结论：注册人对产品负总责，但具体检测由谁做、谁出钱要写进协议
注册人制度下，注册人对产品的安全有效性负总责，这一点没有争议。容易出现模糊的是执行层面：注册检验、出厂检验、定期的型式检验，分别由谁安排、谁承担费用、报告归谁、出现不合格时谁处理。
这些事如果只在口头约定，项目顺利时看不出问题，一旦出现不合格或者监管检查，责任边界就会变成争议焦点。
各阶段检测的责任归属
| 检测类型 | 通常的责任方 | 需要在协议中明确的点 |
|---|---|---|
| 注册检验 | 注册人 | 样品由谁提供、费用由谁承担、报告归属 |
| 出厂检验 | 受托方执行 | 项目清单、判定依据、记录保存与查阅权 |
| 进货检验 | 受托方执行 | 关键物料清单、检验项目、放行规则 |
| 定期型式检验 | 注册人组织 | 频次、由谁送样、不合格时的处置流程 |
| 变更引发的检测 | 注册人决定 | 谁发起、谁执行、费用分担 |
| 不良事件调查检测 | 注册人主导 | 受托方的配合义务与时限 |
这张表里最容易出问题的是第二行和第六行。
出厂检验由受托方执行，但项目清单和判定依据由注册人确定。实际中常见的问题是：注册人给了一份清单，受托方按自己的理解执行，两边对某一项的方法理解不同，数据就不可比。建议协议里不只列项目名称，还要写明执行的方法条款和判定值。
不良事件调查涉及的检测通常时间紧、压力大。如果协议里没有约定受托方的配合义务和响应时限，临时协调会很被动。
样品从哪来，这件事要写清楚
注册检验用的样品，应当来自能代表量产状态的产品。委托生产的情形下，这意味着样品要由受托方按正式工艺生产。
这里有个实务问题：注册检验通常发生在受托方尚未完成全部生产准备的阶段。 用试制件送检，后续可能被质疑代表性；等全部准备就绪再送检，时间上又来不及。
可行的处理方式是分两步：先用试制件做摸底，确认设计没有问题；待工艺稳定后用正式工艺生产的样品做注册检验。这样既控制了风险，又不至于把时间全压在最后。协议里应当写明样品的提供方、批次要求和费用归属。
记录的保存与查阅
检测记录的保存责任要分清。受托方执行的检验，原始记录通常由受托方保存，但注册人应当有随时查阅的权利，并且在合作终止时有权取得副本。
这一条在合作顺利时无关紧要，在更换受托方或者发生纠纷时非常关键。见过的情况是，注册人更换受托方后想调取历史检验记录，发现协议里没有约定，前一家不配合，追溯链条就断了。
建议在协议里写明三件事：记录的保存期限、注册人的查阅方式、合作终止时的移交清单。
出现不合格时的处理
出厂检验发现不合格，处理流程应当事先约定。核心是三个问题：谁有权决定处置方式、返工后的复检由谁执行、是否需要通报注册人以及时限。
默认应当是：处置方式由注册人决定，受托方不得自行放行。 这一条看起来理所当然，但在批量交付压力下，如果协议没有明确禁止，现场容易出现自行判断的情况。
协议之外的实际配合
协议写得再细，执行中仍然依赖双方的实际配合。有几处是纸面上不容易覆盖、但实际影响很大的：
样品的一致性。 注册检验用的样品和后续量产品，工艺应当一致。受托方在注册检验阶段格外用心、量产时回到常规工艺的情况并不罕见。这个差异在报告上看不出来，但会在后续的监督抽检中暴露。
变更的及时通报。 受托方为了改善生产效率做的工艺微调，未必会主动告知注册人。而其中有些调整是可能影响产品特性的。协议里应当明确哪些类型的调整必须事先通报。
检测异常的沟通路径。 出厂检验出现临界值或者趋势性偏移时，受托方是等到超标才报，还是发现趋势就通报，两种做法的风险差别很大。
多个受托方的情形
同一产品由多家受托生产时，问题会复杂一层：各家的出厂检验数据要具备可比性，否则无法判断产品在不同产地之间是否一致。
可行的做法是统一检验方法与设备要求，并定期安排比对：同一批样品分送各家检测，对比结果差异。差异超出预期时，要查是方法执行的差异还是产品本身的差异。
这项工作的成本不低，但对于多产地生产的产品，它是证明一致性的主要手段之一。
报告的使用边界
还有一点值得写明：受托方用于内部质量控制的检测报告，通常不适合直接用于注册申报，反过来也一样。两者的样品来源、抽样方式、项目范围都不同。
实际中见过把出厂检验报告当注册资料提交的情况，形式上是一份检测报告，但抽样依据和项目覆盖都不满足注册要求。协议里把两类报告的用途分别写清楚，可以避免这种误用。
我们的做法
我们承接委托生产模式下的检测时，会先确认委托主体是谁——是注册人直接委托，还是受托方代为委托。这决定了报告抬头、结果告知对象和后续沟通路径。
报告抬头这件事看似形式，实际影响不小。注册申报用的报告，抬头通常应当是注册人；而受托方内部质量控制用的报告，抬头是受托方更合适。同一批样品如果两边都要用，需要在委托阶段就说清楚，出报告之后再改抬头是很麻烦的事。
如果你正在搭委托生产的质量协议，检测相关条款有不确定的地方，可以把草稿里相关章节发过来一起看，或者直接联系：132 4819 8029。能力范围见服务介绍，流程见检测流程，其他问题见常见问题。
English version
Conclusion: the registrant carries overall responsibility, but who performs and pays for each test must be written down
Under a marketing-authorisation-holder model, the registrant carries overall responsibility for the safety and performance of the device. That much is uncontroversial. What becomes blurred is execution: who arranges registration testing, routine release testing and periodic type testing, who pays, who owns the report, and who handles a nonconforming result.
