On March 31, 2015, the State Food and Drug Administration issued the "Announcement on Issues Concerning the Renewal of Registration Application Documents for Medical Devices (Including In Vitro Diagnostic Reagents) (No. 144)". This announcement is mainly aimed at the new registration management method. When it comes to product renewal registration, the registration applicant's original approved registered product standards are lost and the original registered product standards or a copy thereof cannot be provided.
Through the analysis of this announcement and the experience of handling a large number of complex cases, we learned that if a company involves the loss of the original approval standards when applying for product registration renewal, it should submit the following information:
List of documents Data name
1 Explanation of the reasons why the company failed to provide a copy of the standards
2 Product standards (without the seal of the General Administration)
3 Submitted standards Statement of consistency with the content of the previously filed documents
4 Description of how to ensure that products are in compliance with registered product standards when they are launched in China
5 Letter of commitment to revoke the registration application if the content is untrue.
When an enterprise obtains a medical device registration certificate, it will also obtain product registration standards (product technical requirements) approved by the competent food and drug administration bureau. Product registration standards (product technical requirements) are important for manufacturing companies. An important guarantee to ensure product quality, according to the provisions of Article 66 of the State Council Order No. 650 of the "Regulations on the Supervision and Administration of Medical Devices":
Production, operation, and use do not comply with mandatory standards or do not comply with registered or Medical devices with registered product technical requirements;
Medical device manufacturers fail to organize production in accordance with registered or registered product technical requirements, or fail to establish a quality management system and maintain effective operation in accordance with the provisions of these regulations.
The food and drug supervision and administration department of the people's government at or above the county level shall order corrections and confiscate the medical devices illegally produced, operated or used; if the value of the medical devices illegally produced, operated or used is less than 10,000 yuan, A fine of not less than 20,000 yuan but not more than 50,000 yuan shall be imposed; if the value of the goods exceeds 10,000 yuan, a fine of not less than 5 times but not more than 10 times of the value of the goods shall be imposed; if the circumstances are serious, the company shall be ordered to suspend production and business until the original issuing department revokes the medical certificate. Device registration certificate, medical device production license, medical device business license:
Therefore, the production of products after they are launched must comply with the product registration standards (product technical requirements). CIRS Group recommends that companies After obtaining product registration standards (product technical requirements), you should pay attention to the following points:
Key points Chinese domestic enterprises and overseas enterprises
1 Copy the approved product registration standards (product technical requirements) cover The company's official seal must be filed with the local Food and Drug Administration and Quality Supervision Bureau. The manufacturing company needs to keep the original copy of the approved product registration standards (product technical requirements), and send the copy with the company's official seal/signature to the Chinese agent.
Chinese agents should register with the local Food and Drug Administration.
2 Product registration standards (product technical requirements) are included in the quality system as enterprise-controlled documents. Product registration standards (product technical requirements) are included in the quality system as enterprise-controlled documents.
3 Organize various departments within the enterprise to study and implement the approved documents. Organize the study and implementation of approved documents by various departments within the enterprise.
4 Produce and inspect in accordance with the requirements of the approved product registration standards (product technical requirements) to ensure that the products leave the factory and meet the requirements of the product registration standards (product technical requirements). Produce and inspect in accordance with the requirements of the approved product registration standards (product technical requirements) to ensure that the products leave the factory and meet the requirements of the product registration standards (product technical requirements).
For medical device manufacturers, the renewal registration of medical devices will be subject to new regulations starting from April 1, 2015. The renewal registration has officially replaced the expired re-registration. At the same time, the change of registration and the renewal of registration require separate applications. Correspondingly The application deadline and approval process have also been adjusted. Companies should closely follow the developments in medical device regulations and apply for registration changes or renewals in a timely manner to ensure the effective use of medical device registration certificates.