Skip to content

Commit 5e426b9

Browse files
NarlaiNarlai
committed
bugs fix
1 parent d234aef commit 5e426b9

61 files changed

Lines changed: 785 additions & 1 deletion

File tree

Some content is hidden

Large Commits have some content hidden by default. Use the searchbox below for content that may be hidden.

‎sites/br/sidebars.ts‎

Lines changed: 320 additions & 1 deletion
Original file line numberDiff line numberDiff line change
@@ -1,5 +1,324 @@
11
import type { SidebarsConfig } from '@docusaurus/plugin-content-docs';
22
const sidebars: SidebarsConfig = {
3-
regulationSidebar: [{ type: 'autogenerated', dirName: '.' }],
3+
regulationSidebar: ['intro',
4+
{
5+
type: 'category',
6+
label: 'Start Here',
7+
link: { type: 'doc', id: 'start-here/what-is-a-medical-device' },
8+
items: [
9+
'start-here/what-is-a-medical-device',
10+
'start-here/what-is-an-ivd',
11+
'start-here/what-is-not-a-medical-device',
12+
'start-here/borderline-products',
13+
'start-here/regulatory-framework',
14+
'start-here/anvisa-overview',
15+
'start-here/snvs-overview',
16+
'start-here/state-visa-bodies',
17+
'start-here/key-roles',
18+
'start-here/device-lifecycle',
19+
'start-here/mercosul-alignment',
20+
'start-here/glossary',
21+
],
22+
},
23+
{
24+
type: 'category',
25+
label: 'Pre-Market',
26+
link: { type: 'doc', id: 'pre-market/classification/how-classification-works' },
27+
items: [
28+
{
29+
type: 'category',
30+
label: 'Classification',
31+
link: { type: 'doc', id: 'pre-market/classification/how-classification-works' },
32+
items: [
33+
'pre-market/classification/how-classification-works',
34+
'pre-market/classification/class-i-ii-iii-iv',
35+
'pre-market/classification/classification-rules',
36+
'pre-market/classification/ivd-classification',
37+
'pre-market/classification/samd-classification',
38+
'pre-market/classification/borderline-combination',
39+
'pre-market/classification/mercosul-classification',
40+
],
41+
},
42+
{
43+
type: 'category',
44+
label: 'Registration Pathway',
45+
link: { type: 'doc', id: 'pre-market/registration/notificacao-cadastro-registro' },
46+
items: [
47+
'pre-market/registration/notificacao-cadastro-registro',
48+
'pre-market/registration/notificacao',
49+
'pre-market/registration/cadastro',
50+
'pre-market/registration/registro',
51+
'pre-market/registration/ivd-registration',
52+
'pre-market/registration/peticionamento-eletronico',
53+
'pre-market/registration/technical-file',
54+
'pre-market/registration/registration-validity',
55+
'pre-market/registration/post-registration-changes',
56+
'pre-market/registration/review-process',
57+
],
58+
},
59+
{
60+
type: 'category',
61+
label: 'Technical Documentation',
62+
link: { type: 'doc', id: 'pre-market/technical-documentation/device-description' },
63+
items: [
64+
'pre-market/technical-documentation/device-description',
65+
'pre-market/technical-documentation/essential-requirements',
66+
'pre-market/technical-documentation/risk-management',
67+
'pre-market/technical-documentation/biocompatibility',
68+
'pre-market/technical-documentation/electrical-safety-emc',
69+
'pre-market/technical-documentation/sterilisation',
70+
'pre-market/technical-documentation/software-documentation',
71+
],
72+
},
73+
{
74+
type: 'category',
75+
label: 'Clinical Evidence',
76+
link: { type: 'doc', id: 'pre-market/clinical-evidence/overview' },
77+
items: [
78+
'pre-market/clinical-evidence/overview',
79+
'pre-market/clinical-evidence/clinical-investigations',
80+
'pre-market/clinical-evidence/ethics-approval',
81+
'pre-market/clinical-evidence/substantial-equivalence',
82+
'pre-market/clinical-evidence/foreign-clinical-data',
83+
'pre-market/clinical-evidence/ivd-performance-studies',
84+
],
85+
},
86+
{
87+
type: 'category',
88+
label: 'Special Device Types',
89+
