{"id":315,"date":"2024-02-01T21:47:15","date_gmt":"2024-02-01T21:47:15","guid":{"rendered":"https:\/\/ssmk-moscow.cn\/en\/?page_id=315"},"modified":"2024-02-22T16:28:22","modified_gmt":"2024-02-22T16:28:22","slug":"making-changes-to-the-registration-dossier","status":"publish","type":"page","link":"https:\/\/ssmk-moscow.cn\/en\/making-changes-to-the-registration-dossier\/","title":{"rendered":"Making changes to the registration dossier"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; next_background_color=&#8221;#f9f9f9&#8243; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; background_color=&#8221;rgba(46,58,71,0.64)&#8221; background_image=&#8221;https:\/\/ssmk-moscow.cn\/en\/wp-content\/uploads\/sites\/2\/2024\/02\/services-bg.webp&#8221; background_position=&#8221;top_center&#8221; background_blend=&#8221;overlay&#8221; background_enable_pattern_style=&#8221;on&#8221; background_pattern_style=&#8221;honeycomb&#8221; background_pattern_color=&#8221;rgba(0,0,0,0.04)&#8221; width=&#8221;100%&#8221; module_alignment=&#8221;center&#8221; custom_padding=&#8221;80px||80px||true|false&#8221; bottom_divider_style=&#8221;curve&#8221; bottom_divider_height=&#8221;50px&#8221; bottom_divider_height_tablet=&#8221;50px&#8221; bottom_divider_height_phone=&#8221;20px&#8221; bottom_divider_height_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; max_width=&#8221;100%&#8221; module_alignment=&#8221;center&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_divider divider_weight=&#8221;6px&#8221; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; width=&#8221;132px&#8221; module_alignment=&#8221;center&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_divider][et_pb_text _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; text_text_color=&#8221;#FFFFFF&#8221; text_font_size=&#8221;20px&#8221; text_line_height=&#8221;1.9em&#8221; header_font=&#8221;|700|||||||&#8221; header_text_align=&#8221;center&#8221; header_text_color=&#8221;#ffffff&#8221; header_line_height=&#8221;1.3em&#8221; text_orientation=&#8221;center&#8221; custom_margin=&#8221;-10px|||||&#8221; text_font_size_tablet=&#8221;&#8221; text_font_size_phone=&#8221;14px&#8221; text_font_size_last_edited=&#8221;on|phone&#8221; header_font_size_tablet=&#8221;&#8221; header_font_size_phone=&#8221;25px&#8221; header_font_size_last_edited=&#8221;on|phone&#8221; header_line_height_tablet=&#8221;&#8221; header_line_height_phone=&#8221;1.4em&#8221; header_line_height_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h1>Making changes to the registration dossier<\/h1>\n<p>Adhering to the regulations in Government Resolution No. 1416, we specialize in updating manufacturer information, including legal entity changes, name alterations, and address modifications. This ensures that all registered details accurately reflect the current status of the medical device manufacturer, maintaining compliance with state registration rules.[\/et_pb_text][et_pb_divider divider_weight=&#8221;6px&#8221; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; width=&#8221;132px&#8221; module_alignment=&#8221;center&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_divider][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; background_color=&#8221;#f9f9f9&#8243; custom_padding=&#8221;80px||80px|||&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row column_structure=&#8221;1_4,3_4&#8243; use_custom_gutter=&#8221;on&#8221; gutter_width=&#8221;2&#8243; make_equal=&#8221;on&#8221; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; max_width=&#8221;100%&#8221; custom_padding=&#8221;0px||0px|||&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_4&#8243; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; background_color=&#8221;#d2a343&#8243; link_option_url_new_window=&#8221;on&#8221; custom_css_main_element=&#8221;display: flex;||flex-direction: column;||justify-content: center;&#8221; border_radii=&#8221;off||||&#8221; border_color_all=&#8221;#e5e5e5&#8243; box_shadow_style=&#8221;preset1&#8243; box_shadow_vertical=&#8221;0px&#8221; box_shadow_blur=&#8221;0px&#8221; global_colors_info=&#8221;{}&#8221; box_shadow_vertical__hover_enabled=&#8221;on|hover&#8221; box_shadow_vertical__hover=&#8221;2px&#8221; box_shadow_blur__hover_enabled=&#8221;on|hover&#8221; box_shadow_blur__hover=&#8221;18px&#8221;][et_pb_text _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; text_text_color=&#8221;#FFFFFF&#8221; text_font_size=&#8221;18px&#8221; header_font=&#8221;|||on|||||&#8221; header_text_color=&#8221;#FFFFFF&#8221; header_font_size=&#8221;40px&#8221; header_2_text_color=&#8221;#FFFFFF&#8221; header_2_font_size=&#8221;25px&#8221; header_2_line_height=&#8221;1.3em&#8221; custom_padding=&#8221;|30px||30px|false|true&#8221; custom_padding_tablet=&#8221;40px|30px|40px|30px|true|true&#8221; custom_padding_phone=&#8221;40px|30px|40px|30px|true|true&#8221; custom_padding_last_edited=&#8221;on|phone&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h2><span>Guiding Registration Dossier Amendments<\/span><\/h2>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;3_4&#8243; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; link_option_url_new_window=&#8221;on&#8221; border_color_all=&#8221;#e5e5e5&#8243; global_colors_info=&#8221;{}&#8221; box_shadow_vertical__hover=&#8221;2px&#8221; box_shadow_vertical__hover_enabled=&#8221;on|hover&#8221; box_shadow_blur__hover=&#8221;18px&#8221; box_shadow_blur__hover_enabled=&#8221;on|hover&#8221;][et_pb_text ul_type=&#8221;square&#8221; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; ul_text_color=&#8221;#d2a343&#8243; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h3><span data-preserver-spaces=\"true\">Modifying the Registration <strong>Certificate<\/strong><\/span><\/h3>\n<p><span data-preserver-spaces=\"true\">The amendment process for registration documents\u00a0 follows paragraph 55 of the Russian Federation&#8217;s Government Decree No. 1416, dated December 27, 2012, endorsing the Medical Devices State Registration Rules.<\/span><\/p>\n<p><span data-preserver-spaces=\"true\">When changes are needed (as requested by the applicant) to documents referred to in subparagraph &#8220;a&#8221; of paragraph 54, the applicant must submit a change request along with supporting documents to the registration authority.<\/span><\/p>\n<p><strong>If changes to documents outlined in Rule 10 sub-paragraphs are required:<\/strong><\/p>\n<ul>\n<li><span data-preserver-spaces=\"true\">&#8220;<span style=\"color: #000000;\">c&#8221; the manufacturer&#8217;s technical documentation for the medical device,<\/span><\/span><\/li>\n<li><span data-preserver-spaces=\"true\" style=\"color: #000000;\">&#8220;d&#8221; the manufacturer&#8217;s operational documentation, including the user manual or operating instructions for the medical device,<\/span><\/li>\n<li><span data-preserver-spaces=\"true\" style=\"color: #000000;\">these changes are subject to an evaluative process similar to that used for the medical device&#8217;s state registration quality, efficacy, and safety assessment, in line with paragraph 21 of the Rules.<\/span><\/li>\n<\/ul>\n<p><span data-preserver-spaces=\"true\">Changes are permissible only if they do not alter the properties and characteristics affecting the medical device&#8217;s quality, efficacy, and safety, or if they enhance these properties without changing the device&#8217;s functional purpose or operating principle.<\/span><\/p>\n<p><strong>Should the revisions to the technical and\/or operational documentation pertain to:<\/strong><\/p>\n<ul>\n<li><span data-preserver-spaces=\"true\" style=\"color: #000000;\">extending or removing the expiry date of the technical specifications for the medical device,<\/span><\/li>\n<li><span data-preserver-spaces=\"true\" style=\"color: #000000;\">altering the labeling or packaging of the medical device,<\/span><\/li>\n<li><span data-preserver-spaces=\"true\" style=\"color: #000000;\">updating information about the authorized representative of the medical device&#8217;s manufacturer,<\/span><\/li>\n<li><span data-preserver-spaces=\"true\" style=\"color: #000000;\">refreshing documents in the registration Certificate (like ISO certificates, and manufacturer&#8217;s authorizations),<\/span><\/li>\n<\/ul>\n<p><span data-preserver-spaces=\"true\">The Roszdravnadzor has the authority to approve these amendments independently, without the aforementioned assessment.