Product Safety and Marketing Labels

Product Safety and Marketing Labels

 

All medical device products sold by BenQ Materials must obtain regulatory approval and certification from the respective countries prior to market entry. Certifications acquired include those from Taiwan (TFDA), the European Union (CE), the United States (FDA), and China (NMPA).

During clinical trials, products must comply with ISO 14971:2019, the standard for medical device risk management, and ISO 14155:2020, the guideline for clinical evaluation of medical devices. These standards govern risk management during product development and the scientific design, execution, documentation, and reporting of clinical trials to ensure reliable and valid results. In addition, medical devices intended for direct human contact must pass biocompatibility testing under the ISO 10993 series before market release.

Countries	Applicable Product Regulations
Malaysia	Laws of Malaysia Act 737 Medical Device Act 2012
Thailand	Medical Device Act, B.E. 2551 (2008)
Indonesia	Law on Health (Law No. 36/2009) Permenkes No. 62 Year 2017
Vietnam	DECREE on Medical Equipment Management DECREE on Amendments to the Government’s Decree 36/2016/ND-CP dated May 15, 2016 on Medical Equipment Management CIRCULAR on Recognition of Medical Device Classification Results CIRCULAR on Classification of Medical Device
Philippines	Republic Act No. 9711.《AN ACT STRENGTHENING AND RATIONALIZING THE REGULATORY CAPACITY OF THE BUREAU OF FOOD AND DRUGS (BFAD) BY ESTABLISHING ADEQUATE TESTING LABORATORIES AND FIELD OFFICES, UPGRADING ITS EQUIPMENT, AUGMENTING ITS HUMAN RESOURCE COMPLEMENT, GIVING AUTHORITY TO RETAIN ITS INCOME, RENAMING IT THE FOOD AND DRUG ADMINISTRATION (FDA), AMENDING CERTAIN SECTIONS OF REPUBLIC ACT NO. 3720, AS AMENDED, AND APPROPRIATING FUNDS THEREOF.》 Republic Act No. 3720.《AN ACT TO ENSURE THE SAFETY AND PURITY OF FOODS, DRUGS, AND COSMETICS BEING MADE AVAILABLE TO THE PUBLIC BY CREATING THE FOOD AND DRUG ADMINISTRATION WHICH SHALL ADMINISTER AND ENFORCE THE LAWS PERTAINING THERETO.》
Spain	MDR

 

Medical Device Manufacturing and Sales Permits

BenQ Materials is a licensed medical device manufacturer, having obtained official approval and registration to produce related medical device products. These products comply with the safety and manufacturing standards of various countries, and the company holds all necessary manufacturing licenses.

For product sales, BenQ Materials must also acquire a medical device distribution license and complete product registration before any product can be legally marketed. Additionally, since contact lenses are classified as medical devices, they must be sold through physical retail channels that hold valid medical device distribution licenses before reaching end consumers.

 

Medical Device Product Labeling and Marketing Regulations

Transport Packaging Labeling Requirements

• Outer Packaging: Must be clear, easily identifiable, and permanent, including the following details:

• Product catalog number
• Quantity
• Manufacturer or supplier name/logo
• Production date in ISO 8601 format
• Batch/lot number
• Basis weight (grams per square meter)
• Roll width (cm) and length (m)
• Recommended storage conditions

• Inner Packaging or Roll Labels: Must be clearly visible and firmly attached, including:

• Quantity
• Manufacturer or supplier name/logo
• Batch number
• Basis weight (grams per square meter)

 

Medical Device Labeling Requirements

All BenQ Materials' medical device labels must comply with the local medical device regulations of each target sales market. In addition, labeling follows ISO 15223-1:2021, which provides standardized symbols for labeling and product information used in medical devices.

For products governed under Taiwan's Medical Devices Act, labels, instructions, or packaging must include:
• Product name
• License number or registration number
• Performance/intended use or indications
• Manufacturing date and expiration/shelf life
• Model/specification or key components
• Warnings, precautions, usage limitations, and foreseeable side effects
• Name and address of the license holder or registrant
• Name and address of the manufacturer
• Lot number or serial number
• Any other items announced by the central competent authority

 

Medical Device Marketing Requirements

Marketing of medical devices must strictly comply with the relevant advertising and marketing laws in each jurisdiction.
For example, in Taiwan:
• Pre-approval is required from competent authorities for any promotional materials, including text, graphics, or verbal content.
• Promotional practices are restricted: it is prohibited to advertise through impersonation, disguised publications, interviews, or other improper methods.

Taking contact lenses as an example (regulated as medical devices), all advertisements— whether print or digital—must comply with Taiwan FDA advertising review guidelines. The Ministry of Health and Welfare regularly communicates updated rules and review principles to ensure proper implementation.

For influencer collaborations, BenQ Materials requires all branded product review content to be pre-screened by the regulatory affairs department to ensure compliance with advertising laws.