Q&A on registration of passive medical device “combination package” products
- Can combination package products be registered in the form of main and optional components
A：Consensus: The main selection form is acceptable, but the main accessories should reflect the main function. The main optional form is acceptable, but the main accessories should reflect the main functionality of the declared package products. Consensus: Enterprises should clarify the main and optional components that are suitable for the main functions of the product when applying for the first time; If there is a registration change, it should not affect the main function of the package product.
The selection of main and optional accessories for packages related to national registration guidelines shall be carried out in accordance with these guidelines; The selection of main and optional accessories for package products that do not currently have registration guidelines in the country should mainly focus on achieving clinical functionality. For non-medical device main and optional parts included in the package product, the registrant should carefully assess its use and risk.
2. If the components in the combined package products have obtained the registration certificate, it is hoped to clarify the principles for formulating the performance indicators in the technical requirements of the products
A: Consensus: If there are national guiding principles related to surgical bags, they should be executed according to the requirements of the guiding principles; Regarding package products that do not currently have registration guidelines in the country, the development of component performance indicators in the technical requirements for combination package products should adhere to the following principles:
(1) If the impact of sterilization on component performance is controllable, for ordinary level components that have obtained registration certificates and apply for package type sterilization products, the performance indicators can be described as products with medical device registration certificates, along with the main performance and sterilization related performance indicators.
(2) For components that have not obtained registration certificates, performance indicators are formulated in principle with reference to relevant country/industry standards.
(3) For components that have obtained a registration certificate, the performance index can be described as a product with a medical device registration certificate if it is only incorporated into the combination package through the outer packaging.
(4) If the effect of secondary sterilization on the performance of the sterilized components purchased from abroad is controllable, for the sterilized components that have obtained registration certificates, the performance indicators can be described as the products with medical device registration certificates and the main performance and sterilization-related performance indicators.
3.When registering for the first time, the performance indicators are required to be higher than the national standard/industry standard. Can the extensionregistration be carried out according to the national standard/industry standard?
A: Consensus: When registering for the first time, the performance indicators in the product technical requirements are higher than the national standard/industry standard of the declared product. When continuing registration, changing the product technical requirements can be executed according to the national standard/industry standard of the declared product.
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Article Source: Hubei MPA
Translated & edited ： Bradyknow