<\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; prev_background_color=&#8221;#f9f9f9&#8243; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; background_color=&#8221;#f2f2f2&#8243; custom_padding=&#8221;80px||80px|||&#8221; top_divider_style=&#8221;arrow3&#8243; top_divider_height=&#8221;50px&#8221; top_divider_flip=&#8221;vertical&#8221; bottom_divider_style=&#8221;arrow3&#8243; bottom_divider_color=&#8221;#FFFFFF&#8221; bottom_divider_height=&#8221;50px&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row column_structure=&#8221;1_2,1_2&#8243; use_custom_gutter=&#8221;on&#8221; gutter_width=&#8221;1&#8243; make_equal=&#8221;on&#8221; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; max_width=&#8221;100%&#8221; custom_margin=&#8221;1px|auto||auto|false|false&#8221; custom_padding=&#8221;0px||0px|||&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;|5%||5%|false|true&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text ul_type=&#8221;square&#8221; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; ul_text_color=&#8221;#d2a343&#8243; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p><strong>Documents needed for changes due to the technical conditions, authorizations (contracts), and certificates (such as ISO 13485, 9001) expiring:<\/strong><\/p>\n<p><strong><\/strong><\/p>\n<ul>\n<li><span style=\"color: #000000;\">A statement on the introduction of amendments to documents as provided for in paragraph 10 of the Rules. <\/span><\/li>\n<li><span style=\"color: #000000;\">Updated documents (for example, specifications and notification of changes to specifications) <\/span><\/li>\n<li><span style=\"color: #000000;\">In the case of a foreign manufacturer &#8211; a power of attorney for the authorized representative of the manufacturer.<\/span><\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;|5%||5%|false|true&#8221; border_width_left=&#8221;4px&#8221; border_color_left=&#8221;#d2a343&#8243; global_colors_info=&#8221;{}&#8221;][et_pb_text ul_type=&#8221;square&#8221; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; ul_text_color=&#8221;#d2a343&#8243; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p><strong>Documents Required for Revisions in Response to Updates in Regulatory Documents or National (International) Standards that Govern the Manufacturing and Utilization of the Medical Device:<\/strong><\/p>\n<p><strong><\/strong><\/p>\n<ul>\n<li><span style=\"color: #000000;\">A statement regarding the revision of documents as stipulated in Section 10 of the Policies. <\/span><\/li>\n<li><span style=\"color: #000000;\">The manufacturer&#8217;s technical and operational documentation, citing the updated documents that govern the production and use of the medical device (such as technical specifications and notices of technical specification amendments, identification documents, user manuals, etc.) <\/span><\/li>\n<li><span style=\"color: #000000;\">For foreign manufacturers &#8211; a power of attorney to the manufacturer&#8217;s designated representative <\/span><\/li>\n<li><span style=\"color: #000000;\">Protocols of required tests that verify the implemented changes and are in accordance with the Russian Ministry of Health&#8217;s Order No. 2n dated January 9, 2014.<\/span><\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_2,1_2&#8243; use_custom_gutter=&#8221;on&#8221; gutter_width=&#8221;1&#8243; make_equal=&#8221;on&#8221; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; max_width=&#8221;100%&#8221; custom_margin=&#8221;|auto||auto|false|false&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;|5%||5%|false|true&#8221; border_color_left=&#8221;#d2a343&#8243; global_colors_info=&#8221;{}&#8221;][et_pb_text ul_type=&#8221;square&#8221; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; ul_text_color=&#8221;#d2a343&#8243; custom_margin=&#8221;||||false|false&#8221; custom_padding=&#8221;35px||||false|false&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p><strong>Required Documentation for Modifications Due to Changes in the Labeling or Packaging of a Medical Device:<\/strong><\/p>\n<p><strong><\/strong><\/p>\n<ul>\n<li><span style=\"color: #000000;\">A statement on the amendments to the documents as stipulated in paragraph 