link: { type: 'doc', id: 'pre-market/special-device-types/software-samd' },
90+
items: [
91+
'pre-market/special-device-types/software-samd',
92+
'pre-market/special-device-types/implantable-devices',
93+
'pre-market/special-device-types/active-devices-inmetro',
94+
'pre-market/special-device-types/radiation-emitting',
95+
'pre-market/special-device-types/combination-products',
96+
'pre-market/special-device-types/single-use-devices',
97+
'pre-market/special-device-types/custom-devices',
98+
'pre-market/special-device-types/point-of-care-ivds',
99+
'pre-market/special-device-types/companion-diagnostics',
100+
'pre-market/special-device-types/systems-kits',
101+
'pre-market/special-device-types/exported-devices',
102+
],
103+
},
104+
],
105+
},
106+
{
107+
type: 'category',
108+
label: 'Post-Market',
109+
link: { type: 'doc', id: 'post-market/overview' },
110+
items: [
111+
'post-market/overview',
112+
{
113+
type: 'category',
114+
label: 'Adverse Event Reporting',
115+
link: { type: 'doc', id: 'post-market/adverse-events/what-must-be-reported' },
116+
items: [
117+
'post-market/adverse-events/what-must-be-reported',
118+
'post-market/adverse-events/reporting-timeframes',
119+
'post-market/adverse-events/notivisa',
120+
'post-market/adverse-events/annual-report',
121+
'post-market/adverse-events/healthcare-facility-reporting',
122+
'post-market/adverse-events/complaints-vs-adverse-events',
123+
],
124+
},
125+
{
126+
type: 'category',
127+
label: 'Post-Market Surveillance',
128+
link: { type: 'doc', id: 'post-market/pms/pms-plan' },
129+
items: [
130+
'post-market/pms/pms-plan',
131+
'post-market/pms/complaint-handling',
132+
'post-market/pms/pms-report',
133+
'post-market/pms/pmcf',
134+
'post-market/pms/ivd-pmpf',
135+
'post-market/pms/distribution-records',
136+
],
137+
},
138+
{
139+
type: 'category',
140+
label: 'Recalls & Field Safety Actions',
141+
link: { type: 'doc', id: 'post-market/recalls/when-required' },
142+
items: [
143+
'post-market/recalls/when-required',
144+
'post-market/recalls/recall-classifications',
145+
'post-market/recalls/field-safety-actions',
146+
'post-market/recalls/anvisa-mandatory-recall',
147+
'post-market/recalls/interdicao-apprehension',
148+
],
149+
},
150+
{
151+
type: 'category',
152+
label: 'Labelling & IFU',
153+
link: { type: 'doc', id: 'post-market/labelling/requirements' },
154+
items: [
155+
'post-market/labelling/requirements',
156+
'post-market/labelling/portuguese-language',
157+
'post-market/labelling/electronic-ifu',
158+
'post-market/labelling/inmetro-marks',
159+
'post-market/labelling/advertising-claims',
160+
'post-market/labelling/expiry-lot-number',
161+
],
162+
},
163+
{
164+
type: 'category',
165+
label: 'Establishment Authorisation',
166+
link: { type: 'doc', id: 'post-market/establishment/afe' },
167+
items: [
168+
'post-market/establishment/afe',
169+
'post-market/establishment/afe-types',
170+
'post-market/establishment/licenca-funcionamento',
171+
'post-market/establishment/cnpj-anvisa-registration',
172+
],
173+
},
174+
],
175+
},
176+
{
177+
type: 'category',
178+
label: 'GMP & Quality System (CBPF)',
179+
link: { type: 'doc', id: 'gmp/overview' },
180+
items: [
181+
'gmp/overview',
182+
'gmp/cbpf-vs-iso13485',
183+
'gmp/gmp-manufacturers',
184+
'gmp/gmp-importers',
185+
'gmp/management-responsibility',
186+
'gmp/document-control',
187+
'gmp/design-development',
188+
'gmp/purchasing-controls',
189+
'gmp/production-controls',
190+
'gmp/sterilisation-controls',
191+
'gmp/capa',
192+
'gmp/internal-audit',
193+
'gmp/complaint-handling',
194+
'gmp/inspections',
195+
'gmp/auto-declaracao',
196+
'gmp/cbpf-certificate',
197+
'gmp/penalties',
198+
],
199+
},
200+
{
201+
type: 'category',
202+
label: 'Importers, Distributors & Traceability',
203+
link: { type: 'doc', id: 'importers-distributors/importer-role' },
