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Medical Devices Quality Mgt.

Ensure Safe Medical Devices

The medical device manufacturing sector is one of the most regulated sectors in which significant quality systems and product requirements must be satisfied. The regulatory requirements are intended to ensure that manufacturers consistently design, produce, and place onto the market, medical devices that are safe and fit for their intended purpose.

TQM’s Involvement in ISO 13485 Medical Devices Quality Management System

Pioneer in “CE Marking and EN 46000 Project”

Early in 1999, TQM has obtained HKSAR Government Funding to assist practitioners in the medical equipment industry to establish ISO 13485 MD-QMS (called EN 46000 then), ISO 9001 QMS and CE Marking to enter the European Market. Collaborating with IIE (HK), TQM is the1st private organization that obtained the Industrial Support Fund of the HKSAR Government to a “CE Marking and EN46000 Project” for medical devices manufacturers.

Through this project, TQM helps manufacturers to meet requirements of EU importers, fulfils the requirements of CE & EN 46000, and obtains the marking and certification. (Note: CE Marking is the threshold for manufacturers of medical devices to enter EU market; EN 46000 is the quality management systems for medical devices in accordance with some particular requirements)

With our exceptional real industry experience, TQM has been providing professional support to dozens of companies in obtaining ISO 13485 MD-QMS/ FDA/ ISO 9001 QMS/ CE Marking, including Emerson, Ewig, Item, Fuji Dynamics, Modern Medical Equipment, Filligent, GE, Jacobson Medical, Perfect Ceramic Dental, Well Dental Laboratory, Golden Horse Medical Equipment, Plenty Source, Eagletron Telecommunications, Wai Tat, Season, Wing Hing, etc.

TQM’s Rich Experience in Medical/ Healthcare Industry and ISO 13485

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Case Sharing of ISO 13485

CE Marking for Masks

Facing the pandemic of Coronavirus, medical devices such as medical masks are becoming people's daily essentials. Many countries and regions have certification or registration requirements for imported medical devices, for instance EU CE certification. The Hong Kong mask manufacturers need to comply with relevant certifications to enter the foreign countries where potential or target audiences are located. At the same time, they must ensure their mask product technical documents including relevant certificates and reports are valid. There are lots of CE Compliance certificates in the market yet by having that does not means that their masks are registered in the EU database.

For further information, please access to this link or the following QR code.

CE Registration

Different types of medical equipment require completely different application processes. The classification of medical equipment is based on a "risk management-based" system looking at human weakness, while taking into account the potential risks associated with the equipment. This method allows the use of a set of criteria that can be combined in various ways in order to determine the classification. For example: the duration of contact with the body, degree of invasion, and local and systemic effects. According to the listed Appendix IX of Directive 93/42/EC, these standards can then be applied to a variety of different medical devices and technologies.









According to the requirements of MDD or MDR, medical non-sterile masks can be sold on the market after the manufacturer adopts a self-declaration method and affixes the CE mark. Yet, the sterile medical masks must be assessed by the notified body before they can be marketed with the CE mark. Regardless of whether compliance assessment by the notified body is required, manufacturers need to test in accordance with regulatory requirements. Manufacturers need to refer to relevant standards that meet EU quality requirements, to verify product safety and effectiveness, and establish technical files and quality control systems to ensure product quality and safety and lasting.

The quality system can be carried out with reference to the harmonized standard ISO 13485:2016. For the conformity assessment of the notified body, the ISO 13485 certification is not necessary or mandatory but most manufacturers will choose to obtain as it can improve customer confidence towards the manufacturer's ability in meeting regulatory requirements and product quality assurance. 


For manufacturers outside the EU (such as those in Hong Kong), it is necessary to authorize a representative in the EU to perform relevant activities in the EU on behalf of the manufacturer, such as registration of self-declared products and reporting of adverse events with the competent authority. Manufacturers need to sign agreements with authorized representatives and specify their respective responsibilities. According to the new MDR regulations, manufacturers need to submit a complete set of technical files to the representative for review by the competent authority.



How can TQM help?

TQM can assist manufacturers to complete the CE registration process within 2-4 weeks, allowing exports towards foreign countries.

For further information on Mask CE certificate procedures and fees, please kindly leave us your contact details and we will reach out to you asap or feel free to contact us via 2569 2883.

Huge change in the EU market - MDR taking place

Basically all masks in the current market are registered under Medical Device Directive MDD 93/42/EEC, yet MDD will be replaced by MDR by May 2021. Since MDR is more complicated, it is expected to take up longer time for the completion of the registration process.

Specific changes from the change: 

1. New application on CE certificate will need to follow MDR 

2. Starting from 27th May 2021, any products that do not have CE certificates will need to apply MDR rules

3. All MDD certificates signed before 26th May 2021 will be valid until its expiry date, latest by 26th May 2024