10 of the Rules. <\/span><\/li>\n<li><span style=\"color: #000000;\">All documents containing information about the labeling or packaging of a medical device (for example, technical specifications and notification of changes to technical specifications) <\/span><\/li>\n<li><span style=\"color: #000000;\">Photographic images of the labeling layout <\/span><\/li>\n<li><span style=\"color: #000000;\">In the case of a foreign manufacturer &#8211; a power of attorney for the authorized representative of the manufacturer <\/span><\/li>\n<li><span style=\"color: #000000;\">Documents confirming the rights to use an additional service mark<\/span><\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;|5%||5%|false|true&#8221; border_width_left=&#8221;4px&#8221; border_color_left=&#8221;#d2a343&#8243; global_colors_info=&#8221;{}&#8221;][et_pb_text ul_type=&#8221;square&#8221; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; ul_text_color=&#8221;#d2a343&#8243; custom_margin=&#8221;||||false|false&#8221; custom_padding=&#8221;35px||||false|false&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p><strong>Documents Required for Updates Following Changes in Storage Duration, Expiration Dates, or Manufacturer&#8217;s Warranty Periods, as well as Changes in Information Regarding Maintenance, Repair, Disposal, or Destruction of the Medical Device:<\/strong><\/p>\n<p><strong><\/strong><\/p>\n<ul>\n<li><span style=\"color: #000000;\">A statement on the introduction of changes in documents, as envisaged by paragraph 10 of the Rules.<\/span><\/li>\n<li><span style=\"color: #000000;\">Documents containing information on new storage terms, shelf life, or terms of manufacturer&#8217;s warranty obligations, as well as details on the new procedure for technical maintenance, repair, disposal, or destruction of a medical device (for example, technical specifications and notification of changes to technical specifications, passport, or operating manual, etc.)<\/span><\/li>\n<li><span style=\"color: #000000;\">Protocols of necessary tests, confirming the changes made and in accordance with the order of the Ministry of Health of Russia dated 09.01.2014 No. 2n<\/span><\/li>\n<li><span style=\"color: #000000;\">In the case of a foreign manufacturer &#8211; a power of attorney for the manufacturer&#8217;s authorized representative<\/span><\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_2,1_2&#8243; use_custom_gutter=&#8221;on&#8221; gutter_width=&#8221;1&#8243; make_equal=&#8221;on&#8221; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; max_width=&#8221;100%&#8221; custom_margin=&#8221;|auto||auto|false|false&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;|5%||5%|false|true&#8221; border_color_left=&#8221;#d2a343&#8243; global_colors_info=&#8221;{}&#8221;][et_pb_text ul_type=&#8221;square&#8221; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; ul_text_color=&#8221;#d2a343&#8243; custom_margin=&#8221;||||false|false&#8221; custom_padding=&#8221;35px||||false|false&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p><strong>Documentation Required for Revisions Due to Changes in the Indications (Contraindications) for Use of the Medical Device or Changes in the Device&#8217;s Scope of Application:<\/strong><\/p>\n<p><strong><\/strong><\/p>\n<ul>\n<li><span style=\"color: #000000;\">A statement detailing the amendments to the documents specified in Section 10 of the Regulations.<\/span><\/li>\n<li><span style=\"color: #000000;\">A document containing information on new indications (contraindications) for the use of a medical device or the scope of application of a medical device, based on which the manufacturer has made the corresponding decision (for example, results of clinical studies) <\/span><\/li>\n<li><span style=\"color: #000000;\">In the case of a foreign manufacturer &#8211; a power of attorney for the manufacturer&#8217;s authorized representative<\/span><\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;|5%||5%|false|true&#8221; border_width_left=&#8221;4px&#8221; border_color_left=&#8221;#d2a343&#8243; global_colors_info=&#8221;{}&#8221;][et_pb_text