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The S&C Portal
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The S&C Portal
The Standards and Conformance (S&C) Portal is an online facility that offers an easy access to a wide range of information on standards, regulations and conformity assessment activities in the Philippines and other WTO member countries.
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Why Use the S&C Portal?
It facilitates a fast, efficient and cost-effective way of obtaining extensive information on standards, conformity assessment requirements, and other trade-related technical regulations/laws;
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Who's Behind the S&C Portal?
The S&C Portal is administered by the Department of Trade and Industry's Bureau of Product Standards (DTI-BPS), which is the National Standards Body of the Philippines and the WTO TBT Enquiry Point of the country.  
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DTI approves International Standard to protect patients against poor and faulty medical devices

DTI approves International Standard to protect patients against poor and faulty medical devices

The Department of Trade and Industry’s Bureau of Philippine Standards (DTI-BPS) approved the International Organization for Standardization (ISO) Standard on clinical investigation of medical devices, as a Philippine National Standard (PNS/ISO 14155:2018).

The PNS ISO 14155:2018 specifies general requirements intended to protect the rights, safety and well-being of human subjects, ensure the scientific conduct of the clinical investigation and the credibility of the results, define the responsibilities of the sponsor and principal investigator, and assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.

Further, the PNS ISO 14155:2018 addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out on human subjects to assess the safety or performance of medical devices for regulatory and other purposes.

“This standard will help assess the safety and performance of medical devices and so improve the protection of patients, provide a technical basis for regulation and minimize technical barriers to trade.” DTI-BPS Director James E. Empeño stresses.

The DTI-BPS is the National Standards Body of the Philippines. It is the Philippines’ member to the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC).

The PNS ISO 14155:2018 is available for purchase at the DTI-BPS’ SDC, located at the DTI Main Office, 3F Trade and Industry Building, 361 Sen. Gil Puyat Avenue, Makati City. To purchase, clients may download the PNS Request Form from the DTI-BPS website, http://www.bps.dti.gov.ph, fill up the form and present it to the BPS-SDC for processing and payment.

For more information, please call the DTI-BPS SDC at (02) 791.3127 or 507.7307 or e-mail through This e-mail address is being protected from spambots. You need JavaScript enabled to view it .

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Department of Trade and Industry - Bureau of Philippine Standards 3/F Trade and Industry Building
361 Sen. Gil Puyat Avenue, Makati City Philippines 1200, Telephone: (632) 751-4700 Fax: (632) 751-4706
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