[CFDA] Guideline for Supplier Audit of Medical Device Manufacturer

In order to guide medical device manufacturer to conduct supplier audit, improve medical device safety, CFDA has formulated Guideline for Supplier Audit of Medical Device Manufacturer according to Good Manufacturer Practice of Medical Device and Administrative Measures for the Supervision of Medical Device Manufacturing, and issued on 2015.01.19.
Medical device manufacturer shall establish supplier examining and verifying system to audit and evaluate supplier, to ensure that the procurement of goods can meet the quality requirements of products according to Good Manufacture Practice of Medical Device

1. Application Scope

This guideline applies to relevant management of supplier for medical device manufacturer.
“Supplier” referred in this guideline is the enterprise or department which provide goods and services needed for medical device production.

2. Audit Principle

2.1 Sort management:

Manufacture shall take the quality as center and set up sort management system for procurement of goods and supplier based on their degree of influence on medical device.
Sort management shall consider the following:

Procurement of goods is standard component or custom-made component;
Complexity level of production process of procurement of goods;
Influence degree of procurement of goods on medical device quality and safety.
procurement of goods is provided by new supplier or old supplier.

2.2 Quality compliance:

Procurement of goods shall meet the quality requirement of medical device manufacturer and other relevant laws and regulation, and not less than national mandatory standards.

3. Audit procedure

3.1 Admittance audit

Medical device manufacturer shall formulate the supplier admittance requirement to audit and operation state, production ability, quality management system, product quality, and supply period of supplier according to the requirement of procurement of goods, which include category, acceptance criteria, model and specification, pattern, quantity, and so on, and keep a record. If necessary, manufacturer can conduct on-site audit, or production validation and evaluation of small sample to ensure that the procurement of goods meet the requirements.

3.2 Process audit

Manufacture shall establish audit procedure of procurement of goods during use to guarantee that the procurement of goods can meet the requirement during use. Review the processes which include stock check, production and use, finished product inspection, etc. and keep a record.

3.3 Evaluation management

Manufacturer shall establish evaluation system. Manufacturer shall evaluate the supplier regularly, and make regular audit report by analyzing the procurement of goods’ quality, technological level, delivery performance. The report is the necessary document in manufacturer quality management system self-inspection report. After evaluation, if manufacturer find that the supplier has great defect which can affect the quality of procurement of goods, manufacturer shall suspend purchase, analyze the risk provided by procurement of goods in time, and take corresponding measures.
If the key point factors such as production condition, model and specification, product technology, quality standards, which can affect the quality of product has been change, manufacturer shall request supplier to notify in advance, and re-evaluate the supplier. If necessary, manufacturer can conduct on-site audit.

4. Key point of audit

4.1 Document audit

Supplier qualification, which include business license, and other certificates for legal production or operation, etc.
Relevant documents of quality management system.
Production technique description of procurement of goods.
Procurement of goods performance, model and specification, safety evaluation report, self-inspection report or valid inspection report issued by quality inspection institutions.
Other documents and information stipulated in contract.

4.2 Stock inspection. Manufacturer shall conduct stock inspection according to relevant requirement, and ask for supplier to provide valid inspection report or other qualification certificate by batch.

4.3 On-site inspection. Manufacturer shall establish key-point of on-site inspection and inspection principle to review the factors which can affect the safety and quality of medical device, include supplier’s production environment, technological flow, production process, quality management, and so on. The special focus is that the inspection ability of supplier whether meet the requirements, and whether the supplier can guarantee that the goods meet the requirement permanently.

5. Special procurement of goods audit

5.1 If the special procurement of goods with cleanliness, manufacturer shall request supplier to provide certificate of cleanliness level of production condition, and conduct on-site inspection of supplier’s related condition and requirements.

5.2 If the special procurement of goods comes from an animal, manufacturer shall review the document such as qualification certificate, animal quarantine certificate, animal epidemic prevention certificate, etc. If necessary, manufacturer can conduct expand inspection of feeding condition, feed, storage and transportation, and so on.

5.3 If the procurement of goods is allogeneic material, manufacturer shall review the legitimacy verification or validation profile of ethics committee, donor card, technical requirement of donor screening , and so on.

5.4 If service provided by the supplier is sterilization service, manufacturer shall review its qualification certification and operation ability, and conduct on-site inspection.

For the supplier who provides measurement, clean, transportation services, manufacturer shall review its qualification certificate and operation ability, and conduct on-site inspection if necessary.
Manufacture sign the supply contract or agreement with supplier who provide service, shall clarify that supplier shall provide relevant record, such as sterilization period, temperature, strength, etc. if there is special requirement of storage condition, supplier shall provide storage condition record of transportation.

6. Other

6.1 Manufacturer shall designate relevant department or personnel to be responsible for supplier audit. Audit personnel shall familiar with relevant law and regulation, and have professional knowledge and work experience.

6.2 Manufacturer shall sign quality agreement with main supplier, stipulated the technical requirements and quality requirements of procurement of goods, and clarify quality responsibilities for both sides.

6.3 Manufacturer shall establish supplier file, which include contract or agreement, procurement of goods list, supplier qualification certificate, quality standard, acceptance criteria, and so on.

Ms. Windy Jin,
Medical Device Legislation Compliance Deportment, CIRS China;
11F Dongguan Building, 288 Qiuyi Road, Binjiang District, Hangzhou, China, 310020
Email: Windy@cirs-group.com

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