MFDS Revises Medical Device Manufacturing and Quality Management Standards

-

 


The Ministry of Food and Drug Safety (MFDS) has issued an administrative notice on September 5 regarding amendments to the 'Medical Device Manufacturing and Quality Management Standards' aimed at reducing the burden of on-site inspections for medical device manufacturers. The MFDS will collect opinions on these changes until September 26.

Key Changes in the Amendment:

1. Simplified Regular Inspections for High-Quality Manufacturers
Manufacturers with excellent quality systems will now have their regular inspections primarily conducted through document review, rather than on-site, and the inspection cycle will be extended from three to six years. The number of required submission documents is also reduced to six types.

2. Revised Conformity Assessment Criteria
For minor nonconformities with minimal impact on quality, the new criteria will allow conditional sales, provided corrective actions are completed within a specified timeframe.

3. Enhanced Standards for Quality Assessors
Qualification requirements for senior quality assessors will now include recognition of both domestic and overseas assessment experience. Additionally, assessors must complete mandatory training specified by the MFDS to maintain their qualifications.

These amendments aim to reduce regulatory burdens, accelerate product distribution, and enhance the reliability and professionalism of quality assessments in the medical device sector.

For more details, visit MFDS Website.


👉 Contact GCA

Tel. +82-31-360-8180
Email: forest.lee@gca-kr.com



Comments

Post a Comment

Popular posts from this blog

KC Certification-EMC | RF | SAR

-
Image
KC Certification-EMC | RF | SAR Korea Certification EMC testing typically covers the majority of electronic products marketed in Korea, and depending on the product's wireless functions, either RF or SAR testing may be required. This is a mandatory certification system operated by RRA and is divided into three parts: Certification of Conformity, Registration of Conformity, and Interim of Conformity. All products manufactured, imported, and sold in Korea shall be approved according to related procedures.   ▮  Certification of Conformity   Equipment that can harm Korea's radio environment or broadcasting communication network, as well as those whose normal operation can cause significant electromagnetic disturbances and/or be affected by radio waves, are subject to the certification of conformity. Products with wireless functions fall under this category. This includes 5G NR, LTE, MPR and more.  ▮  Registration of Conformity   Broadcasting and communication equipment (e.g.
Read more

Korea KC Certification

-
Image
  Certifications Required in Korea Required product certifications differ by country depending on the purpose and environment of use. It is important to recognize that Korea demands a wide range of product certification procedures, thus necessitating making preparations accordingly. Basic certifications are listed below (refer to the corresponding section for details) 1. Consumer products - KC certification: Electrical safety, EMC, energy efficiency, household goods, and children's products 2. Industrial equipment - KCs certification: Electrical and mechanical safety - KC certification: EMC 3. Medical devices: MFDS 4. Automotive components: KC certification 5. Chemicals - Act on Registration and Evaluation of Chemical Substances - Chemical Substances Control Act - Eco-Assurance System of Electrical and Electronic Equipment and Vehicles (EcoAS) - Consumer Chemical Products and Biocides Safety Control Act 6. Assessment of the materials and structure of packaging materials 👉 Contact
Read more

The utilization of outdoor mobile robots for delivery, patrol, and other new businesses is now permitted

-
Image
The revised Intelligent Robot Act, which came into effect on November 17, 2023, is expected to lead to an increasing encounter with robots delivering food or goods while walking on sidewalks. For the safety of pedestrians, robots allowed to move on sidewalks are restricted to a weight of 500 kg or less and a width of 80 cm or less. The speed of movement is regulated to be 5-15 km/h depending on the weight. To operate a business using robots, it is necessary to obtain operational safety certification from a designated certification authority. The certification authority will issue a safety certification, similar to a 'pedestrian license,' certifying the safe operation of the robot, after evaluating 16 criteria, including compliance with operational zones, pedestrian crossing, dynamic stability, speed control, and remote operation. Furthermore, the robot must comply with traffic laws, and in the case of jaywalking or violation of safety regulations, the operator may be subject to
Read more