The commissioned production of medical devices is like a well-planned dance. On this stage, medical device registrants and filing persons can choose to dance this dance by themselves, or they can find a partner to dance together. However, no matter which way you choose, make sure that the dance is of good qualityThe NMPA is like a strict dance teacher, and they will give strict guidance and supervision to this dance. They even published a "Catalogue of Prohibited Consignment Production" of medical devices, which is like a list of dance taboos that tells you which movements you can't do.
There are a few small details to pay attention to while dancing:
1.Do not exceed the scope of your own dance, that is, do not exceed the production scope specified in the medical device production license. This means that, as a client, you need to understand your own capabilities and qualifications to ensure that the medical devices you are commissioned to produce are in line with your business scope.
2.Do not dance in an unlicensed place, that is, do not produce Class II or Class III medical devices in an unlicensed production site. This requires the entrusting party to ensure that the other party has legal production qualifications and premises when selecting a partner, so as not to violate the law.
3.The dance license has expired, so you have to renew it in time, otherwise you won't be able to continue dancing!For Class II and Class III medical devices (including innovative medical devices) in China, they can choose to contract production. However, in the process of consignment, it is important to ensure that the technique, movement and quality of the dance are consistentThis means that the client needs to maintain close communication with the partner to ensure that the production process runs smoothly.
In short, the commissioned production of medical devices is a rigorous and complex dance. The success of the dance can only be ensured if the relevant regulations are followed. In this process, the NMPA will always stand on the stage** to provide guidance and support to every participant. Let us work together to improve the level of China's medical device industry
Entrusting a third party to produce medical devices, and the entrusting party's violation has some impact on the entrusting party
According to Article 34 of the Measures for the Supervision and Administration of Medical Device Production, medical device registrants and record-filing persons can produce medical devices by themselves, or they can find a reliable company to help. In the process of finding someone to help, the two parties should sign a "Medical Device Commissioned Production Quality Agreement" to clarify their respective responsibilities and obligations. If the entrusted party does not follow the rules, it may cause the following troubles to the entrusting party:1Legal issues: Depending on the severity of the violation, the client may have to lose money, recall the product, or even lose the manufacturing license. 2.Economic loss**: The client may be liable for the cost of a recall and a consumer claim because non-compliant production may lead to product quality problems. 3.Damage to brand reputation: In the event of a non-compliance, it may cause damage to the client's brand reputation, affecting its reputation and sales in the market. 4.Regulatory risk: Principals may face increased regulatory scrutiny, increasing compliance costs in the future. Therefore, when the entrusting party chooses a third party for the production of medical devices, it should fully understand the qualifications and production capacity of the entrusted enterprise, ensure that it meets the requirements of relevant laws and regulations, and sign a clear contract and quality agreement with it to ensure the compliance of the production process and the stability of product quality.
How to choose a good delegate
When choosing the entrusted party for the commissioned production of medical devices, the following aspects should be considered: 1Professional ability: You have to find someone who knows how to produce in accordance with the production requirements of medical devices. Take a look at their past experience and certifications to get an idea of their level in the medical device field. 2.Production equipment and technology: You have to find one with advanced equipment and technology that can meet the production needs of medical devices. You can visit their workshop to see their equipment and technical level. 3.Quality management system: You have to find a perfect quality management system that can ensure the quality and safety of medical devices. You can take a look at their quality certification certificates and related documents to understand their quality management. 4.Production capacity and delivery time: You have to find someone who has enough production capacity to deliver the required medical devices on time. You can communicate with them to understand their production capacity and delivery time. 5.* and service: you have to find a reasonable and good after-sales service. You can compare with multiple entrusted parties and choose a partner with higher cost performance. 6.Credibility and reputation: You can understand the credibility and reputation of the entrusted party by consulting relevant information and consulting other customers. Choosing a party with a good reputation and reputation can improve the stability and reliability of cooperation. To sum up, when choosing the entrusted party for the commissioned production of medical devices, it is necessary to comprehensively consider their professional capabilities, production equipment and technology, quality management system, production capacity and delivery time, ** and service, as well as reputation and reputation and other factors to ensure that the right partner is selected.