Where these are settled only verbally, nothing surfaces while the project runs smoothly. As soon as a nonconformity or an inspection occurs, the boundary of responsibility becomes the point of dispute.
Allocating responsibility by test type
Registration testing is normally the registrant's responsibility; the agreement should state who supplies samples, who bears the cost, and who owns the report. Release testing is performed by the contract manufacturer, but the item list and acceptance basis are set by the registrant, and the agreement should cover record retention and the registrant's right of access. Incoming inspection is performed by the contract manufacturer against a key-material list and release rules defined jointly. Periodic type testing is organised by the registrant, with frequency, sample provision and the handling of nonconforming results all specified. Testing triggered by a change is decided by the registrant, with initiation, execution and cost sharing defined. Testing in support of an adverse event investigation is led by the registrant, and the contract manufacturer's duty to cooperate and the response time should be stated.
Two of these cause most of the trouble. For release testing, the registrant supplies a list and the contract manufacturer executes it according to their own reading; where the two sides understand a method differently, the data are not comparable. The agreement should therefore specify not only item names but the method clauses and acceptance values. For adverse event investigations, testing is usually urgent; without an agreed duty to cooperate and a response deadline, coordination under pressure is difficult.
Where samples come from
Samples for registration testing should represent the production configuration. Under contract manufacturing, that means they should be produced by the contract manufacturer using the definitive process.
A practical difficulty follows. Registration testing often happens before the contract manufacturer has completed all production preparation. Submitting pilot-build units invites questions about representativeness; waiting for full readiness may not fit the schedule.
A workable approach is to split it: use pilot units for preliminary testing to confirm the design, then use units from the definitive process for registration testing once it is stable. The agreement should state who provides samples, what batch requirements apply, and who bears the cost.
Retention of and access to records
Records from tests performed by the contract manufacturer are normally retained by them, but the registrant should have the right to inspect at any time and to obtain copies if the relationship ends.
This matters little while cooperation is good and a great deal when a contract manufacturer is replaced or a dispute arises. A registrant who changes manufacturer and then seeks historical inspection records may find the agreement silent, the previous party uncooperative, and the traceability chain broken.
The agreement should state three things: how long records are kept, how the registrant may access them, and what is handed over if the arrangement ends.
Handling nonconforming results
The process should be agreed in advance. Three questions matter: who decides the disposition, who performs retesting after rework, and whether and how quickly the registrant must be notified.
The default should be that disposition is decided by the registrant and the contract manufacturer may not release on its own authority. This seems obvious, but under delivery pressure and without an explicit prohibition, on-the-spot judgements do occur.
How we handle it
For work under a contract manufacturing arrangement we first establish who the client is: the registrant directly, or the manufacturer acting on their behalf. That determines whose name appears on the report, who is informed of results, and how subsequent communication runs.
The name on the report looks like a formality and is not. A report used for registration should generally be in the registrant's name, while a report used for the manufacturer's internal quality control is better issued to them. Where both parties need to use results from the same samples, this must be settled when the work is commissioned; changing the report holder afterwards is troublesome.
If you are drafting a quality agreement for contract manufacturing and the testing clauses are unclear, send us the relevant sections. Phone or WeChat: +86 132 4819 8029.