Regulatory Open Forum

China GMP requirements have been increasingly strict, not only for domestic inspections, but also overseas ones. In 2019, 24 manufacturers have been cited for violations and defects, including some big players.

To prepare for overseas inspection, you should follow NMPA (CFDA) Administrative Regulations of Drug and Medical Device Overseas Inspection issued on December 28th, 2018.

The document states that NMPA makes inspection tasks through risk evaluation and random selection in accordance with the suggestions of draft inspecting medical devices, manufacturing site, and R&D 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.

NMPA clarifies overseas inspection process and responsibilities of NMPA and overseas MAH through these new 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. Beijing, Shanghai, Guangdong and Zhejiang, among the total of 21 provinces, 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.

If you want an English copy of Administrative Regulations of Overseas Inspection, or have any idea for NMPA inspections, please leave your comments here or email me at gpalma@ChinaMedDevice.com.

China GMP requirements have been increasingly strict, not only for domestic inspections, but also overseas ones. In 2019, 24 manufacturers have been cited for violations and defects, including some big players.

To prepare for overseas inspection, you should follow NMPA (CFDA) Administrative Regulations of Drug and Medical Device Overseas Inspection issued on December 28th, 2018.

The document states that NMPA makes inspection tasks through risk evaluation and random selection in accordance with the suggestions of draft inspecting medical devices, manufacturing site, and R&D 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.

NMPA clarifies overseas inspection process and responsibilities of NMPA and overseas MAH through these new 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. Beijing, Shanghai, Guangdong and Zhejiang, among the total of 21 provinces, 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.

If you want an English copy of Administrative Regulations of Overseas Inspection, or have any idea for NMPA inspections, please leave your comments here or email me at gpalma@ChinaMedDevice.com.

China GMP requirements have been increasingly strict, not only for domestic inspections, but also overseas ones. In 2019, 24 manufacturers have been cited for violations and defects, including some big players.

To prepare for overseas inspection, you should follow NMPA (CFDA) Administrative Regulations of Drug and Medical Device Overseas Inspection issued on December 28th, 2018.

The document states that NMPA makes inspection tasks through risk evaluation and random selection in accordance with the suggestions of draft inspecting medical devices, manufacturing site, and R&D 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.

NMPA clarifies overseas inspection process and responsibilities of NMPA and overseas MAH through these new 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. Beijing, Shanghai, Guangdong and Zhejiang, among the total of 21 provinces, 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.

If you want an English copy of Administrative Regulations of Overseas Inspection, or have any idea for NMPA inspections, please leave your comments here or email me at gpalma@ChinaMedDevice.com.