03. Medical Goods Reporting System

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The Imported Medical Goods Reporting System in Korea.

to ensure the safety and quality of imported medical goods to protect public health.

The BIS license allows manufacturers to use the Standard Mark on their products.

This license is granted only if the products are made in the manufacturing facility and meet all the requirements of the applicable Indian Standards.

The Imported Medical Goods Reporting System is managed by the Ministry of Food and Drug Safety (MFDS) in South Korea to monitor and regulate imported medical goods. This system requires importers to report annual import performance data in compliance with the "Regulation on the Reporting of Production, Export, and Import Performance of Medical Products" (MFDS Notice No. 2022-94).

Applicable Products and How to Determine Applicability

Tampons, though primarily categorized as personal hygiene products, may also fall under "quasi-drugs" under the Pharmaceutical Affairs Act. To determine their inclusion:

Check Classification: Review the product classification on the Ministry of Food and Drug Safety (MFDS) database to verify if tampons are categorized as 의약외품.
Regulatory Guidance: Examine the product's intended purpose, labeling, and ingredients, particularly for sterilizing agents or medical benefits.
Expert Confirmation: Seek validation from MFDS or accredited agencies if uncertain.

Applicable Products and How to Determine Applicability

Tampons, though primarily categorized as personal hygiene products, may also fall under "quasi-drugs" (의약외품) under the Pharmaceutical Affairs Act (약사법). To determine their inclusion:

Check Classification

Review the product classification on the Ministry of Food and Drug Safety (MFDS) database to verify if tampons are categorized as "quasi-drugs".

Regulatory Guidance

Examine the product's intended purpose, labeling, and ingredients, particularly for sterilizing agents or medical benefits.

Expert Confirmation

Seek validation from MFDS or accredited agencies if uncertain.

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Which companies are subject to export performance reporting?

※ Article 49 of the Regulation on the Safety of Pharmaceuticals, etc. (Reporting of Production, Export, and Import Records of Pharmaceuticals, etc.)

① Pursuant to Article 38(2) of the Act, individuals who have obtained marketing authorization for pharmaceuticals and manufacturers of "quasi-drugs" shall report their annual production and export records to the Minister of Food and Drug Safety through corporations, such as the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, organized under Article 67 of the Act, in accordance with the guidelines prescribed and announced by the Minister of Food and Drug Safety. However, for finished pharmaceuticals [including "non-narcotics" but excluding medical compressed gases], quarterly reports of production or import records must be submitted to the Minister of Food and Drug Safety and to the head of the Comprehensive Information Center for Pharmaceuticals under Article 47-3(1) of the Act.

※ 「의약품 등의 안전에 관한 규칙」 제49조 (의약품 등의 생산·수출·수입 실적 등의 보고 등)

① 법 제38조제2항에 따라 의약품의 품목허가를 받은 자와 의약외품 제조업자는 해당 연도의 생산실적 및 수출실적을, 법 제42조제5항에 따라 의약품 등의 수입자는 해당 연도의 수입실적을 각각 식품의약품안전처장이 정하여 고시하는 바에 따라 한국제약바이오협회 등 법 제67조에 따라 조직된 사단법인을 통하여 식품의약품안전처장에게 보고하여야 한다. 다만, 완제의약품[한외마약(限外痲藥)을 포함하되, 의료용 고압가스는 제외한다]의 경우에는 분기별로 생산실적 또는 수입실적을 식품의약품안전처장 및 법 제47조의3제1항에 따른 의약품관리종합정보센터의 장에게 보고하여야 한다.