Good Manufacturing product
Medical device quality management confirmity recognition
Korea Testing and Research Institute(KTR) conducts GMP suitable tasks after registered as medical device quality review agency based on manufacture of medical device and notificaiton of quality management standard notified by Ministry of Food and Drug Safety.
Quality management suitable task based on Medical Appliances Act
- - GMP recognized by Domestic and overseas manufacturer
- - GMP recognized for medical device for clinical test
- - GMP recognized for export and grade 1st medical device
Subject item
26 medical device all items
Handling procedure for medical device GMP recognized work
- 1. 신청접수
의료기기 제조 수입업체 → 품질관리 심사기관 : 의료기기 GMP 심사 신청
- 2. 심사협의
의료기기 제조 수입업체 ↔ 품질관리 심사기관 : 제조소 현장심사 일정 등 상호 협의
지방식품 의약품 안전청 ↔ 품질관리 심사기관 : [2등급 제외] 지방청 심사원 선정 등 협의, 지방청 검토
- 3. 일정 및 심사계획 통보 (품질관리 심사기관 → 의료기기 제조 수입업체)
의료기기 제조 수입업체 : 현장심사 준비
- 4. GMP 심사 실시
-
5-1. 적합할 경우
- 현장심사 준비
- 지방청 검토
5-2. 보완사항이 있을 경우, 보완 공문 발송, 보완사항 지정.
- 적합할 경우 : 현장심사 준비
- 부적합할 경우 : 지방청 검토
Necessary document for confirmity (GMP)
Registration method
Visit or through post ( GMP certificatio center 3-107(Jungang-dong ), Gyoyukwon-ro 98, Gwacheon-si, Gyeonggi-do)
| Name of attachment document | Note(For reference) |
|---|---|
| 0-1 Check list for document | - |
| 0-2 Agreement on offering personal information | |
| 1-3 Application form for confirmity certification | |
| 1-4 Copy of permission certificate for medical device manufacture(import) | Exclude if there is no approval |
| 1-5 Copy of GMPconfirmity certificate | Except for first time evaluation |
| 2-A. Outline of factory | Description of name, location, range of manufacture, name of person in charge in quality, and contact number (overseas factory) |
| 2-B. Total number of employees | Include all employees directly or indirectly working in ,manufactuer and quality management of medical device |
| 2-C. List for manufacture(import) medical deivce | - |
| 2-D. Copy for quality management system confirmity certificate (* Only if you are required) | Production country’s GMP confirmity certificate or ISO 13485 confirmity certificate |
| 2-E. Outline for facility in factory : Ground plan, manufacture(test) facility/List for equipment |
|
| 2-F. Main supplier's location and range of work (Including consignment process contract, etc.) |
|
| 2-G. Actual inspection result from other certification agency (※ Only if you are required) | Submission of report that can check information within recent 3 years or an actual inspection result after change of location (Certification agency, Type of actual inspection, period, results). |
| 2-H. Quality manual (Including quality policy) - Import is document of overseas factory! | Data that can check quality manual( Including quality guideline) ※ Recent, effective quality related document or signed copy after certain manufacturer got approval |
| 2-I. Quality management plan(Domestic manufacture)/Product standard(Import- DMR document of overseas factory | Standard for representative item among requested item ※ Recent, effective quality related document or signed copy after certain manufacturer got approval |
| 2-J. Others - Copy of business license, etc. | Required for tax registration |
| 2-K. Copy of technical document | Submission prior to item approval due to GMP evaluation |
For client-manufacturer relationship, client documents must be submitted
| Name of attachment document | Note(For reference) |
|---|---|
| 1. Proof for relationship between clinet-manufacturer | Data explaining relationship of client and manufacturers in quality management system |
| 2. Outline for client | Description of name, location, range of manufacture, name of person in charge in quality, and contact number (overseas factory) |
| 3. Quality management system confirmity certificate for client | Production country’s GMP confirmity certificate or ISO 13485 confirmity certificate |
| 4. Actual inspection result from other certification agency (* Only if you are required) | Submission of report that can check information within recent 3 years or an actual inspection result after change of location (Certification agency, Type of actual inspection, period, results). |
| 5. Quality manual for client | Information you can check quality manual (Including policy on quality) ※ Recent, effective quality related document or signed copy after certain manufacturer got approval |
Note during registration for inspection
After preparing documents appropriate for each matter, once documents are confirmed estimat will be sent separately. BY paying cost for inspection, you will be registered officially.
Commission fee
MD (Registration of inspection by one person per day)
| Manufacturing classification | Hired employees | Evaluate MD |
|---|---|---|
| Overseas Manufacturer | - | 4MD |
| Domestic Manufacturer | 1~25 | 2MD |
| 26 ~ 65 | 3MD | |
| 66 ~ 125 | 4MD | |
| 126 ~ 175 | 5MD | |
| 176 ~ 275 | 6MD | |
| 276 ~ 425 | 7MD |
Field evaluation fee
Application fee(For the first time/Regular 375,000 won or Change evaluation 64,000won ) + Evaluation fee(533,000won per 1MD) + Fee for business trip
Standard for fe for business trip
- - Overseas: Calculated based on travel expenses for public official
- - Domestic: Calculated based on location of inspection
Document evaluation fee
Application fee(For the first time/regular evaluation 375,000 won or Change/Extra evaluation 64,000 won) + Evaluation fee(300,000 won per case)
Counseling
Medical device GMP technology support consultation
- Tel : +82 2-2092-4000
- fax : +82-2635-6100
Relevant regulation and reference for guideline
Officer who deals with quality management of medical equipment and person in charge should look up inforamtion page in homepage of Ministry of Food and Drug Safety-Medical Equipment Department since it has many relevant data about work.
Following information is necessary to conduct quality management of medical device so please refer to it.
