Post-Market Surveillance. 1. Member States shall establish post market surveillance systems to complement the implementation of the ASEAN Sectoral Mutual Recognition Arrangements and ASEAN Harmonised Regulatory Regimes and/or Directives.
Post-Market Surveillance. Post-market surveillance activities conducted by Telecommunication Certification Body (TCB) in accordance with ISO/IEC 17065 and 47 CFR Section 2.962(g)(2).
Post-Market Surveillance. As a part of the certification of the Product, the Client‘s Product may be selected for market surveillance purpose according to FCC post-market surveillance guidelines. If selected, Client shall cooperate with the INTERTEK TCB representative which requires the TCB to perform post-market surveillance activities based on type testing of products that the TCB has certified. If selected, Client agrees to reimburse INTERTEK for its services in accordance with the current fee schedule and any shipping expenses.
Post-Market Surveillance. Integrator will cooperate with Cisco and Cisco’s applicable authorized representative directly in matters of vigilance and post-market surveillance in accordance with the European Commission Guidelines On A Medical Devices Vigilance System. Integrator will further provide any such technical support on the usage of HealthPresence Products to the End User based on information supplied by Cisco. Integrator reporting should follow the current European Commission Guidelines On A Medical Devices Vigilance System.
Post-Market Surveillance. ASEAN Member States shall ensure that post market surveillance is in place to handle early warning of any adverse events and/or other product safety issues that may occur and shall take appropriate measures to ensure consumer safety.
Post-Market Surveillance. Both OCD and SNBTS shall ensure that the other party is kept informed of any relevant post-production experience relating to the Products which comes to the attention of either party. OCD shall immediately notify SNBTS of any relevant corrective actions or non-conformances relating to the Products. Both SNBTS and OCD shall adopt and operate appropriate systematic procedures to record and review post-marketing experiences with the Products and such as to comply with all legal requirements.
Post-Market Surveillance. Post-market surveillance will be investigated through complaint history, surgeon feedback, and/or clinical evaluations of both WMT and related competitor products.
Post-Market Surveillance. Member States shall ensure that post market surveillance is in place to handleearly warning of any adverse events and/or other product safety issues that may occur and shalltake appropriate measures to ensure consumer safety.
Post-Market Surveillance. Certain Regulatory Authorities require a certain percentage of final, market-ready, certified products to be sampled from the finished goods inventory and be examined for compliance. BACL is required to perform this annual Post Market Surveillance Testing (“PMST”) per ISO Guide 65 and each accredited CB Scheme. PMST is used by BACL and each Regulatory Authority to assure that mass produced BACL certified products continue to comply with each Regulatory Authority rules, conditions, terms and BACL requirements. The PMST product sample and test data will be compared to the original product and test data from the BACL certification filing. PMST includes all products that were tested by BACL or other test laboratories, but were certified by BACL. The Applicant understands the need for and agrees to keep some production samples on hand for at least one (1) year after certification is granted and to provide samples when requested to BACL or the Regulatory Authority(s), and at Applicant’s sole expense. A production sample is a mass production sealed certified product from the Applicant’s production line with the User’s Manual, all required Labels and any Product Accessories that were used during the product certification process. The PMST production sample will not be returned to the Applicant unless all costs for packaging and shipping are paid by the Applicant. There are no additional fees payable by the Applicant to BACL for Post Market Surveillance Testing activities. EPA requires 10% of the products certified by BACL in each category and included subtype, each year to be selected for Verification Testing. ACTA requires 2% of the products certified by BACL each year to be selected for PMST. The FCC requires 5% of the products certified by BACL each year with an additional 1% for SAR to be selected for PMST. IC requires 5% of the products certified by BACL each year to be selected for PMST. XXX, MIC and OFTA have not stated their requirements, so BACL shall perform 2% of the products certified by BACL each year to be selected for PMST. The Applicant must provide timely corrective actions to BACL if their PMST production sample does not meet the BACL or Regulatory Authority requirements they met initially.
Post-Market Surveillance. With respect to Guidant's distribution of the Products under this Agreement, Guidant agrees to comply with the United States Food and Drug Administration regulations as outlined in Exhibit B attached hereto.
