What does China PTR do in Total Product Life Cycle?
With the release of Regulations on the Supervision and Administration of Medical Devices, Measures for the Administration of Medical Device Registration, and Measures for the Supervision and Administration of Medical Device Production(draft) in 2021, the product technical requirements (PTR) became one of the most important documents in the total product life cycle.
PTR is mandatory and one of the most important technical documents associated with China NMPA certificates. View the Guideline on how to write Product Technical Requirements (PTRs) released in February 2022.
Product design personnel should consider the performance requirements of the product, the standards, and guidelines etc.; they should also consider the formulation of qualitative and quantitative indicators in the product technical requirements, such as repeatability and operability of the test methods.
If the mandatory standards apply to the product, the PTRs must meet the mandatory standard requirements. It is important that the performance indicators in the PTRs are reasonably formulated. For example, if the product performance indicators are set too high, the product quality requirements are high, the product will be highly competitive in the market; however, the production cost of the product has increased.
The manufacturers send the product samples and the PTRs to the qualified testing institutes for testing. The testing is based on the PTRs submitted by the applicant. The testing institutes issues evaluation opinions on the submitted PTRs.
The registration of medical device products requires the submission of PTRs documents. Pay special attention to the following areas in PTR in relation to applicable mandatory standards:
- Performance indicators
- Repeatability and operability of the inspection methods
- Performance requirements of the clinical evaluation
- Comparison products
Based on the technical requirements and other materials, the medical device technical reviewer will evaluate its safety and effectiveness and issue the conclusive review opinions.
The applicant should check the PTRs, product characteristics, product technology, production process, quality management system which shall be formulated to the framework of factory inspection and release. Manufacturers shall ensure that the quality of the factory products meets the mandatory standards and the PTRs.
The implementation of quality control measures in the production process (such as: entry inspection, process inspection, factory inspection, etc.), formulation of work instructions, and raw material requirements are largely derived from PTRs. For example, the various inspection methods in the production process, and the indicators of whether semi-finished products or finished products are considered as integrated part of the technical requirements. The technical parameters of the process and the procurement requirements of raw materials are formulated according to PTRs to a large extent.
In the public tendering or bidding process of medical devices, bidders are generally required to submit product registration certificates and PTRs. The bidding unit usually pays attention to whether the performance indicators of the bidding products meet relevant requirements, and whether the formulation of the performance indicators meets the requirements of the bidding unit.
The national bureau or provincial supervision departments will carry out sampling inspection, based on PTR by a large extent.
Adverse Event Monitoring and Handling
Manufacturers and user facilities shall carry out adverse event monitoring of the medical devices. If a medical device manufacturer finds that the medical device does not meet the PTR, it shall immediately stop production, notify the relevant production and operation enterprises, user facilities and consumers to stop operation and use, and recall the devices. Take measures such as remediation and destruction, record relevant situations, release relevant information, and report the recall and disposal.