204+
items: [
205+
'importers-distributors/importer-role',
206+
'importers-distributors/afe-importers',
207+
'importers-distributors/responsavel-tecnico',
208+
'importers-distributors/import-documentation',
209+
'importers-distributors/siscomex-customs',
210+
'importers-distributors/ncm-codes',
211+
'importers-distributors/foreign-manufacturer-certificate',
212+
'importers-distributors/gmp-equivalence',
213+
'importers-distributors/distributor-requirements',
214+
'importers-distributors/storage-transport',
215+
'importers-distributors/distributor-recall-reporting',
216+
'importers-distributors/traceability-overview',
217+
'importers-distributors/udi-alignment',
218+
'importers-distributors/lot-serial-number',
219+
'importers-distributors/implant-records',
220+
'importers-distributors/snvs-traceability',
221+
],
222+
},
223+
{
224+
type: 'category',
225+
label: 'Legislation & Regulations',
226+
link: { type: 'doc', id: 'legislation/primary-legislation' },
227+
items: [
228+
'legislation/primary-legislation',
229+
'legislation/rdc-751-2022',
230+
'legislation/rdc-752-2022',
231+
'legislation/rdc-753-2022',
232+
'legislation/rdc-754-2022',
233+
'legislation/rdc-755-2022',
234+
'legislation/rdc-10-2015',
235+
'legislation/rdc-36-2015',
236+
'legislation/normative-instructions',
237+
'legislation/mercosul-resolutions',
238+
'legislation/abnt-standards',
239+
'legislation/how-to-read-rdcs',
240+
'legislation/recent-amendments',
241+
],
242+
},
243+
{
244+
type: 'category',
245+
label: 'Guidance Documents',
246+
link: { type: 'doc', id: 'guidance/by-topic' },
247+
items: [
248+
'guidance/by-topic',
249+
'guidance/by-device-type',
250+
'guidance/notas-tecnicas',
251+
'guidance/perguntas-respostas',
252+
'guidance/peticionamento-guides',
253+
'guidance/forms-templates',
254+
'guidance/audiencias-publicas',
255+
],
256+
},
257+
{
258+
type: 'category',
259+
label: 'Special Access & Programmes',
260+
link: { type: 'doc', id: 'special-access/uso-compassivo' },
261+
items: [
262+
'special-access/uso-compassivo',
263+
'special-access/acesso-ampliado',
264+
'special-access/medida-cautelar',
265+
'special-access/bndes-finep',
266+
'special-access/pdp',
267+
'special-access/industry-associations',
268+
],
269+
},
270+
{
271+
type: 'category',
272+
label: 'International & Comparison',
273+
link: { type: 'doc', id: 'international/overview' },
274+
items: [
275+
'international/overview',
276+
'international/imdrf-alignment',
277+
'international/anvisa-vs-others',
278+
'international/cfg-free-sale-certificate',
279+
'international/multi-market-strategy',
280+
'international/mercosul-roadmap',
281+
],
282+
},
283+
{
284+
type: 'category',
285+
label: 'Enforcement & Compliance',
286+
link: { type: 'doc', id: 'enforcement/inspections' },
287+
items: [
288+
'enforcement/inspections',
289+
'enforcement/state-visa-overlap',
290+
'enforcement/infraction-notices',
291+
'enforcement/fines-appeal',
292+
'enforcement/interdicao-seizure',
293+
'enforcement/registration-cancellation',
294+
],
295+
},
296+
{
297+
type: 'category',
298+
label: 'Digital Health & SaMD',
299+
link: { type: 'doc', id: 'digital-health/framework' },
300+
items: [
301+
'digital-health/framework',
302+
'digital-health/samd-brazil',
303+
'digital-health/ai-ml-samd',
304+
'digital-health/mobile-health-apps',
305+
'digital-health/cybersecurity',
306+
'digital-health/lgpd-interface',
307+
],
308+
},
309+
{
310+
type: 'category',
311+
label: "What's New",
312+
link: { type: 'doc', id: 'whats-new/regulatory-changes' },
313+
items: [
314+
'whats-new/regulatory-changes',
315+
'whats-new/draft-rdcs',
316+
'whats-new/audiencias-publicas',
317+
'whats-new/upcoming-changes',
318+
'whats-new/recall-tracker',
319+
'whats-new/mercosul-updates',
320+
],
321+
},
322+
],
4323
};
5324
export default sidebars;

