Kategorie-Archiv: News

Registration of Cosmetics Might Soon be Possible Without Animal Tests

Registration of Cosmetics Without Animal Tests.

On 05.02.2018, the NIFDC (National Institutes for Food and Drug Control) – a unit under the CFDA (China Food and Drug Administration) – published a draft on two alternatives to animal testing: One for skin and one for eye irritation.

The draft was open for public comment until 15.02.2018 and clearly indicates a major step towards the improvement of China’s technical cosmetics regulations and the replacement of animal testing in the future. Cisema will follow this development closely and will inform you as soon as the CFDA notice regarding the finalization of the two alternative methods is published.

For further information on this topic please contact:

Cisema GmbH
Tel.: +49 89 4161 7389 – 00

Trade Fair Dates

Trade Fair Dates.

Cisema regularly contributes to exhibitions – for instance in form of presentations in cooperation with professional associations or trade fair organizers.
2018 is also a busy year for us as we will be present at numerous exhibitions:

Medical Devices

28 Jan – 01 Feb            Arab Health Dubai, Dubai
23 Mar – 25 Mar           China Med, Beijing
02 Apr – 04 Apr            Rehacare & Orthopedic China, Guangzhou
11 Apr – 14 Apr            China Medical Equipment Fair Spring (CMEF), Shanghai
17 Apr – 19 Apr            Medtec Europe, Stuttgart
07 May – 09 May          Hong Kong International Medical Devices and Supplies Fair, Hong Kong
07 Jun – 09 Jun            China International Assistive Products Exposition (CIAPE), Beijing
09 Jun – 12 Jun            Sino-Dental, Beijing
17 Jul – 19 Jul               Florida International Medical Expo (FIME), Orlando
29 Aug – 01 Sep           China Dental Show (CDS), Shanghai
26 Sep – 28 Sep           Medtech China, Shanghai
11 Oct – 13 Oct            Care & Rehabilitation Expo China, Beijing
29 Oct – 01 Nov           China Medical Equipment Fair Autumn (CMEF), Shenzhen
31 Oct – 03 Nov           DenTech China, Shanghai
12 Nov – 15 Nov          Medica, Düsseldorf
23 Nov – 28 Nov          Greater New York Dental Meeting, New York

Cosmetics & Health Food

10 Mar – 12 Mar          China International Beauty Expo (CIBE), Guangzhou
15 Mar – 18 Mar          Cosmoprof Worldwide, Bologna
22 May – 24 May         China Beauty Expo, Shanghai
24 May – 26 May         Biofach China, Shanghai
17 Oct – 18 Oct           Cosmetic 360, Paris
14 Nov – 16 Nov         Cosmoprof Asia, Hong Kong

You are already our customer and would like to receive an update on your project progress?
You are not a customer but have questions regarding the registration of your product in China and would like to get to know us in person?

Let us know if you plan to visit one of the above mentioned trade fairs and we would be delighted to meet you. Please contact us to arrange a suitable time (E-Mail: afischer@cisema.com).

Additional CCC Certification Organization for Automotive Parts

Accreditation of CCC Certification Organization CAQC for Automotive Components.

The CNCA (Certification and Accreditation Administration of the People’s Republic of China) announced with its Notice No. 43-2017 that the CAQC (Cyberspace Administration of China) is allowed to process CCC (China Compulsory Certification) certification for product groups in the automotive sector. Among others: seat belts, horn, brake hose lines, exterior lighting and light-signalling devices, indirect vision devices, fuel tanks (metal and plastic), seat and headrests, child restraint systems. The previous certification scope included solely: interior and insulation materials, door locks and hinges.

Thus, applicants in the automotive sector have a new option to the previous duopoly of the organizations CQC (China Quality Certification Center) and CCAP (China Certification Center for Automotive Products).

For further information on the above topics, please contact:

Cisema GmbH
Tel.: +49 89 4161 7389 – 00
Fax: +49 89 7484 9956

CFDA: Funding for Testing of Medical Devices

Funding for Testing of Medical Devices.

