Approval of medical products on the Chinese market:
We offer complete solutions for the provision of import licenses of your products for the Chinese market. With our partners in China, we will carry out all formalities for you, such as preparing and submitting important documents to SFDA (State Food and Drug Admin), preparation and execution of product analysis and Labour test. This also includes the translation of your documents (German/Chinese/English).
Following documents are required:
- CPP ( Certificate of Phamaceutical Product )
- GMP (Good Manufacturing Practice)
- DMF (Drug Master File)
- CEP (Certificate of Suitability to the Monographs of the European Pharmacopeia)
- CMC ( Chemistry, Manufacture, and Quality Control)
- Safety Report
The whole processing takes about 19 Months for pharmaceutical Products and 12 Months for medical devices.
Quality-Test and Test-Report for medical products in Beijing:
With a test laboratory set up under German directives we offer you quality tests for your medical products in Beijing and prepare test reports for you, should you wish to purchase medical products in China and subsequently import them to Germany or Europe.
Some of our major clients:
- Lynton Lasers Ltd
- Gattefosse (Germany)
- Hedinger (Germany)
- NCPC Group (China)
- SCHÖLLY (China)
- Hafod Bioscience
- Geister Medizintechnik GmbH
- Gebrüder Martin GmbH & Co., KG