Product Safety and Marketing Labels

Product Safety and Marketing Labels

All medical device products sold by BenQ Materials must obtain the national regulatory approvals and certifications required in each sales region before being exported and sold in various countries. Certifications obtained to date include Taiwan TFDA, EU CE, U.S. FDA, China NMPA, Japan PMDA, and Southeast Asia ASEAN certifications. For details.Throughout the full lifecycle of medical device products, from product development to withdrawal from the market, the design, implementation, recording, and reporting processes for verification testing of functionality and safety must comply with international standards and regulations. This ensures that product functionality and safety verification is conducted scientifically and produces reliable results. For example, such requirements include ISO 14971: 2019, the standard for medical device risk management, and ISO 14155: 2020, the guideline for clinical investigations of medical devices. Medical device products that come into direct contact with the human body must also pass biocompatibility testing under the ISO 10993 series.

Countries	Applicable Product Regulations
Taiwan	Medical Devices Act
EU (applicable to all Member States)	MeEuropean Medical Device Regulation(MDR) 2017/745
USA	LUS Federal Food, Drug and Cosmetics Act, FD&C Act
China	Regulations on the Supervision and Administration of Medical Devices
Malaysia	Laws of Malaysia Act 737 Medical Device Act 2012
Singapore	HEALTH PRODUCTS ACT(CHAPTER 122D) & HEALTH PRODUCTS (MEDICAL DEVICES) REGULATIONS 2010
Thailand	Medical Device Act/Ordinance B.E. 2562 (2019)
Indonesia	Permenkes 62-2017 Circulation of medical devices, in vitro diagnostic medical devices and household health products
Vietnam	Decree no.98/2021/ND-CP on Medical Device Management
Japan	Act on Ensuring Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, etc. (Pharmaceutical Device Act)

 

Manufacturing and Sales Licenses for Medical Device Products

BenQ Materials is a medical device manufacturer. The design, manufacturing, sterilization, and distribution processes for all self-manufactured products have obtained international certification under ISO 13485: 2016, the quality management system standard for medical devices. In Taiwan, the Company has been approved and registered by the competent health authority and has obtained a medical device manufacturer license and QMS manufacturing approval. Product sales also require a medical device seller license and product registration approval. Products may then be sold to end consumers through physical channels or distance-selling channels, where permitted, operated by medical device firms holding medical device seller licenses.

 

Medical Device Product Labeling and Marketing Regulations

Transport Packaging Labeling Requirements

• 1. Transportation packaging shall be clearly, legibly, and permanently marked with the product catalog number, quantity, manufacturer or supplier name/ trademark, production date in compliance with the ISO 8601 date format, batch number, nominal weight per square meter in grams, roll width in centimeters and length in meters, and recommended storage conditions.
• 2. Labels inside inner packaging or rolls shall be clearly, legibly, and securely marked with quantity, manufacturer or supplier name/trademark, batch number, and nominal weight per square meter in grams.

 

Medical Device Product Labeling Requirements

In addition to complying with medical device product regulations in the country of sale, BenQ Materials labels its medical device products in accordance with ISO 15223-1: 2021, Medical devices-Symbols to be used with information to be supplied by the manufacturer-Part 1: General requirements, and prepares product disclosure information based on the labeling symbols specified in the standard.

For products regulated under Taiwan’s Medical Devices Act, necessary information must be included on medical device labels, instructions for use, or packaging. This includes product name, license number or registration number, efficacy/purpose or indications, manufacturing date/effective period or shelf life, model/specification or main ingredients, warnings/precautions/ use restrictions or expected foreseeable side effects, name and address of the license holder or registrant, name and address of the manufacturer, batch number or serial number, and other information required by announcements of the central competent authority.

 

Medical Device Product Marketing Requirements

Medical device-related products must comply with applicable medical device advertising and marketing laws and regulations in each country. Taking Taiwan as an example, before conducting medical device advertising and marketing, all advertising text, images, verbal statements, and other information must be submitted to the competent authority for approval before publication or broadcasting. Promotional methods are also subject to relevant restrictions and may not be conducted under another person’s name, through books/documents, interviews, or other improper methods.

Taking contact lenses as an example, as products regulated under the Medical Devices Act, their advertising and promotional methods, whether in print or media advertisements, must comply with the Ministry of Health and Welfare’s regulations governing the review of medical device advertisements. The Taiwan Food and Drug Administration under the Ministry of Health and Welfare issues notices on relevant medical device advertising laws and review principles, which are promptly communicated to relevant departments for implementation. For brand product trial articles published by influencers engaged by the brand, the content is reviewed in advance by the Regulatory Affairs Department to ensure compliance with advertising laws.