한국에서 수출되는 화장품의 말레이시아 인허가 등록에 대한 사항(영문 버전)

To export cosmetics to Malaysia, you must complete the pre-notification procedure through the National Pharmaceutical Regulatory Authority (NPRA) system under the Malaysian Ministry of Health, in accordance with the ASEAN Cosmetic Directive (ACD).

Since this system operates on a Cosmetic Notification framework rather than a Registration method, the process leading to final issuance proceeds relatively quickly, provided the documentation is perfectly prepared.

1. Key Requirements and Cosmetic Notification Holder (CNH): Only local Malaysian entities (SSM registered) can be the subject of the notification.

Since Korean manufacturers or brand companies cannot apply directly, you must designate a local official importer or agency (an independent CNH entity) and grant them a Letter of Authorisation (LOA).

Manufacturing Facility Requirements: The production plant must hold ISO 22716 or Good Manufacturing Practice (GMP) certification to proceed with the notification. 2. Key Step-by-Step Registration Procedure

Registration with the Malaysian NPRA proceeds in two main steps through the online system, Quest3+.

1) Quest3+ System Membership Registration and USB Token Application: Duration: 1–2 weeks. The local entity (CNH) creates a system account by submitting documents to the Malaysian Companies Commission (SSM) and the representative's identification. A digital USB token for security authentication must be issued to proceed to the next step.

2) Product Information Entry and Document Submission: Conducted online. Accurately enter the product name, ingredient list (INCI), manufacturer information, and intended use into the Quest3+ system, and upload required documents (Certificate of Free Sale, GMP, draft label, etc.).

3) Government Fee Payment and Screening: Cost: RM 50 per product/variant. After submission, if a screening fee of RM 50 per product is paid, the NPRA conducts regulatory screening to review ingredient compliance and labeling details.

4) Issuance of Declaration Confirmation (NOT Number): Duration: 1–2 weeks. Upon passing the review, a Notification Note (NOT Permit) is issued immediately, allowing for import and distribution. This number is required for formal customs clearance.

3. Essential Documents and Checklist

These are the key materials that the Korean brand company must prepare so that the local partner (CNH) can register them in the system. All documents must be written in English.

1) Certificate of Free Sale (CFS): An English certificate issued by organizations such as the Korea Cosmetic Association.

2) Manufacturer's GMP / ISO 22716 Certificate: The manufacturer's English certificate.

3) Qualitative & Quantitative Formula: A document specifying the INCI names and exact mixing ratios (%) of all ingredients.

4) Letter of Authorization (LOA): A document stating that the product owner delegates declaration authority to the local CNH. 5) Product Label and Box Design Artwork (2D File): The product name, usage instructions, full list of ingredients, country of manufacture (Made in Korea), and CNH information must be indicated in English or Malay (Bahasa Malaysia).

⚠️ Post-Market Management Precautions (PIF Retention Obligation): The validity period of the issued NOT number is two years, and it must be renewed at least one month prior to expiration.

Additionally, by law, local CNHs are required to retain the Product Information File (PIF) on their own.

Failure to immediately present this PIF during random post-market surveillance or on-site inspections by the NPRA may result in the revocation of the license or the imposition of fines; therefore, ingredient safety assessment data and other relevant information must be thoroughly shared.