In order to improve the quality of an approved medical device product, companies will often improve the supply chain by changing production equipment, raw materials, production processes, inspection methods and quality control standards.
Any change in raw material in medical device products may affect the safety and efficacy profile of the product. It is necessary to ensure requirements of regulations will be met by evaluating the possible impact and taking measures to reduce these risks.
China’s NMPA issued a guidance (No 33. 2020) on May 19, 2020 to provide a guideline and systematic approach for risk analysis of raw material changes in passive medical device products and to aid the companies in regulating the design and development of related products, registration declaration and quality control.
Change in Raw Material Evaluation Process:
Risk management is crucial throughout the entire life cycle of a medical device product. After a change of raw material in medical device products, risk management ensures adverse event are monitored and ensures safety and efficacy of medical devices by maximizing the control of potential risks of medical device.
Providing guidance on the risks of all material changes is not feasible and the guideline that follows describes commonly used paths in risk evaluation and management.
1. Determine whether there is a change in raw material
A change might include;
- material type,
- material composition,
- method and/or ratio,
- or preparation process.
2. Identify the patterns of change & perform risk analysis of the impact on medical device products
Risk analysis can include;
- product physical and chemical performance risk, biocompatibility,
- biosecurity hazards,
- sterilization effects and residues,
- expiration dates,
- and any other impact on safety and effectiveness risk.
3. Develop risk assessment through non-clinical evaluation
In Biological evaluation:
- First, determine change in raw material has direct or indirect contact with human body;
- Second, determine whether the change in raw material is causing any new biological hazard;
- Also, determine whether same materials have been used in similar marketed devices.
In laboratory research (to evaluate impact of changes on product performance, sterilization, validity, etc):
- First, determine whether change in raw material affects physical and chemical performance
- Second, determine other risks within the scope of the safety/effectiveness list, design and development procedures, and other documentation provisions, such as disinfection, sterilization effect, residues, expiration date.
4. Perform further verification through clinical evaluation and assessment of any remaining risks.
In clinical evaluations:
- If the medical device is exempt from clinical trials, evaluate risks in accordance with the Technical Guidelines for Clinical Evaluation of Medical Devices (State Food and Drug Administration No. 14 of 2015)
- If the medical device product is not exempt, consider whether the raw material change and the approved product are the same in terms of basic principle, structural composition, manufacturing materials, production process, performance requirements and/or safety evaluation, or the difference does not adversely affect the safety and effectiveness of the product.
5. Continue evaluation through risk control measures and risk benefit analysis
After assessment of risks, continue evaluation through risk control measures and risk benefit analysis in accordance with standards such as YY/T 0316 applied to medical devices, until change is rejected, or risk reduction is at an acceptable level.
What is a Passive medical Device?
A Passive MD is defined by the NMPA as a device that does not rely on electrical energy or other energy sources but can use the energy generated by the human body or gravity to exert their functions.
What is a YY/T Code?
The standard code for the medical device industry is composed of capital Chinese pinyin letters. The code of the mandatory industry standard is “YY”, and the code of the recommended industry standard is “YY / T”.
The industry standard number consists of the industry standard code, the standard number, and the year
number of the standard release.
Its form is: [ YY ×××× 1- ×××× 2 and YY / T ××××× 1- ×××× 2. ]
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