ul_type=&#8221;square&#8221; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; ul_text_color=&#8221;#d2a343&#8243; custom_margin=&#8221;||||false|false&#8221; custom_padding=&#8221;35px||||false|false&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p><strong>Documents Required for Updates Following Changes in Storage Duration, Expiration Dates, or Manufacturer&#8217;s Warranty Periods, as well as Changes in Information Regarding Maintenance, Repair, Disposal, or Destruction of the Medical Device:<\/strong><\/p>\n<p><strong><\/strong><\/p>\n<ul>\n<li><span style=\"color: #000000;\">A statement regarding the update of documents outlined in Section 10 of the Guidelines. <\/span><\/li>\n<li><span style=\"color: #000000;\">Documentation that includes information on the medical device&#8217;s new features (technical and operational documents). <\/span><\/li>\n<li><span style=\"color: #000000;\">Test protocols that validate the changes made, complying with the Russian Ministry of Health&#8217;s Order No. 2n dated January 9, 2014.<\/span><\/li>\n<li><span style=\"color: #000000;\">In the case of a foreign manufacturer &#8211; a power of attorney for the manufacturer&#8217;s authorized representative<\/span><\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_2,1_2&#8243; use_custom_gutter=&#8221;on&#8221; gutter_width=&#8221;1&#8243; make_equal=&#8221;on&#8221; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; max_width=&#8221;100%&#8221; custom_margin=&#8221;|auto||auto|false|false&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;|5%||5%|false|true&#8221; border_color_left=&#8221;#d2a343&#8243; global_colors_info=&#8221;{}&#8221;][et_pb_text ul_type=&#8221;square&#8221; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; ul_text_color=&#8221;#d2a343&#8243; custom_margin=&#8221;||||false|false&#8221; custom_padding=&#8221;35px||||false|false&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p><strong>Possible Changes Requiring Updates to Technical and Operational Documentation:<\/strong><\/p>\n<p><strong><span style=\"color: #000000;\">Modification of the Product Name<\/span><\/strong><\/p>\n<ul>\n<li><span style=\"color: #000000;\">Details affirming the unchanged functional purpose<\/span><\/li>\n<li><span style=\"color: #000000;\">Consistency or enhancement of properties and characteristics that impact the medical device&#8217;s quality, efficiency, and safety<\/span><\/li>\n<\/ul>\n<p><strong><span style=\"color: #000000;\">Modification of Parameters and Characteristics<\/span><\/strong><\/p>\n<ul>\n<li><span style=\"color: #000000;\">Confirmation of unchanged functional purpose<\/span><\/li>\n<li><span style=\"color: #000000;\">Details on all modified parameters and characteristics<\/span><\/li>\n<li><span style=\"color: #000000;\">Methods for validation of new parameters and characteristics<\/span><\/li>\n<\/ul>\n<p><strong><span style=\"color: #000000;\">Modification of Sterilization Techniques<\/span><\/strong><\/p>\n<ul>\n<li><span style=\"color: #000000;\">Documentation for sterilization process validation<\/span><\/li>\n<li><span style=\"color: #000000;\">Markings on medical devices provided in a sterile condition<\/span><\/li>\n<\/ul>\n<p><strong><span style=\"color: #000000;\">Modification of Reliability Features<\/span><\/strong><\/p>\n<ul>\n<li><span style=\"color: #000000;\">Data on shelf life and storage timeframes<\/span><\/li>\n<li><span style=\"color: #000000;\">Service life information<\/span><\/li>\n<li><span style=\"color: #000000;\">Warranty term specifics<\/span><\/li>\n<\/ul>\n<p><strong><span style=\"color: #000000;\">Modification of Additional Information on the Medical Device<\/span><\/strong><\/p>\n<ul>\n<li><span style=\"color: #000000;\">Procedures for disposal<\/span><\/li>\n<li><span style=\"color: #000000;\">Logistics and storage information<\/span><\/li>\n<\/ul>\n<p><strong><span style=\"color: #000000;\">Renewal of Time-Sensitive Documents<\/span><\/strong><\/p>\n<ul>\n<li><span style=\"color: #000000;\">Technical documents and quality management system certifications<\/span><\/li>\n<li><span style=\"color: #000000;\">Other time-sensitive documents<\/span><\/li>\n<\/ul>\n<p><span style=\"color: #000000;\"><\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; 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