Kategorie-Archiv: News

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
info@cisema.de
www.cisema.com

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
info@cisema.de
www.cisema.com

 

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
info@cisema.de
www.cisema.com

Extension of Cross-Border E-Commerce Policy

Extension of Ccross-Border E-Commerce Policy Grace Period.

During the meeting of the Chinese State Council on 20.09.2017, it was decided to extend the CBEC Policy Grace Period for a second time. The regulation allows the introduction of unregistered cosmetics, medical devices, infant formulas and health foods into Chinese cross-border cities until 31.12.2018.

For further information on this above topic, please contact:

Cisema GmbH
Tel.: +49 89 4161 7389 – 00
info@cisema.de
www.cisema.com

New CFDA-Catalogue for Medical Devices

CFDA published a new catalog for the classification of medical devices.

The CFDA (China Food and Drug Administration) published a new classification catalog on 31.08.2017 (No. 2017-104). The new catalog, with more than 2,000 entries of product classifications, is much more extensive than the previous catalog, which featured only around 200 product examples. It is clear that many product classifications will change as of 1 August 2018, when the new catalog and its implementation regulations are put into effect. Excluded from this are in-vitro diagnostics reagents, as their currently used classification guidelines will remain valid.

  Old Classification Catalogue New Classification Catalogue
Entries of product examples

~200

>2,000

Categories

43

22

Class I subcategories

104

380

Class II subcategories

123

777

Class III subcategories

7

404

CFDA revised two regulations regarding food for special medical purposes

On 6 September 2017, CFDA published announcement (No. 2017-108), in which the „Application Documents and Requirements for the Registration of Food for Special Medical Purpose (Trial)“ and the „Stability Research Requirements on Food for Special Medical Purpose (Trial)“ are revised.

Certification requirement for all food imports to China is suspended until 30 September 2019

As mentioned in our Foreign Trade News from July 2017, food products should only be imported in China with an official certificate of clearance as of 01.10.2017. The WTO (Word Trade Organization) is now circulating a communication (dated 22 September 2017) on behalf of AQSIQ (General Administration of Quality Supervision, Inspection and Quarantine) announcing that, on the basis of the comments received, a transitional period of 2 years will be granted.

For further information on the above topics, please contact:

Cisema GmbH
Tel.: +49 89 4161 7389 – 00
info@cisema.de
www.cisema.com

China RoHS 2.0 „Compliance Management Catalog“

China RoHS 2.0 „Compliance Management Catalog“ progressing to next phase.

On February 3rd 2016 the responsible authorities (published an update on the regulation for hazardous substances – RoHS 2.0. The regulation is effective since July 1st 2016 (we reported).

Originally a „Compliance Management Catalog“ was scheduled for publishing in October 2016. The content should provide a definition, whether a mandatory registration, and possibly an inspection of the manufacturer, will be introduced. So far there was no progress. On July 28th 2017 a consultation of the authority MIIT with business representatives ended. We expect to receive further information about the future approaches for China RoHS by end of this year.

For further information please contact:

Cisema China Certification GmbH
Tel.: +49 89 4161 7389 00
Fax: +49 89 7484 9956
info@cisema.de
www.cisema.de

 

Certificate of Clearance for all Food Imports

AQSIQ is planning to introduce an official certificate of clearance for all food imports.

On 1.10.2017 announcement 83 2017 issued by AQSIQ (Administration for Quality, Safety, Inspection and Quarantine of China) will come into force. From then on, all food exported to China must be accompanied by an official certificate of clearance, which is to be issued by the competent authorities in the country of origin. Up to now, AQSIQ has not communicated any details, like which authorities are accepted by AQSIQ or which information is to be contained in the certificate.

Many of China’s trade partners have already filed a note of protest at WTO against this regulation and the feasibility of the Chinese plans is most uncertain according to expert opinions.

We shall inform you immediately, if there are any news on the certificate of clearance.

For further information please contact:

Cisema GmbH
Tel.: +49 89 4161 7389 00
Fax: +49 89 7484 9956
info@cisema.de
www.cisema.com

CFDA Formulates Confidentiality Measures

CFDA has Formulated Confidentiality Measures in Regards to Review and Approval of Drugs and Medical Devices.

In order to protect the rights and interests of the manufacturer of pharmaceuticals and medical devices, CFDA (China Food and Drug Administration) issued a code of confidentiality for all employees involved in the registration process.

According to the code, all employees involved in a registration process must sign a confidentiality agreement, whose compliance is strictly monitored. Should an employee be in violation of the agreement, he will be punished. Depending on the severity of the failure, the consequence is a disciplinary punishment which can range from a written warning or dismissal up to legal action against the employee.

If the applicant of the registration can prove that the information disclosed by relevant staff or expert leads to losses, he has the right to file a lawsuit.

If the CFDA pays a compensation according to the judgment of people’s court, they will reclaim part or all of the compensation costs from the violating employee or expert.

For further information please contact:

Cisema GmbH
Tel.: +49 89 4161 7389 00
Fax: +49 89 7484 9956
info@cisema.de
www.cisema.com