‎sites/cn/docs/china-agent/_category_.json‎

Lines changed: 5 additions & 0 deletions
Original file line numberDiff line numberDiff line change
@@ -0,0 +1,5 @@
1+
{
2+
"label": "China Agent (\u4ee3\u7406\u4eba)",
3+
"position": 6,
4+
"collapsed": true
5+
}

‎sites/cn/docs/digital-health/_category_.json‎

Lines changed: 5 additions & 0 deletions
Original file line numberDiff line numberDiff line change
@@ -0,0 +1,5 @@
1+
{
2+
"label": "Digital Health & SaMD",
3+
"position": 11,
4+
"collapsed": true
5+
}

‎sites/cn/docs/enforcement/_category_.json‎

Lines changed: 5 additions & 0 deletions
Original file line numberDiff line numberDiff line change
@@ -0,0 +1,5 @@
1+
{
2+
"label": "Enforcement & Compliance",
3+
"position": 13,
4+
"collapsed": true
5+
}

‎sites/cn/docs/guidance/_category_.json‎

Lines changed: 5 additions & 0 deletions
Original file line numberDiff line numberDiff line change
@@ -0,0 +1,5 @@
1+
{
2+
"label": "Guidance Documents",
3+
"position": 9,
4+
"collapsed": true
5+
}

‎sites/cn/docs/international/_category_.json‎

Lines changed: 5 additions & 0 deletions
Original file line numberDiff line numberDiff line change
@@ -0,0 +1,5 @@
1+
{
2+
"label": "International & Comparison",
3+
"position": 10,
4+
"collapsed": true
5+
}

‎sites/cn/docs/legislation/_category_.json‎

Lines changed: 5 additions & 0 deletions
Original file line numberDiff line numberDiff line change
@@ -0,0 +1,5 @@
1+
{
2+
"label": "Legislation & Regulations",
3+
"position": 8,
4+
"collapsed": true
5+
}

‎sites/cn/docs/post-market/_category_.json‎

Lines changed: 5 additions & 0 deletions
Original file line numberDiff line numberDiff line change
@@ -0,0 +1,5 @@
1+
{
2+
"label": "Post-Market",
3+
"position": 4,
4+
"collapsed": true
5+
}

‎sites/cn/docs/pre-market/_category_.json‎

Lines changed: 5 additions & 0 deletions
Original file line numberDiff line numberDiff line change
@@ -0,0 +1,5 @@
1+
{
2+
"label": "Pre-Market",
3+
"position": 3,
4+
"collapsed": true
5+
}

‎sites/cn/docs/pre-market/classification/_category_.json‎

Lines changed: 5 additions & 0 deletions
Original file line numberDiff line numberDiff line change
@@ -0,0 +1,5 @@
1+
{
2+
"label": "Classification",
3+
"position": 1,
4+
"collapsed": true
5+
}

0 commit comments

Comments
 (0)