The most stringent regulations for medical device overseas inspection

On December 28th, 2018, National Medical Products Administration (NMPA) issued ‘Administrative Regulations of Drug and Medical Device Overseas Inspection’ (NMPA order No. 101 2018) implemented from the date of publication. Overseas inspection is the global common way for medical device inspection and one of the important steps for Chinese medical device inspection to be internationalized. The Regulations have essential effects for supervising overseas enterprises to comply with Chinese regulations.

NMPA is responsible for medical device overseas inspection. NMPA makes inspection tasks through risk evaluation and random selection in accordance with the suggestions of draft inspecting medical devices, R&D site and manufacturing site from relevant departments. Center for Food and Drug Inspection of NMPA (CFDI) is responsible for specific organization and implementation of medical device overseas inspection. Relevant departments will assist with the overseas inspection.

Overseas MAH shall submit CFDI ‘Letter of Authorization’ and ‘Basic Information Table of Overseas Inspecting Products’ in 20 workdays and submit main documents of inspecting site and other necessary materials in 40 workdays after receiving ‘Announcement of Overseas Inspection’.

There are several new regulations that overseas enterprises need to consider:

-Overseas inspection doesn’t only contain manufacturing site, but also includes overseas R&D location.

-Delay, obstruction, restriction and rejection for the inspection are all determined as ‘Fail’.

-If the enterprise has serious quality risk, NMPA will immediately conduct risk control measures.

-CFDI can acquire and inspect relevant technical files with crypto-security and include them into inspection files.

-The enterprise should keep normal condition and cooperate to inspect relevant equipment and sites. In accordance with inspection schedule, the enterprise shall arrange dynamic manufacturing process of inspected products and provide needed documents, records, e-data in time.

-If necessary, CFDI can sample and seal products with sampling documents. MAH shall ensure the package and transportation condition of the sample cannot affect sample quality.

CIRS Comments

NMPA clarify overseas inspection process and responsibilities of NMPA and overseas MAH through this regulations. Under this stringent regulations, overseas MAH should review and inspect all process and documents about R&D and manufacturing. They also have to ensure quality of the products and running conditions of the equipment. On the other hand, overseas MAH can consider to apply for being a domestic MAH in China. Shanghai is the first city that allow individuals or independent institutes as medical device MAH to authorize other factories to manufacture medical devices. In this way, overseas MAH can register their medical devices as domestic products in China.

To acquire CN version of the Regulations, you can download here.