PRODUCT
Product Authenticity
製品構造、機能、パラメータ、使用方法は提出資料と一致していなければなりません。
ABOUT BASIC LAW
Turn the technical facts of complex products intoproduct definitions that regulators can understand and verify.
Basic Law focuses on China regulatory pathways and product compliance for imported and domestic beauty devices. Starting from overseas technical dossiers or domestic R&D versions, we organise intended purpose, mechanism of action, technical parameters, risk controls, verification evidence and market operation into an executable product system.
01中国への輸入
02製品再構築
03分類判断
04継続管理
OUR POSITION
私たちの専門手法は、長期かつ複雑な輸入マイクロカレント案件から始まりました。
この案件を通じ、難しいのは提出そのものではなく、海外の技術的事実を中国の規制体系が理解できる製品ロジックに変換することだと確認しました。
海外の取扱説明書、試験資料、市場ポジショニングをそのまま中国へ持ち込むことはできません。名称、用途、パラメータ、ソフトウェア、付属品、試験、市場表現を中国の規制文脈で再整理する必要があります。
Basic Law has since applied the same method to domestic microcurrent, ultrasound, ion-air, radiofrequency, and light-based devices: understand the product before choosing the path, establish evidence before organising the submission, and keep R&D, importation, instructions, and market operation aligned.
EVIDENCE
Complete Evidence
リスク管理と実験検証は製品定義を支えるものでなければならず、単独の報告書を積み重ねるだけでは不十分です。
MARKET
事業上の一貫性
取扱説明書、研修、EC、代理店募集、販売店の宣伝は同一のコンプライアンスロジックを維持する必要があります。
WHAT WE SOLVE
私たちは、製品が技術・規制・市場をまたぐ際に生じる構造的な断絶を解決します。
For imported devices, these breaks often occur between overseas dossiers and China-specific definitions. For domestic devices, they often occur between R&D versions, submission materials, and sales claims.
01IMPORT TO CHINA
輸入機器の中国規制ルート
Review overseas technical documentation, the actual product, and the China market plan to establish the China product name, intended purpose, evidence system, and classification pathway.
02PRODUCT REBUILD
製品コンプライアンス再構築
Build an executable product version around the name, intended purpose, function set, output parameters, operating logic, and risk controls.
- 機能・パラメータ境界
- 取扱説明書・使用ロジック
- 開発バージョンの一貫性
03EVIDENCE SYSTEM
エビデンス・申請体系
Organise risk identification, verification objectives, test plans, and classification arguments into a mutually supporting evidence chain.
04MARKET CONTINUITY
上市後の継続的一貫性管理
A determination is not the end point. Product upgrades, training materials, e-commerce pages, livestream scripts, and distributor claims can all change how the product is actually presented in the market.
BASIC LAW METHOD
実際の製品から6段階のコンプライアンス工程を構築します。
Each step answers a specific question and provides verifiable input for the next, preventing R&D, submission, and sales teams from creating different versions of the product.
使用目的
Confirm target users, use settings, and non-medical purpose.
作用原理
Identify the principal mechanisms and possible physiological effects.
技術パラメータ
Define boundaries for frequency, current, energy, temperature, pressure, and duration.
リスク管理
Implement structural, software, operational, and warning controls.
実験検証
Support the product definition with safety and intended-purpose evidence.
一貫性を維持
Align submissions, instructions, training, e-commerce, and version updates.
WORKING PRINCIPLES
明確な専門的境界は、長期プロジェクトを成立させる前提です。
We do not trade lower fees or simplified judgement for project volume. We protect client investment through staged assessment, defined deliverables, and consistency with the real product.
Our goal is not to change product status through wording, but to build a compliance pathway supported by the actual product, verification evidence, and real market operation.
製品と資料の一貫性
The target regulatory pathway must be based on the real product definition and risk controls. Formal documentation must match the product actually manufactured, imported, and sold.
プロジェクト契約前の評価
Before a complex device enters a full project, its dossier, mechanism, and pathway feasibility should be assessed.
各段階の成果には独立した価値がある
Product reconstruction, test design, dossier systems, and project management each produce confirmable professional deliverables; value is not reduced to the final administrative outcome.
認定は終点ではない
Product upgrades, sales claims, and distributor conduct must remain consistent with the determination dossier.
PROJECT OVERVIEW
進行中Compliance Project Management
現在の段階Submission Dossier Confirmation
進捗68%
対応事項02
Dossier Collection製品再構築実験検証Classification Submission
Technical Parameter Confirmation完了Intended Purpose Confirmation進行中Additional Verification Records未処理
お客様向けファイルProject Work Plan.pdfDossier Confirmation Checklist.docx
COMPLIANCE OPERATING SYSTEM
Turn professional judgment into a traceable project process.
Formal projects use the Basic Law Compliance Project Platform for progress, tasks, client documents, and file management. The platform turns complex work into confirmable stages, versions, and responsibility records while protecting internal review materials, submission strategy, and commercial information.
01Project stage and current milestone
02Client tasks and document uploads
03File versions and approval records
04Result delivery and annual management
コンプライアンスセンターへ
WORK WITH BASIC LAW
Obtain a decision-ready path assessment before committing to the full project cost.
Submit instructions, technical parameters, operating principle, product images, and target market. A consultant will first confirm dossier readiness; projects requiring substantive technical judgement will proceed to a formal regulatory-path diagnosis with a defined scope.
Basic Law輸入・中国国内美容機器の規制および製品コンプライアンス
- 会社
- Basic Law（北京）ブランドマネジメント有限公司
- 電話
- 189 1026 3383
- メール
- zuo.basiclaw@outlook.com
- 住所
- 中国・北京市北京経済技術開発区