On 17.11.2017 the CFDA (China Food and Drug Administration) published a notice announcing that fee-charging tests (also referred to as sponsored tests) are accepted as part of the CFDA registration of medical devices (No. 2017-187). In April 2017, the MOF (Ministry of Finance) had abolished most test fees for foreign products, resulting in a bottleneck due to laboratories going on strike. This policy evidentially failed and by re-introducing the option of fee-charging tests, a compromise between the State Council, CFDA and test laboratories is attempted. First laboratories have started to provide both test options. However, there are two uncertainties regarding fee-charging tests: Firstly, the timeline is unpredictable because the CFDA failed to specify a timeline in their regulation. Secondly, a failed test will result in the termination of the test and, subsequently, force the manufacturer to initiate a new test application.

For further information on this topic please contact:

Cisema GmbH
Tel.: +49 89 4161 7389 – 00
Fax: +49 89 7484 9956

15 Years in China Business

15 Years in China Business

Cisema celebrates its 15th anniversary – a joyful occasion to take a look at its company history.

The company was founded in 2002 by Stefan Fischer, shortly after China had become the 142nd member of the World Trade Organization (WTO).

China, the world’s most populated country, had just opened its doors and Stefan Fischer knew that this would bring great opportunities and challenges. He decided to build Cisema and to use his knowledge and skills to help companies enter China’s sales and procurement market.

Based on this idea, Cisema has developed a range of services with the main focus on certification, registration and licensing in the People’s Republic of China. Since China’s WTO accession, the Chinese government has made great efforts to adapt non-tariff trade barriers to international guidelines.

For example, in 2003, the current „CCC“ (China Compulsory Certification) was introduced in order to enforce uniform safety standards for electronic components, vehicles and their components. In 2006, the „CML“ (China Manufacturer License), the regulatory framework for pressure vessels, was modernized. New registration regulations for medical technology, pharmacy, cosmetics and nutritional supplements were issued in 2014 by the „CFDA“ (China Food and Drug Administration).

In addition to certification services, it is Cisema’s mission to help its customers make their purchases in China more effective with less effort. Cisema’s service packages include sourcing, supplier audits, pre-shipment inspections, as well as supplier development improving the process capability of Chinese suppliers.

Our customers have succeeded with their missions and have inspired Cisema to succeed and grow over the past 15 years. We started with one office in Munich and have grown to 5 offices across China as well as offices in Vienna, Chicago and Yangon. This makes it clear that Cisema keeps its promises and is always a good partner providing reliable support to its customers in penetrating the Chinese market.

Motorcycle Helmets Require Certification

Motorcycle Helmets Require Certification from 01.08.2018.

On 16.10.2017, the Chinese authority CNCA (Certification and Accreditation Administration of the P.R. of China) published in its Notice No. 32/2017 that the certification catalog for CCC is being extended to:

– Motorcycle helmets
– Electric blankets, heating pads and similar flexible heaters

From 01.08.2018, affected products may only enter, be distributed and used in the P.R. of China with a valid CCC certificate and labeling. Applications for the certification of helmets and electric blankets can be submitted starting from 01.11.2017.

An expansion on e-bikes is in the planning stage and is expected for 2018.

For further information on this topic, please contact:

Cisema GmbH
Tel.: +49 89 4161 7389 – 00

Acceptance of Foreign Clinical Trial Data

Enhanced Acceptance of Foreign Clinical Trial Data.

On 08.10.2017, the CPC Central Committee and State Council published “Deepening the Reform of the Examination and Approval System and Encouraging the Innovation of Pharmaceutical and Medical Devices (Draft for Comment)”. According to this, CFDA plans to accept foreign clinical trial data if it complies with Chinese requirements.

CFDA comments on the following aspects of clinical trial management:

a) Speeding up the review and approval of market entry
b) Promoting drug innovation and generic drug development
c) Strengthening the lifecycle management of pharmaceutical and MD
d) Improving technical support
e) Strengthening organization and implementation

For further information on this topic please contact:

Cisema GmbH
Tel.: +49 89 4161 7389 – 00


Standardizing the Classification of Medical Devices

CFDA Released a Note about Standardizing the Classification of Medical Devices. 

On 10.10.2017 the CFDA (China Food and Drug Administration) introduced in its Notice No. 2017/127 a specific work flow for the classification of medical devices, which applies to newly developed medical devices that had not yet been included in the „Medical Device Catalogue“. The regulation officially comes into force on 01.08.2018 but experience has shown that it will probably be applied in practice earlier than this.

For further information on this topic please contact:

Cisema GmbH
Tel.: +49 89 4161 7389 – 00