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Regulatory Product Inspection
Date:2017/10/06

Registration of Product Certification

Introduction of the Measures Governing Registration of Product Certification


In the past forty years, batch-by-batch inspection has been the main conformity assessment procedure used to ensure the compliance of commodities with relevant technical regulations. Along with the development of technical infrastructure which led to advances in the capability of testing and with a view to facilitating trade, we have come to review different approaches that would replace the traditional batch-by-batch inspection.

The preparation of accession to the World Trade Organization is the most important incentive to bring about significant changes to the current certification system. In 1997, the Commodity Inspection Act was revised to include provisions on the use of registration approach to reduce the time needed for customs clearance and to avoid repetitive inspection of products of the same type. Under the new system, which is called "registration of product certification," products are designated to apply the appropriate conformity assessment procedures depending on the nature of risks involved. The new system came into effect in July 1999. At the initial stage of implementation, only industrial products were covered.

The rationale behind the new system is to shift to a more positive way of controlling commodities on the market, to ensure adequate protection of human health and safety, and to reduce the workload of conducting batch-by-batch inspection. Instead of taking preventive measures against fraud or deceptive practices before the products enter the market, the BSMI adopts a less intrusive approach, where post-market surveillance is re-enforced to avoid unnecessary delays that would otherwise delay products from entering the market, such as those resulted from administrative procedures.

Seven modules are designed to take into account the different characteristics of products or product sectors in meeting the regulatory requirements. Similar to the approach taken by the European Union, some of the modules can be applied individually and some must be applied in combination. The seven modules basically cover the design and production phases of products. A product shall be subject to both phases before being allowed to be placed on the market for sale. A brief description of the modules is given in Appendix A and the relationship among them is illustrated in Appendix B. Appendix C shows the specific tasks/responsibilities of the manufacturer, the BSMI, and the customs at different stages of the new system.

The immediate benefits that the new system brings to the manufacturer are reduction of cost and control over the time the products are placed on the market. Instead of going through the complicated and time-consuming batch-by-batch inspection procedures, the conformity assessment procedures can be completed at the design stage, when the products have not gone into mass-production and improvements can still be made to ensure compliance with mandatory safety requirements. This not only saves the manufacturer the cost for correcting non-conformities found after the products are mass-produced but also reduces the resources and work force that the government would have spent on conducting a batch-by-batch inspection. For products that are technologically sensitive and bearing a short life cycle, such as information technology products, the manufacturer has more control over the products' marketing without having to wait for the inspection results after the products having crossed the border.

To further facilitate trade, the BSMI has been exploring the opportunities for establishing cooperative relationships with organizations in other countries in the regulatory field. In comparison with the old system, the new system is more compatible with the one that is widely adopted by most countries and provides further flexibility in negotiating mutual recognition agreements with other countries.

Although the BSMI still retains the right of granting registration, manufacturers abroad may have their products locally type-tested by laboratories and quality systems locally assessed by certification bodies both recognized by the BSMI via the mutual recognition arrangements achieved with the BSMI. The Arrangement that Taiwan signed with New Zealand would serve this purpose to benefit manufacturers in both countries. Alternatively, the BSMI also adopted procedures to recognize testing laboratories and quality management system certification bodies for the use by manufacturers to apply for RPC Mark. Lists of such testing laboratories or certification bodies are provided below.

Lists of Designated Testing Laboratories
Lists of Recognized Management Systems Certification Bodies
Directions for Recognizing Quality Management Systems Certification Bodies(pdf)
List of Domestic Quality Management Systems (QMS) Certification Bodies (CBs) Recognized by the BSMI(pdf)
List of Foreign Quality Management Systems (QMS) Certification Bodies (CBs) Recognized by the BSMI(pdf)
Checklist for Assessment/Surveillance of Production Premises(pdf)
Application Form for Quality Management System Certification Bodies to be recognized by the BSMI
Letter of Authorization for Quality Management System Certification Bodies Applying for Recognition by the BSMI

Brief description of modules under the Registration of Product Certification System

Module I (internal-control): this module applies to products of simple design with less safety concerns. The manufacturer or the authorized local representative (if the manufacturer is located abroad) shall file an application for registration together with a declaration of conformity indicating compliance of the product concerned with specified standards or technical specifications.

Module II (type-test): this module generally applies to products of fixed construction and mass production. The manufacturer or the authorized local representative shall apply to the designated body together with a specimen of the product concerned for the conduction of necessary tests against specified standards or technical specifications. Where the specimen meets relevant requirements, the designated body shall issue a type-test report to the applicant. This module has to be used in combination with other modules.

Module III (conformity-to-type declaration): a declaration of conformity to type shall be drawn up by the manufacturer or the authorized local representative, declaring that the products concerned comply with the type as described in the type-test report.

Module IV (full quality assurance): the manufacturer must establish a quality system that is in compliance with CNS 12680 (ISO 9000) series of standards and certified by the BSMI or its recognized certification bodies via appropriate assessments.

Module V (production quality assurance): the manufacturer must establish a quality system that is in compliance with CNS 12680 (ISO 9000) series of standards and certified by the BSMI or its recognized certification bodies via appropriate assessments.

Module VI (product quality assurance): the manufacturers must establish a quality system that is in compliance with CNS 12680 (ISO 9000) series of standards and certified by the BSMI or its recognized certification bodies via appropriate assessment activities.

Module VII (simplified quality assurance): this module is specifically designed to suit the needs of small-sized manufacturers, mainly home-based and unique to our society in the course of economic development, where only minimum quality elements are required to ensure the compliance of the products with relevant requirements. The BSMI will also identify the quality elements with which the manufacturer must comply when this module is designated. Assessment shall be conducted by the BSMI.
Among the above modules, Module I can be applied alone while Modules III, IV, V, VI, VII must be applied in combination with Module II respectively.

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