requirements:

1. Have a workshop site and environment that is suitable for the medical equipment produced.

2. Have professionals who are suitable for medical device products.

3. It has production equipment that matches the medical device products produced.

4. Institutions and professionals with medical device product inspection and supporting inspection equipment.

The establishment of a class I medical device manufacturing enterprise shall be filed with the drug regulatory department of the province, autonomous region and municipality directly under the central government, and the establishment of a class II and class III medical device enterprise shall be reviewed and approved by the pharmacy, and the business license issued by the administrative department for industry and commerce can only be obtained by obtaining the "medical device manufacturing enterprise license".

At the same time, if a medical device manufacturer requires the product to be sold and used in China, it needs to obtain a medical device product registration certificate before it can be allowed.

It is worth noting that medical device business enterprises and medical institutions shall purchase qualified medical devices from the manufacturers that have obtained the "Medical Device Manufacturing Enterprise License" or the business enterprises that have obtained the "Medical Device Business Enterprise License", and verify the product qualification certificate. Medical device business enterprises shall not operate medical devices that are not registered, have no qualification certificate, expire, become invalid or obsolete.

Medical institutions shall not use medical devices that are not registered, have no qualification certificate, are expired, invalid or obsolete.

Requirements for the use of medical device products: disposable medical device products shall not be reused, and the products that have been used shall be destroyed in accordance with national regulations.

As mentioned above, the promulgation of the "Regulations on the Supervision and Administration of Medical Devices" is a substantive regulatory document for medical devices in China, laying the foundation for China's medical device product specifications and providing a good policy environment for the development of the industry.

Headquartered in Guangzhou, Aoshida Medical Device Consulting Agency is the only medical device regulatory consulting organization focusing on the field of medical devices in China, with six branches in Beijing, Shanghai, Suzhou, Shenzhen, Jinan and the United States.

The procedures for the production of medical devices are: enterprises that produce Class I medical devices need to go through the production filing with the food and drug supervision and administration department of the city divided into districts where they are located, and at the same time handle the product preparation case; Enterprises producing Class II medical devices need to apply for a production license with the food and drug supervision and administration department of the province, autonomous region or municipality directly under the central government, and need to go through product registration at the same time.

Regulations on the Supervision and Administration of Medical Devices

Article 6. The state implements classified management of medical devices according to the degree of risk. The first type is medical devices with a low degree of risk, and the implementation of routine management can ensure their safety and effectiveness.

The second category is medical devices that have a medium risk and need to be strictly controlled and managed to ensure their safety and effectiveness. The third category is medical devices with high risk and need to take special measures to strictly control and manage them to ensure their safety and effectiveness. To evaluate the risk degree of medical devices, factors such as the intended purpose, structural characteristics, and use methods of medical devices should be considered.

The drug regulatory department is responsible for formulating the classification rules and classification list of medical devices, and analyzing and evaluating the risk changes of medical devices in a timely manner according to the production, operation and use of medical devices, and adjusting the classification rules and classification catalog. To formulate and adjust classification rules and classification catalogs, the opinions of medical device registrants, filing service providers, production and operation enterprises, user units, and industry organizations shall be fully heard, and the international medical device classification practice shall be referred to.